[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"renal-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:renal-cell-carcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,95,0,25,[9,45,97,119,147,167,197,224,251,298,320,341,376,405,462,486,507,527,548,590,612,633,654,682,710],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100494995","transplantation-of-reconstructed-renal-allografts-following-ex-vivo-partial-nephrectomy-100494995",false,"NCT05725421","Transplantation of Reconstructed Renal Allografts Following Ex-Vivo Partial Nephrectomy","Oncologic, Functional and Surgical Outcomes for Patients Undergoing Radical Nephrectomy for Low-Risk Renal Cell Carcinoma and Recipients of Reconstructed Renal Allografts Following Ex-Vivo Partial Nephrectomy","Inclusion Criteria:\n\nFor Donors:\n\n* Adults \\> 50 years\n* Willing and able to understand and sign informed consent\n* Must have high-quality pre-operative cross-sectional imaging (CT or MRI) to determine tumor characteristics and perform parenchymal volume analysis for split renal function\n* Patient who is a candidate for partial nephrectomy for cT1a mass who understands that partial nephrectomy is standard of care for such mass but wishes to be an altruistic kidney donor (primary incentive is altruism) via radical nephrectomy with loss of the entire kidney.\n* Functional considerations:\n\n  o Normal baseline renal function, with eGFR \\> 80 ml\u002Fmin\u002F1.73 m2\n  * No proteinuria on urine dipstick (negative\u002Ftrace considered negative)\n  * Predicted new baseline GFR (NBGFR) following radical nephrectomy would be ≥ 45\n  * NBGFR would be calculated using previously described equation based on split renal function (SFR) and renal functional compensation (RFC)\n  * NBGFR = global GFR x (SRFcontralateral from PVA) x 1.25 (average amount of RFC)2\n* Tumor characteristics on pre-operative cross-sectional imaging:\n\n  * Tumor appears well-encapsulated\n  * Tumor appears amenable to ex-vivo partial nephrectomy with reconstruction that will leave ≥75% of the functioning parenchyma intact and well vascularized\n  * Low risk of complications for the recipient after ex-vivo PN based on surgeon judgment\n  * Tumor is cT1a which is defined as ≤ 4cm and confined\n  * Reconstructed kidney is likely to provide NBGFR for the recipient of \\>30 ml\u002Fmin\u002F1.73 m2. This can be estimated as (global GFR)(SRFipsilateral) x 0.75(estimate that at least 75% of the function will be saved during ex vivo tumor excision and reconstruction). Of note most such kidneys will experience some positive functional compensation but this might be mitigated by a small amount of functional loss related to ischemia. Most studies suggest that this will really be an underestimate of the final GFR in the recipient.\n\nFor Recipients:\n\n* Age \\>60\n* Able to understand and willing to sign informed consent\n* Presence of ESRD or CKD5 with likely progression to ESRD\n* Does not have potential living donor\n* Not likely to receive a more \"ideal\" donor kidney due to significant comorbidities and\u002For age\n\nExclusion Criteria:\n\nFor Donors:\n\n* Known familial RCC syndrome\n* Functional considerations:\n\n  o \\\u003C 50 years of age\n  * Preoperative GFR \\\u003C 80 ml\u002Fmin\u002F1.73 m2\n  * Proteinuria on urine dipstick or urinalysis (≥1+ considered positive)\n  * Predicted new baseline GFR (NBGFR) following radical nephrectomy would be \\\u003C 45\n  * NBGFR would be calculated using previously described equation based on split renal function (SFR) and renal functional compensation (RFC)\n  * NBGFR = global GFR x (SRFcontralateral from PVA) x 1.25 (average amount of RFC)2\n* Comorbidities with risk of deteriorating renal function:\n\n  * Hypertension requiring three or more anti-hypertensives\n  * Diabetes mellitus requiring insulin or with end organ damage\n  * Morbid obesity\n  * History of nephrolithiasis or other\n* Tumor characteristics on pre-operative cross-sectional imaging:\n\n  o Tumor has infiltrative features\n  * Tumor is \\> 4cm (does not meet criteria for cT1a stage)\n  * Regional lymphadenopathy, branch or main renal vein invasion, or other imaging findings suggestive of locally advanced disease\n* Kidney characteristics on pre-operative cross-sectional imaging:\n\n  * More than one renal artery unless can be readily and safely reconstructed\n  * More than one renal vein unless can be readily and safