[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clear-cell-renal-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clear-cell-renal-cell-carcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,32,0,25,[9,45,75,104,124,151,175,213,242,262,288,309,330,358,376,397,425,447,473,495,536,558,579,621,638],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100566941","phase-3-testing-the-addition-of-the-anti-cancer-drug-tivozanib-to-immunotherapy-pembrolizumab-after-surgery-to-remove-all-known-sites-of-kidney-cancer-100566941",false,"NCT06661720","Testing the Addition of the Anti-Cancer Drug Tivozanib to Immunotherapy (Pembrolizumab) After Surgery to Remove All Known Sites of Kidney Cancer","Short TeRm Intensified Pembrolizumab (KEytruda) and Tivozanib for High-Risk Renal Cell Carcinoma - STRIKE","STRIKE","Inclusion Criteria:\n\n* • Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features following complete resection of the primary tumor (radical or partial nephrectomy)\n\n  * Note: Patients with microscopically positive soft tissue or vascular margins without gross residual disease are permitted\n\n    * Intermediate-high risk RCC:\n\n      * pT2 grade 4 or sarcomatoid features, N0M0\n      * pT3 any grade N0, M0\n    * High-risk RCC\n\n      * pT4, any grade, N0, M0\n      * pT, any stage., any grade, N+, M0\n    * cM1 no evidence of disease (NED) RCC\n\n      * Participants who have had resection of primary tumor (radical or partial nephrectomy) and resection or definitive radiation or ablation of solid, isolated, soft tissue metastases (excluding brain and bone lesions) at the time of primary tumor removal (synchronous) or ≤1 year from primary tumor removal (metachronous)\n\n        * Surgery (radical or partial nephrectomy or metastasectomy or ablation) \\> 4 weeks but =\\\u003C 16 weeks prior to study registration with no ongoing complications from surgery\n        * No evidence of disease at time of randomization as assessed by investigator by either CT or MRI scan of the brain and chest, abdomen and pelvis\n        * No prior systemic treatment for RCC\n        * Age \\>= 18 years\n        * Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (or Karnofsky \\>= 60%)\n        * Absolute neutrophil count (ANC) \\>= 1,000\u002Fmm\\^3\n        * Platelet count \\>= 100,000\u002Fmm\\^3\n        * Hemoglobin \\>= 8 g\u002FdL\n        * Total bilirubin =\\\u003C 3 x upper limit of normal (ULN)\n        * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 x upper limit of normal (ULN)\n        * Calculated (calc.) creatinine clearance \\>= 30 mL\u002Fmin (using Cockcroft Gault equation or the estimated glomerular filtration rate from the modification of diet in renal disease trial)\n        * Urine protein =\\\u003C 1+ on urine analysis (UA) or urine protein creatinine ration (UPCR) \\\u003C 2mg\u002Fmg\n        * Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test is required =\\\u003C 14 days prior to registration\n        * HIV status: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n        * Hepatitis\n  * Hepatitis B: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with resolved HBV infection, defined as positive hepatitis B core antibody (anti-HBc) and negative hepatitis B surface antigen (HbsAg), are eligible\n  * Hepatitis C: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n\n    * Cardiac Disease: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class IIB or better\n    * No history of myocarditis\n    * No history of clinically significant pneumonitis\n    * No uncontrolled hypertension (systolic blood pressure \\[BP\\] \\> 150 mm Hg or diastolic BP \\> 90 mm Hg) documented on 2 consecutive measurements taken at least 2 hours apart\n    * No serious non-healing wound, ulcer or bone fracture within 28 days prior to registration\n    * No serious\u002Factive infection requiring parenteral antibiotics\n    * No moderate or severe hepatic impairment (child-Pugh B or C)\n    * No significant bleeding disorders within 1 month prior to registration, for example:\n  * Hematemesis, hematochezia or other gastrointestinal bleeding grade 3 or higher\n  * Hemoptysis of pulmonary bleeding grade 3 or higher\n  * Hematuria or other genitourinary bleeding grade 3 or higher\n\n    * No history of allogeneic organ transplantation\n    * No history of allergy of hypersensitivity to study drugs or components\n    * No condition requiring systemic treatment with either corticosteroid (\\> 10 mg daily or prednisone equivalent) within 14 days of treatment initiation or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids and adrenal replacement doses ≤10 mg daily prednisone equivalent are permitted in absence of active autoimmune disease\n    * No active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis or other gastrointestinal condition associated with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 4 weeks prior to registration\n    * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n    * No patients with a history of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids \\> 10 mg\u002Fday, or immunosuppressive drugs) with the following exceptions:\n  * Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed\n  * Brief (\\\u003C7 days) use of systemic corticosteroids is allowed when use is considered standard of care\n  * Patients with vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma\u002Fatopy will not be excluded\n  * Patients requiring intermittent use of bronchodilators, inhaled steroids, or local steroid injections will not be excluded\n  * Patients with hypothyroidism that is stable with hormone replacement or Sjögren's syndrome will not be excluded • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment","ALL","18 Years",{"count":21,"type":22},1040,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This phase III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Tivozanib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving pembrolizumab and tivozanib together may work better than pembrolizumab alone in treating patients with RCC.",[28,29,30,31],"Clear Cell Renal Cell Carcinoma","Renal Cell Carcinoma (RCC)","Stage II Renal Pelvis Cancer AJCC v8","Stage III Renal Pelvis Cancer AJCC v8","RECRUITING","2026-07-01",{"date":35,"type":36},"2026-07-02","ACTUAL",{"date":38,"type":36},"2025-03-14",{"date":40,"type":22},"2037-11",{"name":42,"class":43},"Alliance for Clinical Trials in Oncology","OTHER",415,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":7},"100480450","phase-1-a-phase-1-study-of-ab521-monotherapy-and-combination-therapies-in-renal-cell-carcinoma-and-other-solid-tumors-100480450","NCT05536141","A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors","A Phase 1, Open-label, Dose Escalation and Dose Expansion Study, to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB521 Monotherapy and Combination Therapies in Participants With Clear Cell Renal Cell Carcinoma and Other Solid Tumors","ARC-20","Key Inclusion Criteria:\n\n* Must have at least one measurable lesion per RECIST guidance\n* Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1\n* Disease-specific criteria for dose escalation:\n\n  * Participants may have any pathologically confirmed solid tumor type where no other treatment options are available\n  * Creatinine clearance ≥ 40 mL\u002Fmin\n\nDisease-specific criteria for dose-expansion:\n\n* Histologically confirmed ccRCC\n* Creatinine clearance ≥ 40 mL\u002Fmin\n\nKey Exclusion Criteria:\n\n* Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product\n* Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with a participant's participation in the clinical study or make the administration of investigational product hazardous\n* History of trauma or major surgery within 28 days prior to the first dose of investigational product\n* For all expansion cohorts: prior treatment with an hypoxia inducible factor (HIF)-2α inhibitor. For the casdatifan + cabozantinib combination cohort, any prior treatment with cabozantinib. For casdatifan + zimberelimab and casdatifan + zimberelimab + ipilimumab cohorts, any prior systemic treatment when cancer is present.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":54,"type":22},362,[56],"PHASE1","The purpose of this study is to evaluate the safety and tolerability of:\n\n* casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and\n* casdatifan monotherapy and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.",[28,59],"Solid Tumors",[28,61,62,63,64,65,66],"AB521","Casdatifan","Kidney Cancer","Zimberelimab","AB122","Hif2a",{"date":35,"type":36},{"date":69,"type":36},"2022-10-26",{"date":71,"type":22},"2029-03",{"name":73,"class":74},"Arcus Biosciences, Inc.","INDUSTRY",{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100550440","phase-2-an-investigational-scan-89zr-dfo-gmab-petct-compared-to-contrast-enhanced-ct-for-the-detection-of-recurrent-clear-cell-renal-cell-cancer-after-surgery-comparing-carbonic-anhydrase-ix-caix-pet-ct-to-conventional-pet-ct-for-post-op-staging-in-kidney-cancer-100550440","NCT06447103","An Investigational Scan (89Zr-DFO-GmAb PET\u002FCT) Compared to Contrast-Enhanced CT for the Detection of Recurrent Clear Cell Renal Cell Cancer After Surgery Comparing Carbonic Anhydrase IX (CAIX) PET CT to Conventional PET CT for Post-Op Staging in Kidney Cancer","89Zr-DFO-GmAb PET\u002FCT vs Contrast-Enhanced CT for Detection of Recurrent Clear Cell Renal Cell Carcinoma After Surgery","Inclusion Criteria:\n\n* Age ≥ 18\n* Histologically confirmed clear cell renal cell carcinoma (RCC) (ccRCC) (based on partial\u002Fradical nephrectomy\u002Fmetastasectomy)\n\n  * For tumors with extensive sarcomatoid features, if there is evidence of areas of clear cell and high CAIX expression throughout the tumor on immunohistochemistry, they will be allowed on study\n* Subjects must have undergone definitive treatment of their primary tumor (partial\u002Fradical nephrectomy) +\u002F- resection of metastatic disease to no evidence of disease (NED) with a prior nephrectomy \\\u003C 2 years)\n* Surgery must have been performed between 4-16 weeks at the time of planned imaging\n* Subjects are considered to have a high risk of recurrence based on the following criteria:\n\n  * Intermediate-high risk ccRCC:\n\n    * pathologic tumor stage 2 (pT2), grade 4, or sarcomatoid, N0, M0\n    * pathologic tumor stage 3 (pT3), any grade, N0, M0\n  * High risk ccRCC:\n\n    * pathologic tumor stage 4 (pT4), any grade, N0, M0\n    * pT any stage, any grade, number of positive nodes (pN+), M0\n  * M1 now NED: pathologically-confirmed ccRCC, undergoing a resection of a solitary, isolated soft tissue metastasis within two years from initial nephrectomy\n* Negative serum pregnancy tests in female patients of childbearing potential. (Women of child bearing potential \\[WOCBP\\] require a negative pregnancy test within 24 hours (urine) prior to receiving investigational product)\n* Consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-DFO-GmAb administration\n* Individual must be able to remain still and lie flat for duration of the diagnostic imaging procedure (less than 1 hour)\n\nExclusion Criteria:\n\n* Inability to provide written informed consent\n* Any evidence of residual disease or known metastasis at the time of planned 89Zr-DFO-GmAb administration\n* Prior post-operative imaging for confirmation of disease status\n* An untreated non-renal malignancy with the following exceptions:\n\n  * Low risk prostate cancer on active surveillance (National Comprehensive Cancer Network \\[NCCN\\] very low\u002Flow risk)\n  * Non-melanoma skin cancer\n* Any prior treated malignancy meeting the following characteristics:\n\n  * Treated stage I or II cancer from which the patient is currently in complete remission\n  * A stage III cancer from which the patient is progressing or has been disease-free for and has required active treatment (e.g. adjuvant or maintenance therapy) within the past 3 years prior to enrollment\n  * A hematologic malignancy from which the patient is currently in complete remission\n* Contraindication to the use of iodinated contrast-enhanced CT agents, based on:\n\n  * Severe allergy (for which pre-medication cannot limit adverse reactions) or\n  * Estimated glomerular filtration rate (GFR) ≤ 30 ml\u002Fmin\u002F1.73m\\^2\n* Prior use of systemic therapy treatment for kidney cancer (PD-1, PD-L1, tyrosine kinase or TOR inhibitor) or radiotherapy within 4 weeks of enrollment\n* Exposure to experimental diagnostic or therapeutic drug within 14 days from date of planned administration\n* Women who are pregnant or breastfeeding\n* Known hypersensitivity to girentuximab\n* Known inability to remain still and lie flat imaging procedure (about 30 minutes)",{"count":83,"type":22},91,[85],"PHASE2","This phase II trial compares the safety and effectiveness of 89Zr-DFO-GmAb positron emission tomography (PET)\u002Fcomputed tomography (CT) compared to contrast-enhanced CT after surgery in detecting clear cell renal cell cancer that has come back (recurrent). For some patients, the risk of recurrence after surgery remains high. Conventional CT methods, such as contrast-enhanced CT, may not detect small volume or micrometastatic disease. PET\u002FCT with radiotracers, such as 89Zr-DFO-GmAb, may improve detection of tumor cells. Girentuximab (GmAb), a monoclonal antibody, is tagged with zirconium-89, a radioactive atom (which is also known as an isotope). The zirconium-89 (89Zr) isotope is attached to girentuximab with desferrioxamine (DFO) and this combined product is called 89Zr-DFO-girentuximab. 89Zr-DFO-girentuximab attaches itself to a protein on the surface of clear cell renal cell tumor cells called CAIX. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 89Zr-DFO-GmAb. Because some cancers, including clear cell renal cell cancer, take up 89Zr-DFO-GmAb it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Using contrast agents with CT scan to enhance the images (contrast-enhanced CT) is standard of care imaging. 89Zr-DFO-GmAb PET\u002FCT may be safe and effective compared to contrast-enhanced CT in detecting recurrent clear cell renal cell cancer after surgery.",[28,88,89,90,91],"Sarcomatoid Renal Cell Carcinoma","Stage II Renal Cell Cancer","Stage III Renal Cell Cancer","Stage IV Renal Cell Cancer",[93],"Renal","2026-06-11",{"date":96,"type":36},"2026-06-15",{"date":98,"type":36},"2024-08-06",{"date":100,"type":22},"2030-12-01",{"name":102,"class":43},"Jonsson Comprehensive Cancer Center",1,{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":103},"100607378","phase-2-phase-ii-trial-of-single-agent-belzutifan-or-pembrolizumab-versus-combination-as-neoadjuvant-therapy-in-clear-cell-renal-cell-carcinoma-blaze-100607378","NCT07187778","Phase II Trial of Single Agent Belzutifan or Pembrolizumab Versus Combination as Neoadjuvant Therapy in Clear Cell Renal Cell Carcinoma (BLAZE)","Inclusion Criteria:\n\n* Biopsy proven clear cell renal cell carcinoma (ccRCC).\n\n  a. Extra tissue should be submitted if available for correlative analysis. Formalin-fixed paraffinembedded (FFPE) tissue blocks are preferred to slides. Details pertaining to tumor tissue submission can be found in the Lab Procedures Manual.\n* Has intermediate-high risk, high risk, or M1 ccRCC as defined by the following pathological tumor-node metastasis and tumor grading:\n\nIntermediate-high risk ccRCC\\*\n\n1. pT2 (by radiographic\u002Fsize criteria), Grade 4 or with sarcomatoid\u002Frhabdoid features (on biopsy), N0, M0\n2. pT3 (presence of tumor thrombus, perinephric and\u002For sinus fat invastion by imaging), any grade, N0, M0 High-risk ccRCC\\*\n3. pT4, any g.rade, N0, M0\n4. pT, any stage, any grade, N+, M0 M1 RCC participants who present with the primary kidney tumor, but also solid, isolated, soft tissue metastases that are planned to be completely resected at the time of nephrectomy are eligible (e.g. metastasis to ipsilateral adrenal gland).\n\n   * NOTE: Fuhrman Tumor Grade and\u002For WHO\u002FISUP Tumor Grade are required for all subjects entering the study.\n\n     • Evaluated by urology and approved as candidates for nephrectomy.\n\n     • Age ≥18 years and consent to participation.\n\n     • Performance status of 0-1 per Zubrod\u002FEastern Cooperative Oncology Group \\[ECOG\\] scale.\n\n     • Absence of distant metastases on imaging of chest, abdomen and pelvis within 42 days of enrollment (by CT, MRI, or PET imaging). Brain imaging is not required unless clinical suspicion per the treating provider.\n\n     • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\n     • Screening laboratory criteria include the following: a. ANC ≥1000, PLT ≥ 75, Hgb ≥9 (transfusion allowed if Hgb \\\u003C 1.5 or = to upper limit of normal\n\n     • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n\n     • Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (see below) prior to study entry and for the duration of study participation, including for 120 days after the last dose of pembrolizumab and 30 days after the last dose of belzutifan. WOCBP will be required to have a negative pregnancy test prior to cycle 1 day 1 of treatment, ≤24 hours prior to first dose of treatment. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n\n     • Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 30 days after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n\n     • This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n     o Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n     * History of hysterectomy or bilateral salpingo-oophorectomy.\n     * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n     * History of bilateral tubal ligation or another surgical sterilization procedure.\n\n       • Male participants are eligible to participate if they agree to the following during the intervention period and for at least 7 days after the last dose of study intervention:\n\n       • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR\n\n       • Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below:\n\n       \\- Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant\n\n   Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.\n\n   \\- Male participants must also agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex.\n\n   • Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n   • Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of pembrolizumab and 30 days after last belzutifan administration.\n   * Ability to understand and the willingness to sign a written informed consent document.\n\n   Exclusion Criteria:\n   * Has any of the following:\n\n\u003C!-- -->\n\n1. A pulse oximeter reading \\\u003C92% at rest, or\n2. Requires intermittent supplemental oxygen, or\n3. Requires chronic supplemental oxygen\n\n   • Patients who have had chemotherapy or radiotherapy for RCC prior to study.\n\n   • Patients who are receiving any other investigational agents.\n\n   • History of allergic reactions attributed to compounds of similar chemical or biologic composition to belzutifan, pembrolizumab, or other agents used in study.\n\n   • Prior systemic therapy with anti-PD1, PD-L1, PD-L2, or CTLA-4 or received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) ≤28 days prior to the first dose of study intervention.\n   * Diagnosis of immunodeficiency, active autoimmune disease (per Investigator's discretion), history of pneumonitis, active infection, or known additional malignancy other than RCC.\n   * Has a known history of HIV infection. Note: Testing for HIV at screening is only required if mandated by local health authority.\n   * Has a known history of HBV (defined as HBsAg reactive) or known active HCV (defined as HCV RNA \\[qualitative\\] is detected) infection.\n\nNote: Testing for HBV and HCV is only required if mandated by local health authority.\n\n• Patients who cannot fulfill study requirements for any reason.\n\n* Pregnant or breastfeeding women are excluded from this study because pembrolizumab is a Class-D agent with the potential for teratogenic or abortifacient effects and belzutifan has shown embryofetal toxicity in nonclinical studies\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\n  a. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are NOT excluded. Invasive cancers are allowed if treated and in complete remission for at least 3 years.\n* Has any known metastatic disease that is not planned to undergo surgical resection at the time of surgery (with the exception of ipsilateral adrenal metastases that are resectable at surgery).\n* Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction ≤6 months from Day 1 of study drug administration, or New York Heart Association Class III or IV congestive heart failure. Medically controlled arrhythmia stable on medication is permitted.\n* Has moderate to severe hepatic impairment (Child-Pugh B or C).\n* Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (eg, gastrectomy, partial bowel obstruction, malabsorption).\n* Has received prior treatment with belzutifan or another HIF-2α inhibitor.\n* Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (eg, bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study.\n\nNote: A current list of strong\u002Fmoderate inducers of CYP3A4 can be found at the following website:\n\nhttps:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-druginteractionstable-substrates-inhibitors-and-inducers • Has an active infection requiring systemic therapy.\n\n• Has active TB.",{"count":111,"type":22},10,[85],"To learn if belzutifan alone, pembrolizumab alone, or belzutifan and pembrolizumab in combination given before a total or partial nephrectomy (surgery to remove all or part of a kidney) can help to control locally advanced ccRCC.",[28],"2026-06-10",{"date":117,"type":36},"2026-06-12",{"date":119,"type":36},"2025-12-19",{"date":121,"type":22},"2029-07-19",{"name":123,"class":43},"M.D. Anderson Cancer Center",{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":23,"phases":133,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100472535","phase-1-study-of-xmab819-in-subjects-with-advanced-clear-cell-renal-cell-carcinoma-100472535","NCT05433142","Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma","A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb819 in Subjects With Relapsed or Refractory Clear Cell Renal Cell Carcinoma","Inclusion Criteria:\n\n* Subjects must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the local site investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Subjects who have relapsed and refractory ccRCC, pRCC, NSCLC, and CRC with evidence of disease progression on standard-of-care therapies\n* ECOG performance status of 0 or 1.\n* All subjects must have adequate tumor sample available (slides or archival FFPE blocks)\n\nExclusion Criteria:\n\n* Prior treatment with an investigational anti-ENPP3\u002FCD203c therapy\n* History of serious allergic or anaphylactic\u002Fhypersensitivity reaction to monoclonal antibody therapy\n* Systemic antineoplastic therapy within 5 half-lives on the first dose of study treatment.\n* Failure to recover from any clinically significant toxicity related to previous anticancer treatment\n* Have known active central nervous system metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable,\n* Active known autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus; residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and nonsteroidal anti-inflammatory drugs)\n* Evidence of any serious infection requiring IV anti-infective treatment within 14 days prior to the first dose of study drug\n* Have a known additional malignancy that is progressing or has required active treatment within the past 2 years",{"count":132,"type":22},307,[56],"The purpose of this study is to assess the safety and tolerability of XmAb®819 administered intravenous (IV) or subcutaneous (SC) in subjects with relapsed or refractory clear cell renal cell carcinoma and to identify the minimum safe and biologically active dose and the recommended dose (RD).",[28],[137,138,139,63,140,141],"Clear cell Papillary","RCC","Renal Cell Cancer","Lung Cancer","Colon Cancer","2026-06-09",{"date":94,"type":36},{"date":145,"type":36},"2022-06-13",{"date":147,"type":22},"2028-12",{"name":149,"class":74},"Xencor, Inc.",26,{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":23,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":174},"100595788","phase-2-adding-a-live-biotherapeutic-product-cbm588-to-pembrolizumab-for-the-treatment-of-renal-cell-cancer-after-surgery-100595788","NCT07037004","Adding a Live Biotherapeutic Product (CBM588) to Pembrolizumab for the Treatment of Renal Cell Cancer After Surgery","Impact of Microbiome Modulation With CBM588 in Combination With Pembrolizumab for Adjuvant Therapy of High-Risk, Resected Renal Cell Carcinoma (RCC)","Inclusion Criteria:\n\n* Be willing and able to provide informed consent for the trial\n* Histological confirmation of renal cell carcinoma (RCC) with a clear-cell or sarcomatoid component\n* Pathologic stage of pT2, G4 or sarcomatoid, N0M0; pT3, any grade, N0M0; pT4, any grade, N0M0; pTany, any grade, N+M0; or M1 no evidence of disease (NED) after resection\n* No prior systemic immunotherapy for RCC\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C 2\n* Males and females, ages ≥ 18\n* Any ethnicity or race\n* Calculated creatinine clearance ≥ 30 milliliters per minute (mL\u002Fmin) per the Cockcroft and Gault formula or serum creatinine \\\u003C 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\\u003C 3 x ULN (\\\u003C 5 x ULN if liver metastases are present)\n* Total bilirubin \\\u003C 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin up to 3.0 mg\u002FdL)\n* Adequate bone marrow function defined by any of the following laboratory test findings: white blood cells (WBC) \\> 2,000\u002Fmm\\^3, neutrophils \\> 1,500\u002Fmm\\^3, platelets \\> 100,000\u002Fmm\\^3\n* Female subjects of child-bearing potential and female partners of male subjects must agree to use a highly effective method of contraception during treatment and for at least 5 months after the last dose\n\n  * Highly effective methods of contraception include: tubal ligation, an approved hormonal contraceptive such as oral contraceptives, patches, implants, injections, rings or hormonally impregnated intrauterine device (IUD), or IUD\n\nExclusion Criteria:\n\n* Prior radiation or anti-PD1, anti-PDL1, or anti-CTLA-4 therapy for RCC\n* Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll\n* Active interstitial lung disease (ILD)\u002Fpneumonitis or history of ILD\u002Fpneumonitis requiring treatment with systemic steroids\n* Baseline pulse oximetry less than 92% \"on room air\"\n* Current use, or intent to use probiotics, prebiotics, yogurt, bacterial fortified foods and other natural supplements ≤ 2 weeks prior to treatment initiation and during the period of treatment\n* Any condition requiring systemic treatment with corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease\n* Uncontrolled adrenal insufficiency\n* Known medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results\n* Not recovered to ≤ grade 1 toxicities related to any prior therapy before administration of study drug\n* Women who are pregnant or breastfeeding\n* History of myocarditis or congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), as well as unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction 6 months prior to study entry",{"count":159,"type":22},62,[85],"This phase II trial compares the effect of adding a Live Biotherapeutic Product called CBM588 to pembrolizumab versus pembrolizumab alone in preventing return of disease (recurrence) after surgery for patients with renal cell cancer. Pembrolizumab is an immune checkpoint inhibitor. Immunotherapy with monoclonal antibodies such as pembrolizumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pembrolizumab is approved for the treatment of renal cell cancer after surgery. Research has shown that changes to the composition of the healthy bacteria in the body (the microbiome), may improve a patient's response to treatment with immunotherapy. CBM588, a Live Biotherapeutic Product (LBP) containing a bacteria called Clostridium butyricum, has been shown to improve outcomes in patients treated with immunotherapy for other types of cancer. Adding CBM588 to treatment with pembrolizumab after surgery may cause changes in the microbiome that improve patient response to treatment and reduce disease recurrence, compared to pembrolizumab alone.",[28,88,163,164,165],"Stage II Renal Cell Cancer AJCC v8","Stage III Renal Cell Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","2026-06-05",{"date":142,"type":36},{"date":169,"type":22},"2027-01-01",{"date":171,"type":22},"2028-10-24",{"name":173,"class":43},"City of Hope Medical Center",2,{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":184,"briefSummary":185,"conditions":186,"keywords":199,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":212},"100610425","phase-1-symbiotic-gu-08-a-study-to-learn-about-the-medicine-called-pf-08634404-dosed-alone-and-in-combination-with-other-anticancer-therapies-in-adults-with-locally-advanced-or-metastatic-renal-cell-cancer-100610425","NCT07227415","Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer","AN INTERVENTIONAL PHASE 1B\u002F2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY AND IN COMBINATION WITH OTHER ANTICANCER AGENTS IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA","Inclusion Criteria:\n\n* 18 years of age or older at screening\n* Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC with diagnosis confirmed by histology\u002Fcytology\n* At least one measurable (as defined by the investigator) and untreated lesion\n* Adequate hematologic, hepatic, cardiac and renal function\n* No prior systemic therapy for RCC (immunotherapy after surgery is allowed if received \\>12 months prior)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* All International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) based risk categories\n\nExclusion Criteria:\n\nParticipants may be excluded if they meet any of the following:\n\n* Known active brain lesions including leptomeningeal metastasis, brainstem, meningeal or spinal cord metastases or compression.\n* Clinically significant risk of haemorrhage or fistula\n* History of another malignancy within 3 years\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* active autoimmune diseases requiring systemic treatment within the past 2 years\n* uncontrolled cardiac and other comorbidities within 6 months prior to the first dose\n* Major surgery or severe trauma within 4 weeks before the first dose, or planned major surgery during the study\n* History of severe bleeding tendency or coagulation dysfunction\n* History of oesophageal varices, severe ulcers, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess or acute gastrointestinal bleeding within 6 months prior to the first dose\n* Acute, chronic or symptomatic infections\n* Participants with history of immunodeficiency",{"count":183,"type":22},224,[56,85],"This study is testing a new medicine called PF-08634404 and how it works in adults with advanced Renal Cell Carcinoma (RCC)- a type of kidney cancer that is either locally advanced (spread to nearby tissues) or metastatic (spread to other parts of the body). The study will look at the safety of the study medicine, when given alone or with other anticancer medicines, and how this type of cancer responds to them.\n\nTo join the study, participants must be adults; with locally advanced or metastatic RCC; who have not received treatment for their advanced kidney cancer.\n\nParticipants will receive study medicine either alone or with other anticancer medicines. The medicine will be given through intravenous (IV) infusions, which means it will be injected directly into a vein. All treatments will take place at clinical study sites, where trained medical staff will take care of participants during and after each visit.",[187,188,189,190,28,191,192,193,194,195,196,197,198],"Carcinoma, Renal Cell","Advanced Renal Cell Carcinoma","Renal Cancer","Renal Neoplasm","Metastatic Renal Cell Carcinoma","Clear-cell Metastatic Renal Cell Carcinoma","Carcinoma, Renal Cell Metastasis","Advanced or Metastatic Renal Cell Carcinoma","Carcinoma, Renal Cell, Advanced","Metastatic Renal Cell Cancer","Metastatic Renal Cell Carcinoma ( mRCC)","Metastatic\u002FAdvanced Renal Cell Carcinoma",[200,201,202],"Renal cell carcinoma","renal cancer","renal neoplasm","2026-06-03",{"date":205,"type":36},"2026-06-04",{"date":207,"type":36},"2026-02-10",{"date":209,"type":22},"2028-11-01",{"name":211,"class":74},"Pfizer",109,{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":23,"phases":222,"briefSummary":223,"conditions":224,"keywords":232,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":238,"leadSponsor":240,"locationsCount":111},"100616025","phase-1-open-label-phase-12-study-of-neo-811-in-subjects-with-locally-advanced-or-metastatic-non-resectable-clear-cell-renal-cell-carcinoma-100616025","NCT07300241","Open-Label Phase 1\u002F2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma","An Open-Label, First-in-Human, Phase 1\u002F2 Dose Escalation and Expansion Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma","Inclusion Criteria:\n\n* Subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma (ccRCC).\n* Subjects must have progressed on or refused standard therapies.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.\n* Estimated life expectancy, in the judgment of the Investigator, of at least 12 weeks.\n* Formalin-fixed paraffin-embedded (FFPE) tumor tissue, newly obtained or archival, is mandatory for enrollment to the study.\n* Measurable disease as defined by RECIST v1.1.\n* Adequate hematologic, hepatic, and renal function defined as:\n\n  * Hemoglobin ≥10 g\u002FdL,\n  * Absolute neutrophil count ≥1000 cells\u002FµL,\n  * Platelet count ≥100,000\u002FµL,\n  * AST and ALT ≤2.5 × ULN, or AST and ALT ≤5 × ULN for subjects with liver metastases,\n  * Total bilirubin ≤1.5 × ULN,\n  * Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin.\n* Subject can swallow oral medications and does not have a condition that could impair the oral bioavailability of the study drug.\n* Other inclusion criteria per protocol.\n\nExclusion Criteria:\n\n* Non-clear cell predominant RCC histologic subtypes.\n* Leptomeningeal disease or symptomatic active CNS metastases with exceptions for asymptomatic treated CNS metastases per protocol.\n* Prior or concurrent malignancies with exceptions per protocol.\n* History of hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV infection.\n* Other exclusion criteria per protocol.",{"count":221,"type":22},30,[56],"The NEO-811-101 study is an open-label, first-in-human, Phase 1\u002F2 dose escalation and expansion study testing NEO-811, an ARNT molecular glue degrader, in subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma. The study will test NEO-811 initially as a monotherapy.",[28,225,138,226,227,228,229,230,231],"Renal Cell Carcinoma","Clear Cell Renal Cell Carcinoma Metastatic","ccRCC","VHL-Associated Clear Cell Renal Cell Carcinoma","VHL-Associated Renal Cell Carcinoma","Kidney Cancer Metastatic","Kidney Cancers",[227,225,28,233,63],"VHL","2026-05-29",{"date":236,"type":36},"2026-06-02",{"date":119,"type":36},{"date":239,"type":22},"2027-09",{"name":241,"class":74},"Neomorph, Inc",{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":23,"phases":250,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":103},"100594744","phase-2-belzutifans-role-in-active-surveillance-versus-treatment-for-indolentmetastatic-clear-cell-renal-ccell-carcinoma-brave-rcc-100594744","NCT07023432","Belzutifan's Role in Active Surveillance Versus Treatment for Indolentmetastatic Clear Cell Renal Ccell Carcinoma (BRAVE-RCC)","Inclusion Criteria\n\n1. Metastatic clear cell renal cell carcinoma, with or without sarcomatoid features, clinically apparent less than 12 months.\n2. Male\u002Ffemale participants must be at least 18 years of age on the day of signing informed consent.\n3. IMDC risk score of 0 or 1.\n4. No prior systemic treatment for ccRCC. Adjuvant immunotherapy or targeted treatments allowed if progressive disease is noted at least 12 months after last dose of immunotherapy.\n5. Metastatic disease that is documented by imaging with CT or MRI and measurable by RECIST1.1.\n6. Participants must have signed and dated an Institutional Review Board (IRB)\u002FInstitutional Ethics Committee (IEC) approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal participant care.\n7. Karnofsky performance status ≥ 70% and ECOG PS 0 or 1\n8. Suitable for active surveillance in the medical judgment of the treating oncologist.\n9. Participants must have adequate organ and marrow function as defined below:\n\n   i. absolute neutrophil count ≥ 1.5 x 109\u002FL ii. platelets ≥ 100 x 109\u002FL iii. hemoglobin (Hgb) ≥ 9 g\u002FdL iv. total bilirubin ≤ 1.5 x Institutional upper limit of normal (ULN) v. AST(SGOT)\u002FALT(SGPT) ≤ 2.5 × institutional ULN vi. serum creatinine ≤ 1.5 × institutional ULN OR 24-hour clearance ≥ 40 mL\u002Fmin\n\n   \\*Aspartate aminotransferase (serum glutamic-oxaloacetic transaminase)-AST(SCOT)\u002F Alanine aminotransferase (serum glutamic-pyruvic transaminase)- ALT(SGPT)\n10. A minimum of 28 days from any major surgery prior to registration.\n11. Ability to swallow, retain, and absorb oral medication.\n12. Baseline oxygen saturation \\>92% on room air.\n13. Female Participants are eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n    * Is not a woman of child-bearing potential (WOCBP) OR\n    * Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 30 days after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.\n    * A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention.\n    * If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n    * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n    * Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n14. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 7 days after the last dose of study intervention:\n\n    * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR\n    * Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause as detailed below:\n\n      * Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.\n      * Male participants must also agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex.\n    * Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n15. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\nExclusion Criteria\n\n1. Known or suspected brain metastases or active leptomeningeal disease.\n2. Requires any supplemental oxygen (either intermittent or chronic)\n3. Other concurrent severe and\u002For uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with protocol\n4. Impairment of gastrointestinal function or disease that may significantly alter the absorption of belzutifan (e.g., uncontrolled nausea, vomiting, diarrhea, malabsorption syndromes, prior small bowel resection, or inflammatory bowel disease)\n5. Prior cardiovascular event including myocardial infarction, rest claudication, stroke, unstable angina, central nervous system (CNS) hemorrhage, unstable ventricular arrythmias, or severe congestive heart failure (NYHA Class 3 or higher) within the past 6 months\n6. Received colony-stimulating factors (eg, granulocyte colony stimulating factor, granulocytemacrophage colony stimulating factor or recombinant erythropoietin) ≤28 days prior to the first dose of study intervention.\n7. Has moderate to severe hepatic impairment (Child-Pugh B or C).\n8. Participants who have undergone major surgery ≤ 28 days prior to starting study drug, radiation ≤ 2 weeks prior to starting study drug, or who have not recovered from side effects of such therapy prior to registration.\n9. Has received any type of small molecule kinase inhibitor (including investigational agents) ≤2 weeks before randomization; any prior HIF-2a antagonist exposure.\n10. Has known hypersensitivity or allergy to the active pharmaceutical ingredient or any component of the study intervention (belzutifan) formulations.\n11. Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (eg, bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study.\n12. Active infection requiring systemic therapy within 14 days prior to treatment assignment.\n13. Has active tuberculosis.\n14. Active HBV (defined as HBsAg reactive and detectable HBV viral load) or active HCV (defined as HCV RNA \\[qualitative\\] is detected) infection.\n15. Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n16. Has uncontrolled HIV infection (history of HIV with CD4 count \\>400 and undetectable HIV viral load while on anti-retroviral therapy allowed).\n17. Pregnant women are excluded from this study. Women who are breastfeeding should discontinue prior to initiating treatment.",{"count":249,"type":22},78,[85],"To learn if belzutifan can help to control the disease in patients with metastatic RCC who are considered candidates for active surveillance and have not undergone previous systemic treatment. The safety of belzutifan in this patient population will also be studied.",[253,28],"Active Surveillance","2026-05-19",{"date":256,"type":36},"2026-05-22",{"date":258,"type":36},"2025-11-17",{"date":260,"type":22},"2030-04-14",{"name":123,"class":43},{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":272,"conditions":273,"keywords":274,"overallStatus":279,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":4},"100637100","phase-2-neoadjuvant-pd-l1-inhibitor-plus-anlotinib-for-kidney-preservation-in-complex-renal-cell-carcinoma-100637100","NCT07602101","Neoadjuvant PD-L1 Inhibitor Plus Anlotinib for Kidney Preservation in Complex Renal Cell Carcinoma","Neoadjuvant PD-L1 Blockade Combined With Anlotinib to Enable Nephron-Sparing Surgery in Patients With High-Complexity Locally Advanced Clear Cell Renal Cell Carcinoma","Inclusion Criteria:\n\n* • Age ≥18 years\n\n  * ECOG performance status 0-2\n  * Histologically confirmed clear cell renal cell carcinoma\n  * Clinical stage cT2-T3aN0M0 (AJCC 8th edition)\n  * RENAL nephrometry score ≥10\n  * Tumor assessed as requiring radical nephrectomy or complex partial nephrectomy\n  * Adequate organ function\n  * Signed informed consent\n\nExclusion Criteria:\n\n* • Prior systemic therapy for RCC (including ICIs or TKIs)\n\n  * Non-clear cell histology or sarcomatoid\u002Frhabdoid differentiation \\>20%\n  * Active autoimmune disease requiring systemic therapy\n  * Active uncontrolled infection (HBV\u002FHCV\u002FHIV)\n  * Prior organ transplantation\n  * Uncontrolled cardiovascular or pulmonary disease\n  * Pregnancy or breastfeeding",{"count":270,"type":22},33,[85],"This is a prospective, multicenter, single-arm phase II study evaluating the efficacy and safety of neoadjuvant PD-L1 inhibitor TQB2450 in combination with anlotinib in patients with locally advanced, high-complexity (RENAL score ≥10) clear cell renal cell carcinoma (ccRCC).\n\nThe primary objective is to determine whether neoadjuvant therapy can increase the rate of successful nephron-sparing surgery.\n\nIn addition, this study incorporates a pre-specified translational research platform including circulating tumor DNA (ctDNA) methylation-based minimal residual disease (MRD) monitoring, tumor multi-omics profiling, and radiomics analysis. Artificial intelligence-based models will be developed to predict treatment response and surgical conversion, enabling precision neoadjuvant strategies.",[28],[28,275,276,277,278],"Neoadjuvant Therapy","PD-L1","Anlotinib","Nephron-Sparing Surgery","NOT_YET_RECRUITING","2026-05-15",{"date":256,"type":36},{"date":283,"type":22},"2026-05-31",{"date":285,"type":22},"2028-12-31",{"name":287,"class":43},"RenJi Hospital",{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":23,"phases":298,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":306,"locationsCount":308},"100582438","phase-2-trial-of-zanzalintinib-xl092-in-combination-with-immunotherapy-in-patients-who-progress-on-adjuvant-therapy-in-clear-cell-rcc-100582438","NCT06863311","Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC","EXACT: Randomized Phase II Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC","EXACT","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent.\n3. ECOG Performance Status of 0-1 within 28 days prior to registration.\n4. Advanced or metastatic RCC with a clear cell component.\n5. Prior treatment must have included an anti-PD-1. Subjects must have progressed on or after adjuvant anti-PD-1 therapy. A washout period of 14 days prior to study treatment initiation is required. Subjects must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to Grade ≤ 1 or baseline. Unresolved grade 2 or greater toxicity from prior checkpoint inhibitor therapy will exclude a subject from enrolling. Subjects that received other systemic therapy after anti-PD1 are not eligible.\n6. Measurable disease per RECIST 1.1.\n7. Demonstrate adequate organ function as defined below. All screening labs are to be obtained within 2 weeks prior to registration.\n\n   * Absolute Neutrophil Count (ANC): ≥ 1500\u002Fmm3 without granulocytes colony-stimulating factor support within 2 weeks of screening laboratory collection\n   * Platelet Count (PLT): ≥ 100,000\u002Fmm3; without transfusion within 2 weeks of screening laboratory sample collection.\n   * Hemoglobin (Hgb): ≥ 9 g\u002FdL\n   * Serum Creatinine OR Calculated CrCl using Cockgroft Gault equation: Serum creatinine \\\u003C 1.5 upper limit of normal (ULN) OR calculated Cr Clearance \\>40mL\u002Fmin\n   * Urine protein-to-creatinine ratio (UPCR): ≤1mg\u002Fmg (≤ 113.2mg\u002Fmmol) creatinine\n   * Bilirubin: ≤ 1.5 × ULN (for subjects with Gilbert's disease \\\u003C 3 x ULN)\n   * Aspartate aminotransferase (AST): ≤ 3 × ULN\n   * Alanine aminotransferase (ALT): ≤ 3 × ULN\n   * Alkaline phosphatase (ALP): ≤ 3 × ULN. For subjects with documented bone metastasis ALP ≤ 5x ULN\n   * International Normalized Ratio (INR): ≤ 1.5 x ULN\n   * Activated Partial Thromboplastin Time (aPTT): ≤ 1.2 × ULN\n8. Females of childbearing potential must have a negative urine or serum pregnancy test within 2 weeks prior to registration. If a urine test is done and it is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n9. Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from penile-vaginal intercourse or to use an effective method(s) of contraception. Males able to father a child who are sexually active with female of childbearing potential must be willing to abstain from penile-vaginal intercourse or to use an effective method(s) of contraception.\n10. Known HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial. Testing is not required at screening unless mandated by local policy.\n11. Patients with known chronic hepatitis B virus (HBV) infection, must have an undetectable HBV viral load on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial. Testing is not required at screening unless mandated by local policy.\n12. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n\nExclusion Criteria:\n\n1. Prior treatment with Zanzalintinib.\n2. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days prior to study treatment initiation.\n3. Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 28 days prior to study treatment initiation unless otherwise specified.\n4. Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n\n4\\. Radiation therapy for bone metastasis within 14 days, any other radiation therapy within 28 days prior to study treatment initiation. Systemic treatment with radionuclides within 6 weeks prior to study treatment initiation. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n\n5\\. Known brain metastases or cranial epidural disease. Subjects adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 28 days prior to study treatment initiation may be eligible. NOTE: Subjects with an incidental finding of an isolated brain lesion \\\u003C 1 cm in diameter may be eligible after sponsor-investigator approval if the lesion is radiographically stable for 28 days prior to study treatment initiation and does not require treatment per Investigator judgement. NOTE: Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of study treatment initiation.\n\n6\\. Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 14 days prior to study treatment initiation.\n\n7\\. Active infection requiring systemic therapy. NOTE: Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n\n8\\. Positive TB test with active mycobacterial infection requiring systemic treatment.\n\n9\\. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).\n\n10\\. History of severe allergic anaphylactic reactions to study drug(s) or any of their excipients.\n\n11\\. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per treating physician discretion, are not eligible for this trial.\n\n12\\. Administration of a live, attenuated vaccine within 30 days prior to study treatment initiation.\n\n13\\. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis.\n\n14\\. Prior organ allograft including allogeneic stem cell transplant\n\n15\\. Inability to swallow oral medications. 16. Uncontrolled major cardiovascular, pulmonary, hematologic, or psychiatric illnesses that would make the subject a poor study candidate.\n\n17\\. Therapeutic doses of anticoagulants are not permitted in subjects with known brain metastases at study entry. NOTE: Subjects on therapeutic doses of LMWH or specified direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban, without known brain metastases who are on a stable dose of the anticoagulant for at least 7 days prior to randomization and without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor may be enrolled.\n\n18\\. Uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n• Unstable or deteriorating cardiovascular disease including but not limited to the following:\n\n* Congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias (eg, ventricular flutter, ventricular fibrillation, Torsades de pointes).\n* Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 140 mm Hg systolic or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment.\n* Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction, or other clinically significant ischemic event within 12 months before first dose.\n* Prior history of myocarditis. • Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous or non-CVA\u002FTIA arterial thromboembolic events within 6 months before to first dose. NOTE: Subjects with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and treated with anticoagulation per standard of care before first dose of study treatment. Subjects who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the sponsor-investigator.\n\n  * Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n* Known gastric or esophageal varices\n* Tumors invading the GI-tract from external viscera.\n* Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis.\n* Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months unless cause of obstruction is definitively managed and subject is asymptomatic.\n* Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose. NOTE: Complete healing of an intra-abdominal abscess must be confirmed before first dose.\n\n  * Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 mL) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose.\n  * Cavitating pulmonary lesion(s) or known endobronchial disease manifestation.\n  * Lesions invading major blood vessel including, but not limited to, inferior vena cava, pulmonary artery, or aorta. NOTE: Subjects with intravascular tumor extension (eg, tumor thrombus in renal vein or inferior V. cava) may be eligible following sponsor-investigator approval.\n\n    19\\. Other clinically significant disorders such as:\n  * Any active, known or suspected autoimmune disease. NOTE: Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n  * Any condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 2 weeks of first dose of study treatment. NOTE: Inhaled, intranasal, intra-articular, or topical steroids are permitted. Adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease. Transient short-term use of systemic corticosteroids for allergic conditions (eg, contrast allergy) is also allowed.\n  * Malabsorption syndrome.\n  * Serious non-healing wound\u002Fulcer\u002Fbone fracture. NOTE: Non-healing wounds or ulcers are permitted if due to tumor- associated skin lesions.\n  * Pharmacologically uncompensated, symptomatic hypothyroidism.\n  * Moderate to severe hepatic impairment (Child-Pugh B or C).\n  * Requirement for hemodialysis or peritoneal dialysis.\n  * History of life-threatening toxicity related to prior immune therapy (eg, anti-CTLA-4, or anti-PD-1\u002FPD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) except those that are unlikely to recur and manageable by standard of care treatment (eg, hypothyroidism).\n\n    20\\. Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to first dose. Prior laparoscopic nephrectomy within 4 weeks prior to first dose. Minor surgery (eg, simple excision, tooth extraction) within 10 days before first dose of study treatment. Complete wound healing from major or minor surgery must have occurred at least prior to first dose. NOTE: Fresh tumor biopsies should be performed at least 7 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible.\n\n    21\\. Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 450 ms for males or \\> 470 ms for females per electrocardiogram (ECG) within 14 days before first dose of study treatment. NOTE: If a single ECG shows a QTcF with an absolute value \\> 450 ms for males or \\> 470 ms for females, two additional ECGs at intervals of approximately 3 minutes must be performed within 30 minutes after the initial ECG, and the average of these three consecutive results for QTcF will be used to determine eligibility.\n\n    22\\. Subjects with inadequately treated adrenal insufficiency.",{"count":297,"type":22},70,[85],"The study population for this Phase 2 study will include men and women ≥ 18 with confirmed renal cell carcinoma who have progressed on adjuvant anti-PD-1\u002FPD-L1 therapy, the current standard of care. Subjects will be randomized to Arm A or Arm B. Study treatment will be given in 28-day (4 week) cycles. Arm A treatment will consist of zanzalintinib (XL092) alone and will be taken once daily continuously (Day 1-Day 28). Arm B treatment will consist of XL092 plus nivolumab. XL092 will be taken once daily continuously (Day 1-Day 28) and nivolumab will be administered every 4 weeks (Day 1). Treatment will continue until progression by RECIST 1.1, toxicity, or other reasons as appropriate.",[188,191,28],{"date":302,"type":36},"2026-05-18",{"date":304,"type":36},"2026-03-13",{"date":285,"type":22},{"name":307,"class":43},"Karie Runcie",4,{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":23,"phases":318,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":279,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":4},"100632644","phase-2-testing-the-safety-and-feasibility-of-immunotherapy-drugs-botensilimab-and-balstilimab-before-surgery-for-clear-cell-renal-cell-carcinoma-neo-robot-trial-100632644","NCT07516366","Testing the Safety and Feasibility of Immunotherapy Drugs, Botensilimab and Balstilimab, Before Surgery for Clear Cell Renal Cell Carcinoma, NEO RoBOT Trial","Pilot Phase II Trial Evaluating Safety and Feasibility of Neoadjuvant Botensilimab and Balstilimab in Clear Cell Renal Cell Carcinoma (NEO RoBOT)","Inclusion Criteria:\n\n* Patients must have biopsy-confirmed, non-metastatic, high-risk renal cell carcinoma (RCC) with a clear cell component, defined as clinical stage T2N0, T3N0, T4N0, or any T stage with N1 disease (i.e., T2a-T4NanyM0 or TanyN1M0), and no evidence of metastatic disease\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of botensilimab in combination with balstilimab in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (or Karnofsky ≥ 60%)\n* Patients must be considered suitable for curative-intent surgical resection of RCC, including radical or partial nephrectomy, as determined by the urology team and the treating physician according to standard clinical guidelines\n* Absolute neutrophil count ≥ 1,000\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN\n* Glomerular filtration rate (GFR) 50 mL\u002Fmin\u002F1.73 m\\^2\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Also including a prior history of renal cell carcinoma\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Patients must be scheduled to undergo either partial or radical nephrectomy as part of treatment plan\n* The effects of botensilimab and balstilimab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and 4 months after completion of treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of botensilimab and balstilimab administration. All patients of childbearing potential must undergo a blood or urine pregnancy test within 14 days prior to receiving the first dose of botensilimab and balstilimab to confirm they are not pregnant. If dosing is delayed beyond this window, the pregnancy test must be repeated to ensure results remain current\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n* Availability of pre-treatment archival slides or tissue blocks is required for inclusion in the study\n\nExclusion Criteria:\n\n* Patients who have suspected or proven metastatic renal cell carcinoma\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to botensilimab or balstilimab\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because botensilimab and balstilimab are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with botensilimab or balstilimab, breastfeeding should be discontinued if the mother is treated with botensilimab or balstilimab\n* Patients without a clear cell component in their baseline kidney biopsy or non-clear cell renal cell carcinoma (RCC) are excluded from this study\n* Patients who have received prior treatment for RCC, including surgery, radiation, thermos-ablation or systemic therapy including immune checkpoint inhibitors, or VEGF tyrosine kinase inhibitors (TKIs)\n* Patients who have received prior treatment with an anti-PD-1, anti-programmed cell death protein ligand 1 (PD-L1), anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways\n* Patients who have undergone major surgery within 28 days prior to the start of the study\n* Patients with any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive medications within 14 days prior to first dose of study drug; the exception would be for syndromes which would not be expected to recur in the absence of an external trigger. Inhaled steroids and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease\n* Patients with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll",{"count":317,"type":22},16,[85],"This phase II trial tests the effect of botensilimab and balstilimab before surgery (neoadjuvant) in treating patients with high-risk clear cell renal cell cancer that has not spread from where it first started to other areas of the body (non-metastatic). The current standard treatment for patients with non-metastatic clear cell renal cell cancer may include surgery to completely remove the tumor. This typically involves removing the kidney or part of the kidney (nephrectomy). Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving neoadjuvant botensilimab and balstilimab may be safe, tolerable, and\u002For effective in treating patients with high-risk non-metastatic clear cell renal cell cancer before undergoing a nephrectomy.",[28,163,164,165],"2026-05-14",{"date":280,"type":36},{"date":324,"type":22},"2026-08-21",{"date":326,"type":22},"2027-08-30",{"name":328,"class":329},"National Cancer Institute (NCI)","NIH",{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":339,"phases":4,"briefSummary":340,"conditions":341,"keywords":342,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":103},"100366637","evaluation-of-urinary-exosomes-presence-from-clear-cell-renal-cell-carcinoma-100366637","NCT04053855","Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma","PEP-C","Inclusion Criteria:\n\nPatients:\n\n* All patients with renal mass requiring surgery (partial or total nephrectomy)\n* Social security affiliation\n* Signed informed consent\n\nControl :\n\n* Unscheduled nephrectomy\n* Social security affiliation\n* Signed informed consent\n\nExclusion Criteria:\n\n* Insufficient volume of urine sample (\\\u003C 100 ml)\n* Patients with a urinary catheter\n* Patients under court-ordered guardianship or curators",{"count":338,"type":22},100,"OBSERVATIONAL","Clear cell renal cell carcinoma is diagnosed by imaging, sometimes associated with biopsy. This diagnosis is expensive, invasive and sometimes late. The development of a simple biological test for diagnosis is essential. Exosomes are 30 to 150 nm membrane vesicles secreted into the extracellular space by various living cells. These exosomes can be isolated from biological fluids, including urine. The recent study of urinary exosomes is a promising topic for analyzing tumor markers in urine. The investigator's goal is to develop a reliable technique for detecting tumor exosomes in urine in patients with clear cell renal cell carcinoma. The analysis of urinary exosomes could provide a new liquid biopsy tool for the early diagnosis of clear cell renal cell carcinoma.",[28],[343,344,345,346,347,348],"Clear cell renal cell carcinoma","Urinary exosomes","Detection","Electron microscopy technique","Flow cytometry","RT-qPCR","2026-05-05",{"date":351,"type":36},"2026-05-06",{"date":353,"type":36},"2020-01-29",{"date":355,"type":22},"2026-08-01",{"name":357,"class":43},"Centre Hospitalier Universitaire de Saint Etienne",{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":23,"phases":365,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":103},"100490252","phase-1-phase-1b2-study-of-combination-177lu-girentuximab-plus-cabozantinib-and-nivolumab-in-treatment-nave-patients-with-advanced-clear-cell-rcc-100490252","NCT05663710","Phase 1b\u002F2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC","Inclusion Criteria:\n\n1. Has the ability to understand and willingness to sign a written ICF before the performance of any study-specific procedures on this protocol and 2022-0515\n2. Age ≥ 18 years\n3. Has locally advanced or metastatic RCC with predominantly clear cell subtype\n4. Has at least one measurable lesion as defined by RECIST version 1.1\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1\n6. Has adequate organ function defined as follows:\n\n   a. Absolute neutrophil count ≥ 1,500\u002FµL, Hgb level ≥ 9 g\u002FdL and platelet count (Plt) i. ≥ 100,000\u002FµL without transfusion or growth factor support within 2 weeks prior to obtaining the hematology values at screening; b. Creatinine clearance ≥ 40 mL\u002Fmin\u002F1.73m2 c. Transaminase levels (AST\u002FALT) ≤ 3.0 × upper limit of normal (ULN); total bilirubin i. (TBILI) ≤ 1.5 mg\u002FdL in the absence of Gilbert's disease\n7. Women of child beariring potential must have a negative serum preganancy test within 7 days before first study drug administration\n8. Female patients of child bearing potential, or a male patients with a female partner of child-bearing potential (defined as all women physiologically capable of becoming pregnant), must agree to use a highly effective method of contraception during screening, during the period of drug administration and for 120 days after stopping study drug administration. Highly effective contraception methods include the following:\n\n   1. Total abstinence (defined as refraining from heterosexual intercourse during the entire period outlined above),\n   2. Male or female sterilization, or\n\n   Use of at least one of the following:\n\n   Use of oral, injectable, transdermal, intravaginal, or implantable hormonal methods of contraception i. Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation ii. Progestogen-only hormonal contraception associated with inhibition of ovulation c. Placement of an intrauterine device or intrauterine system\n9. Able to swallow oral medications\n10. Able to provide tumor tissue sample (archival or recent acquisition)\n11. Patients with brain metastases are eligible providing other measurable disease exists and brain lesions are controlled for one month (requiring no therapy) and are not life threatening.\n\nExclusion Criteria:\n\n1. Has received treatment with any frontline systemic therapy for metastatic RCC\n2. Has a history of leptomeningeal disease or spinal cord compression\n3. Has a history of autoimmune disease requiring active therapy\n4. Has a history of brain metastases except:\n\n   1. Patients may be enrolled if they have treated brain metastases with no evidence of progression or hemorrhage after therapy for brain metastases (e.g. radiation therapy, surgery, radiosurgery) AND\n   2. Patients may be enrolled if they do not require ongoing treatment with dexamethasone or anti-epileptic drugs\n5. Has had radiation therapy for bone metastases within 2 weeks, or any other external radiation therapy (5 days or longer) to sites other than bone, within 4 weeks before administration of the first dose of study treatment. Patients with clinically relevant ongoing major complications from prior radiation therapy are not eligible.\n6. Has uncontrolled or poorly controlled hypertension, as defined by a sustained blood pressure (BP) \\> 140\u002F90 with or without antihypertensive treatment\n7. Has had any major cardiovascular event within 6 months prior to study drug administration including but not limited to myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, pulmonary embolism, clinically significant ventricular arrhythmias (e.g. sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or New York Heart Association Class III or IV heart failure\n8. Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results, in the opinion of the investigator or medical monitor\n9. Has an active infection requiring systemic treatment\n10. Is participating in another therapeutic clinical trial\n11. Is receiving chronic concomitant treatment with strong CYP3A4 inducers or CYP3A4 inhibitors\n12. Has manifestations of malabsorption due to prior gastrointestinal (GI) surgery or GI disease\n13. Has GI disorders including those associated with a high risk of perforation or fistula formation:\n\n    1. Tumors invading the GI-tract, active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic or biliary duct, or gastric outlet obstruction\n    2. Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before administration of the first dose of study treatment. Note: complete healing of an intra-abdominal abscess must be confirmed before administration of the first dose of study treatment\n14. Has tumor invading or encasing any major blood vessels\n15. Has other clinically significant disorders such as:\n\n    1. Serious non-healing wound\u002Fulcer\u002Fbone fracture\n    2. Moderate to severe hepatic impairment (Child-Pugh B or C).\n    3. Requirement for hemodialysis or peritoneal dialysis\n    4. History of solid organ transplantation\n16. Has had major surgery (e.g., GI surgery, removal or biopsy of brain metastasis) within 2 months before the first study drug administration. Complete wound healing from major surgery must have occurred 1 month before the first study drug administration and from minor surgery (e.g., simple excision, tooth extraction) at least 10 days before the first study drug administration. Patients with clinically relevant ongoing complications from prior surgery are not eligible\n17. Has a prior or concomitant invasive malignancy other than RCC with the exception of adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma in situ or any other malignancy from which the patient has remained disease free for more than 2 years.",{"count":338,"type":22},[56,85],"To learn if giving 177Lu girentuximab in combination with cabozantinib plus nivolumab can help to control advanced clear cell renal cell carcinoma (ccRCC).",[368,28],"Advanced Cancer","2026-04-30",{"date":349,"type":36},{"date":372,"type":36},"2023-06-30",{"date":374,"type":22},"2027-10-30",{"name":123,"class":43},{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":383,"enrollmentInfo":384,"targetDuration":4,"studyType":23,"phases":386,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":279,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":103},"100636326","phase-1-phase-1-study-of-lnk001-in-advanced-or-metastatic-clear-cell-renal-cell-carcinoma-100636326","NCT07564232","Phase 1 Study Of LNK001 In Advanced Or Metastatic Clear Cell Renal Cell Carcinoma","A Phase 1 Study Of LNK001 (Dual ENPP3\u002FCAIX AND-gate CAR T Cell Therapy) In Advanced Or Metastatic Clear Cell Renal Cell Carcinoma","Inclusion Criteria:\n\n1. Patients with histologically or cytologically confirmed metastatic\u002Fadvanced RCC with a clear cell component who have received at least one prior line of systemic treatment in the advanced or metastatic setting, including at least one PD-1\u002FPD-L1 immune checkpoint inhibitor (ICI) and one tyrosine kinase inhibitor (TKI). Patients with locally advanced disease who are eligible for curative resection are excluded.\n\n   • For patients who received one prior line of therapy, they must have had evidence of disease progression. For patients who received 2 or more prior lines of therapy, evidence of progression is not required if they stopped treatment for intolerance.\n2. Confirmation of CAIX expression ≥ 50% at any intensity (greater than 0) by immunohistochemistry staining of the patient's primary renal tumor or a metastatic lesion biopsy specimen will be required for enrollment in the study. Both overall extent of expression and staining intensity will be scored. Archival tissues that exist prior to the time of enrollment will be used for this purpose.\n3. Patients must have at least one measurable site of disease per RECIST version 1.1.4.\n4. ECOG performance status ≤ 1.\n5. Age ≥ 18 years.\n6. Patients must have adequate organ and marrow function as defined below:\n\n   * Hemoglobin ≥ 8 g\u002Fdl\n   * Absolute neutrophil count ≥1,500\u002FmcL\n   * Platelets ≥100,000\u002FmcL\n   * Total bilirubin ≤ 1.5 mg\u002FdL; for patients with liver metastases or confirmed\u002Fsuspected Gilbert syndrome, TBIL ≤3 × ULN\n   * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 × institutional ULN; for patients with liver metastases, AST and ALT ≤ 5 × ULN\n   * Creatinine (CrCl) ≥ 30 mL\u002Fmin using either the Cockcroft-Gault formula or the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation\n7. INR and PT ≤ 1.5 x ULN and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy). Therapeutic anticoagulation with low molecular weight heparin (LMWH) or direct oral anticoagulant (DOAC) is permitted if the participant is on a stable therapeutic dose for at least 2 weeks at the time of enrollment.\n8. Left ventricular ejection fraction ≥ 45% by echocardiogram or MUGA scan.\n9. For patients with a history of chronic hepatitis B virus (HBV) and\u002For hepatitis C virus (HCV) infections, the HBV and HCV viral loads must be undetectable.\n10. Patients with a history of major psychiatric illness must be judged (by the treating physician) able to fully understand the investigational nature of the study and the risks associated with the therapy.\n11. The effects of LNK001 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n    * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n    * History of hysterectomy or bilateral salpingo-oophorectomy\n    * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy)\n    * History of bilateral tubal ligation or another surgical sterilization procedure.\n    * Female patients of childbearing potential (not postmenopausal for at least 12 months and not surgically sterile) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) before study entry. Pregnancy test must be repeated on the day of first infusion, if test performed \\> 14 days before starting study drug.\n    * Female patient of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 days after the last dose of the LNK001. Unsterilized male patients having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 90 days after the last dose of LNK001. Male patients with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of the treatment period until 90 days after the last dose of LNK001.\n\n    Approved methods of birth control are as follows:\n    * Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring)\n    * Intrauterine device (IUD)\n    * Tubal Ligation or hysterectomy\n    * Subject\u002FPartner post vasectomy\n    * Implantable or injectable contraceptives, and condoms plus spermicide\n    * Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control\n12. Ability to understand and the willingness to sign a written informed consent document for the clinical trial.\n13. Willingness to enroll in a 15-year long term follow-up surveillance protocol post LNK001 dosing.\n\nExclusion Criteria:\n\n1. Participants must not have any other malignancies requiring active treatment within the past 2 years except for in situ carcinoma of any site, or adequately treated (without recurrence post-resection or post-radiotherapy) carcinoma of the cervix or basal or squamous cell carcinomas of the skin, ductal carcinoma in situ of the breast or low-risk early-stage prostate adenocarcinoma with negligible risk of metastasis or death.\n2. Major surgical procedures or serious trauma within 4 weeks prior to enrollment or plans for major surgical procedures within 4 weeks after cell infusion (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to enrollment.\n3. History of major cardiovascular diseases prior to enrollment: unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade 2) or vascular disease (eg, aortic aneurysm at risk of rupture) that required hospitalization within 6 months prior to consenting, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia, clinically significant pericardial effusions).\n4. Symptomatic CNS metastases, leptomeningeal disease, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to enrollment, or potential need for CNS radiation within the first 28 days from LNK001 therapy.\n\n   • Patients with treated\u002Fstable brain metastases are allowed on protocol if they had brain metastases that received CNS-directed therapy, such as surgery or treatment with radiosurgery or Gamma knife, without recurrence or edema for at least 1 month (4 weeks). Patients actively requiring glucocorticoids for uncontrolled brain or leptomeningeal metastases are not eligible. Patients must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone ≤ 10 mg daily or equivalent).\n5. Active autoimmune diseases requiring systemic therapy (e.g., with disease-modifying drugs, prednisone \\>10 mg daily or equivalent, immunosuppressant therapy). However, the following will be allowed:\n\n   * Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.\n   * Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections.\n6. Ongoing treatment with systemic corticosteroid therapy at doses of prednisone \\> 10 mg\u002Fday or equivalent.\n7. Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n8. Prior ex vivo, in vivo, autologous or allogeneic CAR T therapy.\n9. Prior treatment with investigational therapeutics that target CAIX or ENPP3.\n10. Severe infection within 4 weeks prior to enrollment (e.g. patients requiring hospitalization, severe sepsis, or severe pneumonia with respiratory failure).\n\n    • Active ongoing infection requiring oral or IV antimicrobials prior to consenting.\n\n    Preventive antimicrobials are permitted\n11. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n12. Pregnant women are excluded from this study because LNK001 is a CAR T agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with LNK001, breastfeeding should be discontinued if the mother is treated with LNK001. These potential risks may also apply to other agents used in this study.\n13. Patient is breastfeeding or plans to breastfeed during the study.\n14. Patients with persistent non-hematological grade ≥2 adverse events per NCI CTCAE v6.0 from prior systemic therapies that would confound timely detection of adverse events due to LNK001 or otherwise hinder patient participation in the clinical trial.\n15. History or current evidence of any condition (medical \\[including adverse events from prior anticancer therapy, disorders secondary to tumor\\], surgical or psychiatric \\[including substance abuse\\]), or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, might lead to higher medical risk and\u002For is not in the best interest of the patient to participate, in the opinion of the treating investigator.","70 Years",{"count":385,"type":22},40,[56],"There are 2 parts to this clinical research study: Part 1 (Dose Escalation) and Part 2 (Dose Expansion).\n\nThe goal of Part 1 is to find the recommended dose of LNK001 in patients with advanced or metastatic ccRCC.\n\nThe goal of Part 2 is to learn if the recommended dose of LNK001 found in Part 1 can help to control the disease.",[28],"2026-04-27",{"date":391,"type":36},"2026-05-04",{"date":393,"type":22},"2026-10-01",{"date":395,"type":22},"2033-06-06",{"name":123,"class":43},{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":403,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":23,"phases":407,"briefSummary":408,"conditions":409,"keywords":4,"overallStatus":279,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":103},"100596296","phase-2-zanzalintinib-for-metastatic-clear-cell-renal-cell-carcinoma-with-bone-metastases-100596296","NCT07043608","Zanzalintinib for Metastatic Clear Cell Renal Cell Carcinoma With Bone Metastases","A Phase II Study of Zanzalintinib for Metastatic Clear Cell Renal Cell Carcinoma With Bone Metastases in Patients Previously Treated With Immune Checkpoint Inhibitors","ZAMBONI","Inclusion Criteria:\n\n1. Participants must have unresectable advanced or metastatic RCC with a predominant clear cell histologic component .\n2. At least three bone metastases are present and detectable on bone scan, and at least one bone metastasis is NOT planned to be treated with radiation therapy.\n3. Previously treated with 1-3 prior lines of therapy in at least one of the following settings:\n\n   1. Metastatic setting; must have received combination therapy containing either programmed cell death protein 1 (PD-1) inhibitor\u002Fcytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor or PD-1 inhibitor\u002Fvascular endothelial growth factor receptor (VEGFR)-targeting tyrosine kinase inhibitors (TKI).\n   2. Adjuvant setting; must have received pembrolizumab and have had documented progression of disease within 1 year of the first dose of pembrolizumab .\n4. Age ≥18 years.\n5. Has seen a dentist within 90 days prior to enrollment and been cleared to receive bone-strengthening agents.\n6. Availability of a representative formalin fixed, paraffin embedded tumor specimen or fresh frozen tissue specimen that enables the definitive diagnosis of RCC, accompanied by an associated pathology report. If stored specimens are not available, an optional biopsy may be performed and specimens can be collected by surgical resection or biopsy of the primary tumor or biopsy or resection of a metastatic lesion.\n7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n8. Demonstrates adequate organ function as defined below within 14 days prior to first study treatment:\n\n   1. Absolute neutrophil count (ANC) \\>=1,500\u002F μL (without granulocyte colony stimulating factor support within 2 weeks prior to Cycle 1, Day 1).\n   2. Platelets ≥100,000\u002F μL (without transfusion within 2 weeks prior to Cycle 1, Day 1).\n   3. White Blood Cell count (WBC) counts ≥ 2500\u002FμL.\n   4. Lymphocyte count ≥ 500\u002FμL.\n   5. Hemoglobin ≥9.0 g\u002FdL.\n\n      Participants may be transfused or receive erythropoietic treatment to meet this criterion:\n   6. Serum bilirubin ≤ 1.5 x upper limit of normal (ULN). Participants with known Gilbert disease who have serum bilirubin level \\\u003C= 3 x ULN may be enrolled.\n   7. Aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase (SGOT) ≤2.5 X institutional upper limit of normal.\n   8. Alanine aminotransferase (ALT)\u002Fserum glutamic-pyruvic transaminase (SGPT) ≤2.5 X institutional upper limit of normal.\n   9. Alkaline phosphatase ≤2.5 X institutional upper limit of normal. For participants with documented liver metastases: AST and\u002For ALT ≤ 5 x ULN. For participants with documented liver or bone metastases: alkaline phosphatase ≤ 5 x ULN.\n   10. Creatinine ≤ 1.5 x within institutional upper limit of normal OR creatinine clearance ≥ 40 mL\u002Fmin by institutional standard AND urine protein-creatinine ratio (UPCR) 1mg\u002Fmg.\n   11. International Normalized Ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN. This applies only to participants who are not receiving therapeutic anticoagulation; participants receiving therapeutic anticoagulation should be on a stable dose.\n   12. Serum ionized calcium above lower limit of normal and ≤ 1.5 x ULN.\n9. If any Grade ≥1 toxicities occurred in relation to prior treatment, patients must have recovered to baseline or ≤ Grade 1 unless adverse events are clinically insignificant or stable on supportive medication if needed.\n10. Ability to understand and the willingness to sign a written informed consent document.\n11. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n12. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n13. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n14. Sexually active fertile subjects and their partners must agree to use highly effective method of contraception (defined in Appendix 4) during the course of the study and for the following durations after the last dose of treatment (whichever is later). An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.\n\n    a. Through 186 days after the last dose of zanzalintinib for women of childbearing potential (WOCBP) or through 96 days after the last dose of zanzalintinib for men.\n15. Female subjects of childbearing potential must not be pregnant at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes. In addition, females \\\u003C 55 years-of-age must have a serum follicle stimulating hormone (FSH) level \\> 40 milli-international units per millilitre (mIU\u002FmL) to confirm menopause). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff. Exception: women who are not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and\u002For uterus).\n\nExclusion Criteria:\n\n1. Prior treatment with zanzalintinib for RCC.\n2. Receipt of any small molecule kinase inhibitor (including investigational) or vascular endothelial growth factor (VEGF)-targeted therapy within 2 weeks before the first dose of study treatment.\n3. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Note: Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment. Note: Base of skull lesions without definitive evidence of dural or brain parenchymal involvement are allowed.\n4. Participants requiring whole brain radiotherapy (WBRT).\n5. Incomplete healing from prior radiotherapy as determined by the treating radiation oncologist or treating investigator.\n6. Participation in an experimental drug study within 28 days of study enrollment.\n7. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.\n8. Pregnant and lactating women are excluded from this study because zanzalintinib is an investigational product with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with zanzalintinib, breastfeeding should be discontinued if the mother is treated with zanzalintinib.\n9. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Cycle 1, Day 1.\n10. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation); Clinically significant hematuria, hematemesis, or hemoptysis of \\>0.5 tsp (2.5ml) of red blood or other history of significant bleeding within 12 weeks before first dose of study treatment.\n11. Clinical signs or symptoms of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding.\n12. Evidence of abdominal free air not explained by paracentesis or recent surgical procedure.\n13. Concomitant anticoagulation with coumarin agents, direct thrombin inhibitors, factor Xa inhibitor betrixaban, or platelet inhibitors. Other anticoagulants are allowed.\n\n    1. Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n    2. Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n\n    i. Participants who have known brain metastases and who require therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban are not eligible for this study.\n\n    ii. Participants with known brain metastases and who are taking prophylactic low-dose aspirin for cardioprotection or low-dose (prophylactic-dose) low molecular weight heparin are eligible.\n\n    Note: Subjects must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer.\n14. Previously identified allergy or hypersensitivity to components of the treatment.\n15. Malignancy that requires anti-cancer directed therapy within the last 3 years. Exceptions include those cancers that are considered cured by local therapy (e.g. Basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of breast, bladder, or cervix) or other cancers that have low malignant potential and do not require systemic therapy (e.g. Gleason grade \\\u003C6 prostate adenocarcinoma).\n16. Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment.\n17. Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n18. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Note: Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment. Note: Base of skull lesions without definitive evidence of dural or brain parenchymal involvement are allowed.\n19. Any complementary medications (e.g., herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n20. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n    1. Congestive heart failure New York Heart Association Class 3 or 4, class 2 or higher, unstable angina pectoris, new-onset angina, serious cardiac arrhythmias (e.g., ventricular flutter, ventricular fibrillation, Torsades de pointes).\n    2. Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 140 mm Hg systolic or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment.\n    3. Stroke (including transient ischemic attack (TIA)), myocardial infarction, or other clinically significant arterial thrombotic and\u002For ischemic event within 6 months before first dose of study treatment.\n    4. Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous events within 3 months before first dose of study treatment.\n\n       Note: Subjects with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n\n       Note: Subjects who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the Principal Investigator.\n    5. Prior history of myocarditis.\n    6. Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n\n    i. Tumors invading the GI-tract from external viscera. ii. Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis.\n\n    iii. Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months before first dose unless cause of obstruction is definitively managed and subject is asymptomatic.\n\n    iv. Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.\n\n    v. Known gastric or esophageal varices. vi. Ascites, pleural effusion, or pericardial fluid requiring drainage in last 4 weeks.\n21. Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 mL) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study treatment.\n22. Symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed).\n23. Lesions invading major blood vessel including, but not limited to, inferior vena cava, pulmonary artery, or aorta. Note: Subjects with intravascular tumor extension (e.g., tumor thrombus in renal vein or inferior V. cava) may be eligible following Principal Investigator approval.\n24. Other clinically significant disorders that would preclude safe study participation.\n\n    1. Active infection requiring systemic treatment. Note: Prophylactic antimicrobial treatments (antibiotics, antimycotic, antiviral) are allowed.\n    2. Known infection with acute or chronic hepatitis B or C, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness except for subjects meeting all of the following criteria: (1) on stable anti-retroviral therapy; (2) Cluster of differentiation 4 positive (CD4+) T cell count ≥ 200\u002FµL; and (3) an undetectable viral load. Note: HIV testing will be performed at screening if and as required by local regulation. Note: To be eligible, participants taking Cytochrome P450, family (CYP) inhibitors (e.g., zidovudine, ritonavir, cobicistat, didanosine) or Cytochrome P450, family 3 (CYP3) inducers (efavirenz) must change to a different regimen not including these drugs 7 days prior to initiation of study treatment. Anti-retroviral therapies (ART) must have been received for at least 4 weeks prior to the first dose. Note: CD4+ T cell counts, and viral load are monitored per standard of care by the local health care provider.\n    3. Serious non-healing wound\u002Fulcer\u002Fbone fracture. Note: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions.\n\n    i. Complete healing of intra-abdominal abscess must be confirmed before the first dose of study treatment d. Malabsorption syndrome. e. Pharmacologically uncompensated, symptomatic hypothyroidism. f. Moderate to severe hepatic impairment (Child-Pugh B or C). g. Requirement for hemodialysis or peritoneal dialysis. h. History of solid organ or allogeneic stem cell transplant.\n25. Major surgery (as defined in Section 6.6.2.3; e.g., GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to first dose of study treatment. Prior laparoscopic surgeries (i.e. nephrectomy) within 4 weeks prior to first dose of study treatment. Minor surgery (e.g., simple excision, tooth extraction) within 5 days before first dose of study treatment. Complete wound healing from major or minor surgery must have occurred at least prior to first dose of study treatment.\n\n    Note: Fresh tumor biopsies should be performed at least 5 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible.\n26. Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 480 ms within 14 days per electrocardiogram (ECG) before first dose of study treatment.\n\n    Note: Triplicate ECG evaluations will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility.\n27. History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.\n28. Patients who are ineligible for CT contrast AND who are unable to undergo MRI for any reason.\n29. Inability to swallow tablets or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy (PEG) tube.\n30. Other conditions, which in the opinion of the Investigator, would compromise the safety of the participant or the participant's ability to complete the study.",{"count":406,"type":22},20,[85],"This is a single-institution, phase 2 trial of zanzalintinib plus investigator-choice bone-strengthening agent in patients with metastatic renal cell carcinoma (RCC) with bone metastases whose disease has advanced on 1-3 prior lines of therapy, including at least one immune oncology-based (IO) therapy in the adjuvant or first-line metastatic setting.",[410,411,226,412,413,28,414,415,191,416],"Clear Cell Renal Cell Cancer (ccRCC)","Clear Cell Renal Carcinoma","Clear Cell Renal Cancer","Bone Metastases of a Malignant Tumor","Bone, Metastatic Cancer","Metastatic Cancer","Metastases to Bone",{"date":418,"type":36},"2026-05-01",{"date":420,"type":22},"2026-05-30",{"date":422,"type":22},"2030-02-28",{"name":424,"class":43},"Kelly Fitzgerald, MD",{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":18,"minAge":431,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":23,"phases":433,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":103},"100629056","phase-2-an-open-label-randomized-phase-2-clinical-trial-to-evaluate-the-efficacy-and-safety-of-the-combination-therapy-of-slc-3010-and-axitinib-compared-to-axitinib-monotherapy-as-a-second-line-treatment-for-locally-advanced-or-metastatic-clear-cell-renal-cell-carcinoma-100629056","NCT07469683","An Open-label, Randomized Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of the Combination Therapy of SLC-3010 and Axitinib Compared to Axitinib Monotherapy as a Second-line Treatment for Locally Advanced or Metastatic Clear Cell Renal Cell Carcinoma","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic ccRCC.\n\n   1. Part 1 (Safety Run-in): At least one first-line treatment of standard of care in the recurrent\u002Fmetastatic setting.\n   2. Part 2 (Phase 2): Anti-PD-1 (Programmed Cell Death Protein 1) or anti-PD-L1 (Programmed Cell Death-Ligand 1) monotherapy or combination therapy as first-line treatment in the recurrent\u002Fmetastatic setting.\n2. At least one measurable lesion as defined by RECIST (Response Evaluation Criteria in Solid Tumors) v1.1.\n3. Male or female patients aged ≥ 19 years at the date on which the informed consent is signed.\n4. Ability and willingness to provide written informed consent and to comply with all study procedures.\n5. Estimated life expectancy of ≥ 3 months.\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n7. Adequate organ functions as defined below. System organ class Laboratory test results\n\n   \\- Hematology\n\n   : Absolute neutrophil count (ANC) ≥ 1500 cells\u002FμL without the support of granulocyte colony-stimulating factor (G-CSF) within 2 weeks prior to the first dose of the study intervention.\n\n   Platelet count ≥ 100,000\u002FμL without the support of transfusion within 2 weeks prior to screening laboratory sample collection.\n\n   Hemoglobin ≥ 9 g\u002FdL without the support of transfusion within 2 weeks prior to screening laboratory sample collection.\n   * Coagulation\n\n     :International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × the upper limit of normal (ULN). If the patient is receiving anticoagulant therapy, PT shall be within the therapeutic range for the intended use of anticoagulants.\n   * Kidney\n\n     :Estimated glomerular filtration rate (eGFR) calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. ≥ 40 mL\u002Fmin\u002F1.73 m2\n   * Liver :Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with Gilbert's syndrome), or if total bilirubin is \\> 1.5 × ULN, direct bilirubin ≤ ULN.\n\n   Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN for patients with documented liver metastases).\n\n   Albumin ≥ 2.8 g\u002FdL\n8. If there were any clinically significant toxicities from prior therapies, they shall have resolved to Grade 0 or Grade 1 according to the NCI CTCAE v5.0 (Alopecia and ≤ Grade 2 endocrine-related adverse events related to prior immunotherapy (e.g., immune checkpoint inhibitors) that require medical treatment or hormone replacement therapy are considered acceptable for study participation.).\n9. Male and female patients of childbearing potential shall agree to use existing, highly effective contraception methods with the failure rate of \\\u003C1% (Appendix 1) during the treatment period and for 3 months after the last administration of the study intervention. Acceptable methods shall include barrier methods such as spermicide condoms or diaphragms. Women of childbearing potential (WOCBP) are defined as females who have experienced menarche and are not postmenopausal (including amenorrhea for at least 2 years without hormone therapy or surgical sterilization).\n10. WOCBP shall have a documented negative serum or urine pregnancy test at screening, performed within 3 days prior to the first administration of the study intervention. For non-childbearing females, one of the following shall be documented:\n\n    1. Postmenopausal status, defined as the absence of regular menstruation for at least 12 consecutive months with a documented serum follicle-stimulating hormone (FSH) level within the laboratory reference range for postmenopausal women, or\n    2. Documented history of hysterectomy or bilateral oophorectomy, or\n    3. Medically confirmed ovarian failure.\n\nExclusion Criteria:\n\n1. History of malignancy or active malignancy other than the target disease in this study. Exceptions are as follows:\n\n   1. Malignancies that have been treated with curative intent and have not recurred within the recent 2 years.\n   2. Completely resected basal cell carcinoma or squamous cell carcinoma of the skin.\n   3. Any type of completely resected carcinoma in situ.\n2. Known brain metastases or epidural conditions. However, patients who have been sufficiently treated with radiotherapy and\u002For surgery (including radiosurgery) and have been stable for at least 4 weeks prior to the first administration of the study intervention can be enrolled. Note: Patients with an incidental finding of a single lesion \\\u003C1 cm may be eligible if deemed not to require treatment at the discretion of the investigator. Eligible patients shall be neurologically asymptomatic and shall not have received corticosteroid therapy for at least 2 weeks prior to the first administration of the study intervention.\n3. Diagnosis of immunodeficiency or current use of chronic systemic corticosteroids or other immunosuppressive therapy within 7 days prior to the first administration of the study intervention. Topical (\\\u003C Grade III), inhaled corticosteroids, or intra-articular corticosteroids, topical creams\u002Flotions, mouthwashes containing corticosteroids, or mineralocorticoids (e.g., fludrocortisone) are allowed.\n\n   Note: Chronic use of ≤ 10 mg\u002Fday of prednisone or equivalent may be allowed after discussion and approval by the lead institution.\n4. Active autoimmune disease that has required systemic treatment (e.g., disease controllers, corticosteroids, or immunosuppressive drugs) within the recent 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal insufficiency or hypopituitarism) is not considered a form of systemic treatment.\n5. Known infection with Human Immunodeficiency Virus-1 (HIV-1) or HIV-2. Known active hepatitis B virus infection (i.e., HBsAg positive) or hepatitis C virus infection (e.g., \\[qualitatively\\] detectable HCV RNA). Patients with a negative HCV RNA test after a positive HCV antibody test and no ongoing anti-HCV therapy.\n6. Active infection requiring systemic therapy.\n7. Significant cardiovascular diseases, including but not limited to: Stable arrhythmias medically controlled with ongoing medication are allowed.\n\n   1. QT interval (Interval from the start of the Q wave to the end of the T wave of the ECG) corrected for heart rate using Fridericia's formula (QTcF) \\> 480 msec at screening\n   2. Myocardial infarction, acute coronary syndrome, or history of coronary angioplasty\u002Fstenting\u002Fbypass grafting within the recent 6 months.\n   3. Congestive heart failure (CHF) classified as New York Heart Association (NYHA) Class II-IV, or a history of NYHA Class III or IV CHF.\n8. Patients with significant respiratory symptoms, known or suspected serious or severe pulmonary conditions at screening, or requiring supplemental oxygen.\n9. Any form of systemic anticancer therapy (including investigational therapy) within 3 weeks prior to the first administration of the study intervention, or within 5 half-lives of the drug if known, whichever is shorter.\n10. Participation in an interventional clinical trial involving an investigational drug or device within 3 weeks prior to the first administration of the study intervention in this clinical trial. Patients who are participating in follow-up may be enrolled if more than 3 weeks have passed since the last administration.\n11. Radiotherapy within 2 weeks prior to the first administration of the study intervention. Patients with ongoing clinically related complications from prior radiotherapy are not eligible.\n12. Major surgery within 2 weeks prior to administration of the study intervention. Patients shall have sufficiently recovered from any toxicity and\u002For complications at the discretion of the investigator.\n13. Live vaccine administration within 4 weeks prior to the first administration of the study intervention. Administration of non-live COVID-19 vaccines within 7 days prior to the DLT assessment is contraindicated, as vaccine-related toxicity may interfere with safety assessments.\n14. Prior therapy using IL-2 (interleukin-2)-based drugs.\n15. History of prior axitinib treatment.\n16. Inability to swallow oral drugs or presence of gastrointestinal disorders that may affect absorption (e.g., gastrectomy, partial bowel obstruction, or malabsorption syndrome).\n17. Current administration of potent CYP3A4 inducers (e.g., mitotane, phenytoin, rifampin, carbamazepine, or St. John's Wort) that cannot be discontinued during the study.\n18. Current administration of potent CYP3A4 inhibitors (e.g., boceprevir, cobicistat, itraconazole, ketoconazole, clarithromycin, idelalisib, nefazodone, nelfinavir, and ritonavir co-administered with protease inhibitors) that cannot be discontinued during the study.\n19. Medically significant bleeding within 3 months prior to randomization. Tumor invasion\u002Finfiltration of major blood vessels shall be evaluated, and the potential risk of severe hemorrhage due to tumor shrinkage or necrosis will be considered as part of the exclusion assessment.\n20. Ongoing concomitant treatment at a therapeutic dose with anticoagulants such as heparin, thrombin, or factor Xa inhibitors, or with antiplatelet agents (e.g., clopidogrel).\n\n    1. Low-dose aspirin (≤ 100 mg\u002Fday), prophylactic low molecular weight heparin (LMWH), and prophylactic factor Xa inhibitors are acceptable.\n    2. Anticoagulation therapy with LMWH at a therapeutic dose is allowed in participants who have no radiologic evidence of uncontrolled brain metastases, have been on a stable dose of LMWH for at least 2 weeks prior to randomization, and have no history of thromboembolic complications or complications from anticoagulation therapy.\n21. Presence of the following clinically significant diseases:\n\n    1. Unhealed serious active wounds, ulcers, or fractures\n    2. Requirement for hemodialysis or peritoneal dialysis.\n    3. History of solid organ transplantation.\n    4. Ascites with symptoms requiring medical intervention.\n22. Known hypersensitivity to any component of the study intervention (SLC-3010 or axitinib), or their analogs.\n23. Any condition, therapy, laboratory abnormality, or other circumstance (medical history or current evidence) that may expose the patient to risk by participating in the clinical trial, cause confusion in study results, or interfere with the patient's participation throughout the study.\n24. Psychiatric or substance abuse disorders known to interfere with compliance with study requirements.\n25. For female patients only: Pregnant or breastfeeding.","19 Years",{"count":249,"type":22},[85],"\"This study is a phase 2, randomized study to evaluate the efficacy and safety of SLC-3010 in combination with axitinib versus axitinib monotherapy as second-line treatment in patients with locally advanced or metastatic clear cell renal cell carcinoma (ccRCC).\n\nThis study includes a screening period, a treatment period, and a follow-up period. All patients will complete a screening period of up to 28 days. During the treatment period, patients will receive either SLC-3010 in combination with axitinib or axitinib monotherapy. Treatment may continue until the occurrence of unacceptable toxicity related to the study intervention, patient refusal for further participation, or disease progression.\n\nThe patients will be followed up for disease progression and survival for up to 2 years after discontinuation of the study intervention, or until death, consent withdrawal, or the end of this clinical trial, whichever occurs first. For patients who withdraw consent, survival will be followed up via telephone or site visits every 2 months up to death or 12 months after the first administration of the last patient, whichever occurs first, depending on their consent for follow-up.\n\nThis study consists of two parts: Part 1 is the safety run-in phase for SLC-3010 in combination with axitinib, and Part 2 is a randomized phase 2 trial to compare SLC-3010 in combination with axitinib and axitinib monotherapy.",[28,436,437,438],"Neoplasms","Malignant Neoplasms","Malignant Neoplasm of Kidney, Except Renal Pelvis","2026-03-10",{"date":304,"type":36},{"date":442,"type":22},"2026-03",{"date":444,"type":22},"2029-10",{"name":446,"class":43},"Yonsei University",{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":453,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":23,"phases":457,"briefSummary":458,"conditions":459,"keywords":460,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":103},"100610127","phase-2-cemiplimab-or-cemiplimab-and-fianlimab-after-stereotactic-body-radiotherapy-in-clear-cell-renal-cell-carcinoma-100610127","NCT07223541","Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Clear Cell Renal Cell Carcinoma","A Randomized Phase II Trial of Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Oligo-Metastatic Clear Cell Renal Cell Carcinoma","LAG-BOOST","Inclusion Criteria:\n\n* Patient must be \\>= 18 years of age.\n* Patient must have a biopsy\u002Fpathologically (histologically or cytologically) proven diagnosis of clear cell renal cell carcinoma (ccRCC) prior to randomization.\n* Patient must have at least 1 and not more than 5 metastatic lesions measurable by RECIST v1.1, with imaging obtained within 45 days prior to randomization.\n* Patients with untreated brain metastasis measuring \\\u003C2cm in diameter (intracranial RANO-BM measurable disease required) and with minimal neurological symptoms. Patients with treated brain metastasis are eligible for the trial as long as they have had three or fewer brain metastasis without signs of progression of disease on post-treatment MRI of the brain as per RANO for Brain Metastases (RANO-BM) guidelines.\n* Patient must have documentation from a radiation oncologist confirming that all sites (metastases and primary tumor, if present) are amenable to stereotactic body radiation therapy (SBRT).\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n* All patients of childbearing potential must have a serum test within 14 days prior to randomization to rule out pregnancy.\n* Patient must have the ability to understand and the willingness to sign a written informed consent document.\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.\n* Patients must have adequate organ and bone marrow function per protocol.\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial. Testing for HIV is not required for entry onto the study.\n* For patients with history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. If no previous history, testing for HBV is not required for entry onto the study.\n* For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. If no previous history, testing for HCV is not required for entry onto the study.\n* Patients with prior radiation to sites but without evidence of progression will be allowed, however these RT-treated sites will not be treated on study. Patients who have had a prior nephrectomy can be included in the study, patients with prior metastasectomy are also eligible for the study.\n\nExclusion Criteria:\n\n* Patients with untreated brain metastasis \\>2cm, significant neurological deficits and unamenable to surgical resection.\n* Patient with variant histology renal cell carcinoma.\n* Patient with metastasis invading gastrointestinal tract (such as esophagus, stomach, intestines, colon, rectum).\n* Patients with more than 2 liver metastatic lesions, or liver lesions resulting in obstructive jaundice.\n* Patient who have received any prior combination systemic therapy for metastatic RCC (including immune checkpoint inhibitors, tyrosine kinase inhibitors or combinations)\n* Patients who have received any check point inhibitor or immune therapies (i.e. Vaccine or other immune-oncology agent) within the last 12 months. Patients who have previously been treated for non-metastatic RCC with adjuvant pembrolizumab can be included if over 12 months since last dose and they have not had radiographic progression within 12 months from the last dose of pembrolizumab\n* Patients with active autoimmune disease requiring ongoing therapy including systemic treatment with corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications daily. Inhaled steroids and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n* Patients with no more than 1 prior systemic therapy for metastatic disease.\n* Patients with active tuberculosis per protocol.\n* Patients with uncontrolled hypertension (systolic blood pressure \\[BP\\] \\> 190mmHg or diastolic BP \\> 110mmHg).\n* Patients requiring major surgery within 30 days prior to randomization.\n* Patients with any serious (requiring hospital stay or long-term rehab) non-healing wound, ulcer, or bone fracture within 30 days prior to randomization.\n* Patients with any arterial thrombotic (ST elevation myocardial infarction \\[STEMI\\], non-STEMI \\[NSTEMI\\], cerebrovascular accident \\[CVA\\], etc.) events within 180 days prior to randomization.\n* Patients with moderate or severe hepatic impairment (child-Pugh B or C).\n* Patients with untreated pulmonary embolism (PE) or deep-vein thrombosis (DVT) is not allowed.\n* Patients with unstable cardiac arrhythmia within 180 days prior to randomization.\n* Patients with history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, bowel obstruction, or gastric outlet obstruction within 180 days prior to randomization.\n* Patients with history of or active inflammatory bowel disease.\n* Patients with history of connective tissue disease or other disease in which radiation therapy is contraindicated.\n* Patient pregnant or breastfeeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.\n* Patients must not expect to conceive or father children and should use accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 6 months after the last dose of protocol treatment.\n* Patients with a history of myocarditis.\n* Patients with troponin T (TnT) or troponin I (TnI) \\> 2x institutional ULN at baseline per protocol.\n* Patients with history or current evidence of significant (CTCAE grade ≥2) local or systemic infection (e.g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.\n* Patients with active infection requiring therapy.\n* Patients with ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.\n* Patients with uncontrolled infection with HIV, HBV, or HCV infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection per protocol.\n* Patients with known hypersensitivity to the active substances or to any of the excipients.\n* Patients who received a live vaccine within 30 days of planned start of study medication per protocol.\n* Women who are fertile following menarche until becoming postmenopausal or women of childbearing potential (WOCBP\\*), unless permanently sterile must have a negative serum (beta-hCG) at screening per protocol.\n* Pregnant or breastfeeding women.",{"count":456,"type":22},72,[85],"The purpose of this research is to test the safety of PD-1 inhibitor cemiplimab with or without LAG-3 inhibitor fianlimab, and see what effects (good and bad) of cemiplimab either alone or combined with fianlimab has on patients with oligometastatic clear cell renal cell carcinoma after completion of radiation therapy.",[28],[461,462,463],"Stereotactic body radiation therapy (SBRT)","Oligo metastatic","ctDNA","2026-02-26",{"date":466,"type":36},"2026-03-02",{"date":468,"type":36},"2026-01-15",{"date":470,"type":22},"2031-08",{"name":472,"class":43},"University of Oklahoma",{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":339,"phases":4,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":279,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":103},"100611629","tumor-derived-extracellular-vesicles-for-noninvasive-molecular-classification-of-kidney-cancer-100611629","NCT07243067","Tumor-Derived Extracellular Vesicles for Noninvasive Molecular Classification of Kidney Cancer","Inclusion Criteria:\n\n* Urine sample in existing biorepository\n* High-risk renal cell carcinoma (RCC) per American Urological Association (AUA) guidelines\n* Scheduled to undergo nephrectomy\n\nExclusion Criteria:\n\n* Does not meet inclusion criteria",{"count":480,"type":22},300,"This is a correlative (lab-based) study aiming to identify protein markers in urine extracellular vesicles (EVs) that can be used to develop non-invasive molecular tests for patients with renal cell carcinoma (RCC). Aim 1 will use urine collected previously in biorepository. Aim 2 will prospectively collect blood specimens pre and post nephrectomy.",[225,483,484,485,63],"Clear-cell Renal Cell Carcinoma","Papillary Renal Cell Carcinoma","Chromophobe Renal Cell Carcinoma","2026-02-24",{"date":488,"type":36},"2026-02-27",{"date":490,"type":22},"2026-07-15",{"date":492,"type":22},"2027-04-30",{"name":494,"class":43},"Mayo Clinic",{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":23,"phases":504,"briefSummary":505,"conditions":506,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":535},"100534718","phase-1-a-study-of-mgc026-in-participants-with-advanced-solid-tumors-100534718","NCT06242470","A Study of MGC026 in Participants With Advanced Solid Tumors","A Phase 1\u002F1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Adults ≥ 18 years old, able to provide informed consent\n* Adequate performance and laboratory parameters\n* Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an archival tumor sample is not available. Participants with no available archival tissue sample who cannot safely undergo a fresh biopsy as determined by consultation between the sponsor and investigator are eligible\n* Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.\n* Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.\n* Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026.\n* Not pregnant or breastfeeding.\n\nExclusion Criteria:\n\n* Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.\n* Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score \\\u003C 6), or carcinoma in situ.\n* Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on magnetic resonance imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment.\n* Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.\n* Prior treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase payload.\n* Prior autologous or allogeneic stem cell or solid organ transplant.\n* Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders.\n* Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week of first study drug administration.\n* Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction.\n* Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.\n* History of primary immunodeficiency.\n* Major trauma or major surgery within 4 weeks of first study drug administration.\n* Known hypersensitivity to recombinant proteins.",{"count":503,"type":22},250,[56],"The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study.\n\nParticipants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.",[507,368,415,508,509,510,511,512,513,514,515,516,517,518,519,520,28,521,522,523,524,525],"Advanced Solid Tumor","Squamous Cell Carcinoma of Head and Neck","Non Small Cell Lung Cancer","Small-cell Lung Cancer","Bladder Cancer","Sarcoma","Endometrial Cancer","Melanoma","Castration Resistant Prostatic Cancer","Cervical Cancer","Colorectal Cancer","Gastric Cancer","Gastro-esophageal Cancer","Pancreas Cancer","Hepatocellular Carcinoma","Platinum-resistant Ovarian Cancer","Breast Cancer","Ovarian Cancer","Esophageal Squamous Cell Cancer (SCC)","2026-02-03",{"date":528,"type":36},"2026-02-05",{"date":530,"type":36},"2024-03-06",{"date":532,"type":22},"2028-10",{"name":534,"class":74},"MacroGenics",12,{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":543,"enrollmentInfo":544,"targetDuration":4,"studyType":23,"phases":545,"briefSummary":546,"conditions":547,"keywords":549,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":556,"locationsCount":103},"100622900","phase-2-iparomlimab-and-tuvonralimab-ql1706-combination-with-lenvatinib-as-neoadjuvant-therapy-for-ccrcc-100622900","NCT07389629","Iparomlimab and Tuvonralimab (QL1706) Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC","The Efficacy and Safety of Iparomlimab and Tuvonralimab (QL1706) Combined With Lenvatinib as Neoadjuvant Therapy in Renal Cancer With Partial Nephrectomy Indications But High Surgical Risk：A Single Arm, Phase II Clinical Study","Inclusion Criteria:\n\n1. Voluntarily sign a written informed consent form (ICF).\n2. Age at the time of enrollment is \\>= 18 and under 80 years old, with no gender restrictions.\n3. The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or 1;\n4. Expected survival period \\>= 3 months.\n5. Preoperative biopsy pathology confirmed renal clear cell carcinoma or renal cell carcinoma mainly composed of clear cell carcinoma;\n6. ECOG score 0 or 1;\n7. The patient is willing to undergo kidney preservation surgery;\n8. Indications for kidney preservation surgery are available, but limited renal cancer with high difficulty of kidney preservation surgery (stage T1N0M0 or T2N0M0, must meet R.E.N.A.L. score \\>= 10);\n9. At least one measurable lesion (according to mRECIST v1.1 standard) that is suitable for repeated and accurate measurements.\n10. Good organ function, screening laboratory test results meet the following criteria: (1) Hematology (no blood components or cell growth factors are allowed to support treatment within 2 weeks before starting treatment): a. Absolute neutrophil count (ANC) \\>= 1.5 × 10\\^9\u002FL (1500\u002Fmm\\^3); b. Platelet count (PLT) \\>= 100 × 10\\^9\u002FL (100000\u002Fmm\\^3); c. Hemoglobin (HB) \\>= 90 g\u002FL; (2) Liver: a. Serum total bilirubin (TBIL) \\\u003C= 1.5 × ULN; b. Alanine transaminase (ALT) and aspartate transaminase (AST) \\\u003C= 2.5 × ULN; For subjects with liver metastases, AST and ALT are \\\u003C= 5 × ULN, while serum albumin (ALB) is \\>= 28g\u002FL. Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (APTT) are \\\u003C= 1.5 × ULN;\n11. The subjects are willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study.\n\nExclusion Criteria:\n\n1. lymph node metastasis;\n2. The tumor surrounds the renal artery;\n3. Renal vein cancer thrombus;\n4. Diffuse tumor growth, with no clear boundary from normal renal parenchyma;\n5. General poor condition, anesthesia assessment cannot tolerate general anesthesia surgery;\n6. Have serious cardiovascular and cerebrovascular diseases, uncontrollable hypertension and diabetes;\n7. Patients who have long-term use of immunosuppressants after organ transplantation;\n8. Patients who are currently using immunosuppressive drugs;\n9. Patients with clear infection or fever;\n10. Patients with T-cell lymphoma and myeloma;\n11. Patients who have concurrent malignant tumors, are currently undergoing treatment for other benign or malignant tumors, or have a history of other malignant tumors within the past six months;\n12. Metastatic renal cell carcinoma.\n13. Received Chinese herbal medicine or immunomodulatory drugs with anti-tumor indications within 14 days prior to the first use of the investigational drug;\n14. Perform systematic treatment (including thymosin, interferon, interleukin, except for local use to control pleural effusion).\n15. Suffering from active or potentially recurrent autoimmune diseases, except for vitiligo, hair loss, psoriasis, or eczema that do not require systemic treatment; Hypothyroidism caused by autoimmune thyroiditis only requires stable doses of hormone replacement therapy; Type I diabetes requiring only a stable dose of insulin replacement therapy.\n16. Simultaneously enrolled in another clinical study, unless it is an observational, non interventional clinical study or a follow-up period of an interventional study.\n17. Known history of mental illness, drug abuse, alcoholism, or drug use.\n18. Pregnant or lactating women.\n19. Any past or current illness, treatment, or laboratory test abnormalities may confuse the research results, affect the full participation of the subjects in the study, or participation in the study may not be in the best interests of the subjects.","80 Years",{"count":7,"type":22},[85],"Through the combination of aparolitovorelli monoclonal antibody and lenvatinib neoadjuvant therapy, partial nephrectomy can be successfully and safely performed in patients with localized renal cell carcinoma (T1N0M0 or T2N0M0) who have indications for kidney preservation surgery but have difficulty in preserving the kidney (R.E.N.A.L. score \\>= 10).",[548,28,275],"Iparomlimab and Tuvonralimab",[548,28,550],"Neoadjuvant therapy","2026-01-29",{"date":528,"type":36},{"date":554,"type":36},"2025-11-21",{"date":285,"type":22},{"name":557,"class":43},"Sun Yat-sen University",{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":565,"targetDuration":4,"studyType":23,"phases":567,"briefSummary":568,"conditions":569,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":103},"100438490","phase-1-18fpt2385-petct-in-patients-with-renal-cell-carcinoma-100438490","NCT04989959","[18F]PT2385 PET\u002FCT in Patients With Renal Cell Carcinoma","An Exploratory Study of [18F]PT2385 PET\u002FCT in Patients With Renal Cell Carcinoma","Inclusion Criteria:\n\n* Ability to understand and the willingness to sign a written informed consent that includes study interventions (PET\u002FCT and, if cohort 2, mandatory biopsy).\n* Ability to lie still for a 30- to 60-minute PET\u002FCT scan.\n* One of the following:\n\n  1. Cohort 1. Patients with suspected RCC planned for surgery.\n  2. Cohort 2. Patients with metastatic ccRCC or VHL syndrome and RCC. Biopsy is required (planned resection for treatment reasons of a metastatic site is acceptable in lieu of the biopsy).\n  3. Cohort 3. Patients with VHL syndrome with RCC, CNS hemangioblastoma, and\u002For pancreatic neuroendocrine tumor(s) planning to start belzutifan.\n* Patients with liver dysfunction will be considered \"patients of special interest,\" and enrollment is allowed with or without criteria outlined for Cohorts 1-3. Liver dysfunction is defined clinically and is typically supported by abnormalities in imaging or laboratory studies (alanine \u002F aspartate amino-transferase, bilirubin, alkaline phosphatase, or international normalized range (INR) for prothrombin time).\n* Women of child-bearing potential must agree to undergo and have documented a negative pregnancy test on the day of \\[18F\\]PT2385 administration. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or celibate by choice) who meets the following criteria:\n\n  1. Has not undergone a hysterectomy or bilateral oophorectomy; or\n  2. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n\nExclusion Criteria:\n\n* Uncontrolled severe and irreversible intercurrent illness or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.\n* Claustrophobia or other contraindications to PET\u002FCT.\n* Subjects must not weigh more than the maximum weight limit for the table for the PET\u002FCT scanner where the study is being performed (\\>200 kilograms or 440 pounds).\n* For cohort 2 patients, lack of suitable sites for mandatory biopsy. For example, patients with metastatic disease restricted to the lungs that would require percutaneous biopsies with associated risk of bleeding and pneumothorax will be excluded.",{"count":566,"type":22},35,[56],"This is an exploratory study to assess \\[18F\\]PT2385 Positron Emission Tomography\u002FComputed Tomography (PET\u002FCT) in patients with renal cell carcinoma (RCC). This is an open-label, nontherapeutic trial. The main objective is to correlate hypoxia-inducible factor-2alpha (HIF2α) levels as determined by an investigational \\[18F\\]PT2385 PET\u002FCT scan with the levels on subsequently obtained tissue by HIF2α immunohistochemistry (IHC). There will be three cohorts. The first pre-surgical cohort will have \\[18F\\]PT2385 PET\u002FCT prior to nephrectomy. The uptake and retention on Positron Emission Tomography (PET), quantified as standardized uptake value (SUV) max and mean, abbreviated SUV henceforth will be correlated with HIF2α levels by IHC on the primary tumor. The second cohort will comprise patients with metastatic clear cell renal carcinoma (ccRCC). SUV will be correlated with HIF2α levels measured by IHC on a biopsy sample from a metastasis. Both low- and high-avidity sites will be biopsied and tracer uptake correlated with HIF2α IHC. A third cohort will include patients with Von Hippel-Lindau (VHL) syndrome and any of the following disease manifestations - RCC, central nervous system (CNS) hemangioblastoma, and\u002For pancreatic neuroendocrine tumor(s). Investigational imaging will evaluate HIF2α expression within a tumor type and across different tumor types. A biopsy is encouraged but not mandatory for this cohort.",[225,28],"2025-11-26",{"date":572,"type":36},"2025-12-04",{"date":574,"type":36},"2021-08-18",{"date":576,"type":22},"2027-08-18",{"name":578,"class":43},"Orhan Kemal Oz",{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":586,"targetDuration":4,"studyType":23,"phases":588,"briefSummary":589,"conditions":590,"keywords":595,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":620},"100578017","phase-1-a-study-of-the-c-kit-specific-antibody-drug-conjugate-nn3201-for-advanced-andor-metastatic-solid-tumors-known-to-express-c-kit-100578017","NCT06805825","A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and\u002For Metastatic Solid Tumors Known to Express c-Kit","A Phase 1 Dose Escalation and Expansion Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 in Subjects With Advanced and\u002For Metastatic Solid Tumors Known to Express c-Kit","Key Inclusion Criteria:\n\nSubjects must meet the following criteria to be eligible for enrollment into the study:\n\n1. Histologically or cytologically confirmed locally advanced, metastatic, and\u002For unresectable GIST, SCLC, ACC, uveal melanoma, NET ChRCC or ccRCC.\n2. Subjects must have received the following treatment:\n\n   Part A (Dose Escalation):\n\n   i. Treatment with imatinib for GIST (at least one line of therapy with imatinib)\n\n   or\n\n   ii. Progressive\u002Frefractory, ineligible, or intolerant to available standard therapy (or subject declines standard therapy) for c-Kit-associated solid tumors (ACC, uveal melanoma, NET ChRCC or ccRCC)\n\n   Part B (Dose Expansion):\n\n   i. Treatment with imatinib for GIST (at least one line of therapy with imatinib) or\n\n   ii. Progressive\u002Frefractory, ineligible, or intolerant to available standard therapy (or subject declines standard therapy) for Extensive stage SCLC or\n\n   iii. Progressive\u002Frefractory, ineligible, or intolerant to available standard therapy (or subject declines standard therapy) for c-Kit-associated solid tumors (ACC, uveal melanoma, NET or ChRCC or ccRCC).\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Life expectancy ≥ 3 months before starting NN3201 in the opinion of the Investigator.\n5. Age ≥ 18 years.\n6. Laboratory values demonstrating adequately functioning kidney, liver and bone marrow (hematology).\n7. Adequate heart function as measured by ECHO\u002FMUGA scan.\n8. Time between prior anticancer therapy including investigational agents and first dose of NN3201 as below:\n\n   1. Cytotoxic chemotherapy - At least 21 days\n   2. Non-cytotoxic chemotherapy (e.g., small molecule inhibitor) - At least 14 days\n   3. Nitrosoureas - At least 6 weeks\n   4. Monoclonal antibody(ies) - At least 28 days\n   5. Radiotherapy - At least 14 days from local site radiation therapy\n9. Negative Serum\u002Furine pregnancy test (for subjects of childbearing potential)\n10. All subjects of childbearing potential must agree to use contraception throughout the study and for additional 120 days after the last dose of assigned treatment. Subjects must refrain from donating sperm during the same period or Subjects who do not have childbearing potential are confirmed post-menopausal or sterile.\n11. Voluntary agreement to provide written informed consent and have willingness and ability to comply with all aspects of the protocol.\n\nKey Exclusion Criteria:\n\n1. Has received prior therapy with a c-Kit agent (except GIST subjects).\n2. Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms.\n3. A condition requiring systemic treatment with corticosteroids (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to administration of study drugs (inhaled corticosteroids are allowed).\n4. Any prior treatment-related (i.e., chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to Grade ≤ 1 or prior treatment-related toxicities that are clinically unstable and clinically significant at Study Entry, Day -2 to Cycle 1 Day 1.\n5. Major surgery within 30 days before the first dose of study drug treatment in Cycle 1 on Day 1 (port placement for venous access is not considered major surgery).\n6. Significant cardiovascular impairment.\n7. Significant screening electrocardiogram (ECG) abnormalities.\n8. Known active and clinically significant bacterial, fungal, or viral infection.\n9. Uncontrolled hypertension defined as systolic blood pressure ≥ 160mmHg and\u002For diastolic blood pressure ≥ 100mmHg, despite optimal medical management.\n10. Venous thrombosis or pulmonary embolism within the last 3 months prior to the screening.\n11. Ongoing or active infection requiring intravenous treatment with anti-infective therapy or systemic therapy and\u002For any identified active COVID-19 infection.\n12. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the subject's participation in this study.\n13. People who are pregnant or breastfeeding.\n\nOther inclusion and exclusion criteria must also be met to be eligible to participate in this study.",{"count":587,"type":22},67,[56],"This open-label clinical trial will evaluate the safety and tolerability of NN3201 in subjects with advanced and\u002For metastatic solid tumors known to express c-Kit.",[591,510,592,593,594,485,28],"Gastrointestinal Stromal Tumors","Adenoid Cystic Carcinoma","Uveal Melanoma","Neuroendocrine Tumors",[596,597,598,599,600,227,601,602,603,591,510,592,593,604,485,28,605,606,607,608,609,610],"GIST","SCLC","ACC","NET","ChRCC","Novelty Nobility","cKit","c-kit","Neuroendicrine Tumors","advanced GIST","advanced SCLC","advanced ACC","advanced NET","advanced ChRCC","advanced ccRCC","2025-09-18",{"date":613,"type":36},"2025-09-23",{"date":615,"type":36},"2025-02-03",{"date":617,"type":22},"2027-12-31",{"name":619,"class":74},"Novelty Nobility, Inc.",5,{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":625,"acronym":4,"eligibilityCriteria":626,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":627,"targetDuration":4,"studyType":23,"phases":628,"briefSummary":629,"conditions":630,"keywords":4,"overallStatus":279,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":633,"completionDateStruct":635,"leadSponsor":637,"locationsCount":4},"100607385","phase-1-modulation-of-the-bone-immune-microenvironment-following-cabozantinib-treatment-of-bone-metastatic-clear-cell-renal-cell-carcinoma-proof-of-concept-study-100607385","NCT07187869","Modulation of the Bone Immune Microenvironment Following Cabozantinib Treatment of Bone Metastatic Clear Cell Renal Cell Carcinoma: Proof of Concept Study","Inclusion Criteria:\n\nTo be eligible for the study, the subject must meet all of the inclusion and none of the exclusion criteria.\n\n1. Signed Written Informed Consent\n2. Ability to understand and the willingness to sign a written informed consent document.\n3. Participants must have signed and dated an IRB\u002FIEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal participant care.\n4. Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and serial biopsy schedule.\n5. Participants must be willing to consent to PA-17-0577, a protocol led by Dr. Jianjun Gao, that allows for tissue sample collection and analysis\n6. Type of Participant and Target Disease Characteristics\n7. Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid or rhabdoid features\n8. Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC\n9. No prior systemic therapy with nivolumab or cabozantinib or previous systemic treatment for metastatic disease.\n\n   ECOG performance status ≤2 (Karnofsky ≥60%) (See Tables 1 and 2 in section 14 for reference)\n10. Presence of both a bone metastasis and visceral or soft tissue metastatic lesion amenable to biopsies\n11. Patients must have adequate organ and marrow function as defined below:\n\n    * absolute neutrophil count ≥1,000\u002FmcL\n    * platelets ≥100,000\u002FmcL\n    * total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (Except participants with Gilbert Syndrome who must have a total bilirubin \\\u003C 3.0 x ULN)\n    * AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN\n    * GFR ≥30 mL\u002Fmin (using the Cockcroft-Gault formula)\n12. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n13. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n14. Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. Treated CNS metastases are defined as having no ongoing requirement for corticosteroids for at least 2 weeks prior to enrollment and no evidence of progression or hemorrhage after treatment completed at least 4 weeks prior to enrollment clinical examination and brain imaging (MRI or CT).\n15. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n16. Patients are eligible to receive standard of care nivolumab and cabozantinib treatment and must be prescribed this regimen at treating physician's determination.\n17. Age and Reproductive Status\n18. Males and females aged 18 years or greater. Because there is inadequate dosing or adverse event data in patients \\\u003C18 years of age, children are excluded from this study.\n19. The effects of cabozantinib and nivolumab on the developing human fetus are unknown. For this reason and because tyrosine kinase inhibitors and immune checkpoint inhibitors as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation (refer to MDA Policy CLN 1114) and for 4 months after the last dose of cabozantinib and 4 months after the last dose of nivolumab. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n    Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n    * History of hysterectomy or bilateral salpingo-oophorectomy\n    * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n    * History of bilateral tubal ligation or another surgical sterilization procedure.\n    * In addition, females \\\u003C 55 years-of-age must have a serum follicle stimulating (FSH) level \\> 40 mIU\u002FmL to confirm menopause).\n20. Approved methods of birth control are as follows: Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n21. Males who are sexually active with women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of study treatment and 7 months after the last dose of study treatment (ie, 90 days \\[duration of sperm turnover\\] plus the time required for the investigational drug to undergo approximately five half-lives).\n22. Azoospermic males are exempt from contraceptive requirements. WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements, and still must undergo pregnancy testing as described in this section. Investigators shall counsel WOCBP, and male participants who are sexually active with WOCBP, on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise on the use of highly effective methods of contraception which have a failure rate of \\\u003C 1% when used consistently and correctly.\n\nExclusion Criteria:\n\nAny active CNS metastases greater than 0.5cm in size. Participants with treated CNS metastases demonstrated stability for at least 28 days are allowed to enroll.\n\n1. Any impending pathologic fracture or cord compression requiring urgent surgical or site-directed therapy. Participants may be eligible if they undergo initial surgery with tissue collection and have adequately recovered and have received clearance for systemic treatment from orthopedic surgeon or neurosurgery. The tissue collected at the time of initial surgery may be used as the baseline tissue collection. An alternative bone metastasis must be available for biopsy after treatment to be considered eligible.\n2. Any active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n\n   Any condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. Transient short-term use of systemic corticosteroids for allergic conditions (e.g., contrast allergy) is also allowed.\n3. Any tumor invading the GI tract or any evidence of endotracheal or endobronchial tumor within 30 days prior to randomization\n4. Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n5. Known medical condition (e.g., a condition associated with diarrhea or acute diverticulitis, aortic aneurysm, aortic dissection) that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results\n6. History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, bowel obstruction, or gastric outlet obstruction within the past 6 months prior to enrollment\n7. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of cabozantinib (e.g., malabsorptive disorder, ulcerative disease, uncontrolled nausea, vomiting, diarrhea, or small bowel resection)\n8. Serious, non-healing wound or ulcer within 2 weeks prior to study enrollment. May be eligible if cleared by surgical team.\n9. Evidence of active bleeding or bleeding susceptibility; or medically significant hemorrhage within prior 3 months prior to study enrollment. Microscopic hematuria is allowed.\n10. History of cerebrovascular accident (CVA) including transient ischemic attack within the last 6 months prior to enrollment unstable cardiac arrhythmia within 6 months prior to enrollment\n11. Prolongation of the Fridericia corrected QT (QTcF) interval defined as \\> 450 msec for males and \\> 470 msec for females, where QTcF = QT \u002F 3√RR with triplicate measurements\n12. Poorly controlled hypertension (defined as systolic blood pressure (SBP) of \\> 150 mmHg or diastolic blood pressure (DBP) of \\> 90 mmHg), despite antihypertensive therapy\n13. History of any of the following cardiovascular conditions within 3 months of study enrollment: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery by-pass graft surgery, symptomatic peripheral vascular disease, class III or IV congestive heart failure (CHF), as defined by the New York Heart Association (NYHA)\n14. Any radiologic or clinical evidence of pancreatitis within 30 days prior to enrollment\n15. Inability to swallow oral medications or unwillingness or inability to receive IV administration.\n\n    History of allergic reactions attributed to compounds of similar chemical or biologic composition to cabozantinib or other agents used in study.\n16. Pregnant women are excluded from this because cabozantinib is a class D agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cabozantinib breastfeeding should be discontinued if the mother is treated with cabozantinib. The potential risks may also apply to other agents used in this study.\n17. Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.\n18. Active infection requiring systemic treatment. Acute or chronic hepatitis B or C infection or known positive test for tuberculosis infection where there is clinical or radiographic evidence of active mycobacterial infection.\n19. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.\n20. Prior\u002FConcomitant Therapy\n21. Prior treatment with cabozantinib\n22. Concomitant strong CYP3A4 inducers or inhibitors (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's Wort).\n23. Concomitant treatment, in therapeutic doses, with warfarin or warfarin-related agents, direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:\n24. Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n25. Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.\n26. Major surgery (e.g., nephrectomy, laminectomy, open pedicle screw stabilization) less than 4 weeks prior to study enrollment. Procedures not classified as major surgery: percutaneous stabilization, kyphoplasty, and laser interstitial thermal therapy (LITT) and can enroll on study 1-2 weeks after procedure.\n27. Physical and Laboratory Test Findings\n28. WBC \\\u003C 2000\u002FμL\n29. Neutrophils \\\u003C 1500\u002FμL\n30. Platelets \\\u003C 100 x 103\u002FμL\n31. Hemoglobin \\\u003C 9.0 g\u002FdL (support with transfusion is acceptable)\n32. Calculated creatinine clearance \\\u003C 20 mL\u002Fmin (using the Cockcroft-Gault formula)\n33. AST\u002FALT \\> 3.0 x ULN\n34. Total bilirubin \\> 1.5 x ULN (except participants with Gilbert Syndrome who must have a total bilirubin level of \\\u003C 3.0 x ULN)\n35. Urine protein\u002Fcreatinine ratio (UPCR) ≥ 1.0, unless 24-hour urine protein is \\\u003C 1.0 g\n36. INR \\> 1.6\n37. History of allergy or hypersensitivity to study drug components\n38. History of severe hypersensitivity to a monoclonal antibody\n39. Other Exclusion Criteria\n40. Prisoners or participants who are involuntarily incarcerated.\n41. Participants who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness",{"count":317,"type":22},[56],"The goal of our study is to explore how treatments affect the bone immune microenvironment and determine the best treatment options for patients with metastatic kidney cancer to the bone. This could prevent skeletal complications and improve patient outcomes.",[28],"2025-09-16",{"date":613,"type":36},{"date":634,"type":22},"2026-03-31",{"date":636,"type":22},"2029-04-07",{"name":123,"class":43},{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":643,"acronym":644,"eligibilityCriteria":645,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":646,"targetDuration":4,"studyType":23,"phases":648,"briefSummary":649,"conditions":650,"keywords":680,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":710,"lastUpdatePostDateStruct":711,"startDateStruct":713,"completionDateStruct":715,"leadSponsor":717,"locationsCount":719},"100445919","phase-1-a-beta-only-il-2-immunotherapy-study-100445919","NCT05086692","A Beta-only IL-2 ImmunoTherapY Study","A Phase 1\u002F2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors","ABILITY-1","Key Inclusion Criteria:\n\n1. Aged at least 18 years (inclusive at the time of informed consent).\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.\n3. Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n4. Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)\n5. Demonstrated adequate organ function\n6. Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and\u002For MRI.\n7. Life expectancy of ≥ 12 weeks.\n8. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and within 72 hours before the first dose of study drug(s). Women must not be breastfeeding.\n9. Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control.\n\nKey Exclusion Criteria:\n\n1. Last administration of prior antitumor therapy:\n\n   * Prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to start of treatment.\n   * Prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washout is required for palliative radiation (\\\u003C2 weeks of radiotherapy) to non-CNS disease.\n   * Radiation therapy to the lung that is \\> 30Gy within 6 months prior to start of treatment.\n   * Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. Concomitant participation in an observational study must be discussed on a case-by-case basis with the MM for approval.\n2. Has known active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to start of treatment, subject to discussion with MM.\n3. Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers.\n4. Condition requiring long-term systemic treatment with either corticosteroids \\> 10 mg daily prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to start of treatment.\n5. Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.\n6. Severe pulmonary, cardiac or other systemic disease.\n7. Known hepatitis B or C virus infection.\n8. Females who are pregnant or lactating or planning to become pregnant during the study.\n9. Has had an allogeneic tissue\u002Fsolid organ transplant.\n10. Active infection requiring systemic therapy.\n11. Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol\n12. Any other underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug(s) unsafe or obscure the interpretation of toxicity determination or adverse events.\n13. Known severe hypersensitivity to any component of study drug(s).\n14. Inability to comply with study and follow up procedures as judged by the Investigator.",{"count":647,"type":22},115,[56,85],"This is a Phase 1\u002F2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.",[507,651,28,652,653,654,655,518,516,656,511,657,508,658,659,660,661,662,663,664,665,666,667,668,669,670,671,672,673,524,674,675,676,677,678,679,513],"Unresectable Solid Tumor","Triple Negative Breast Cancer","Non-Small Cell Lung Cancer Squamous","Non-Small Cell Lung Cancer Non-squamous","Colorectal Cancer (MSI-H)","Basal Cell Carcinoma","Merkel Cell Carcinoma","Cutaneous Squamous Cell Carcinoma","Pleural Mesothelioma","Esophageal Cancer","Endometrial Carcinoma","Solid Tumor","Solid Tumor, Adult","MSI-H Solid Malignant Tumor","Cancer With A High Tumor Mutational Burden","Epithelial Ovarian Carcinoma","Primary Peritoneal Cancer","Gastroesophageal Junction (GEJ) Cancer","Acral Melanoma","Mucosal Melanoma","Cutaneous Melanoma","DMMR Solid Malignant Tumor","Fallopian Tube Cancer","MSI-H Cancer","DMMR Cancer","Pancreas Adenocarcinoma (MSI-H)","Skin Cancer","Viral Cancer","Cervical Cancers",[681,682,683,684,685,227,686,687,688,689,690,691,692,693,694,695,696,697,698,699,700,701,702,703,704,705,138,706,707,708,709],"IL-2","IL2","Interleukin-2","cancer","metastatic","TNBC","NSCLC","CRC","GEJ","intrahepatic","extrahepatic","MCC","SCCHN","CSCC","Gastroesophageal Junction","advanced","unresectable","MSI-H","dMMR","Microsatellite Instability-High","Mismatch Repair Deficient","PD-1","immunotherapy","anti-PD-1","BCC","HCC","Tumor Mutation Burden High","TMB-H","PDAC","2025-07-03",{"date":712,"type":36},"2025-07-09",{"date":714,"type":36},"2021-08-27",{"date":716,"type":22},"2026-12-30",{"name":718,"class":74},"Medicenna Therapeutics, Inc.",27]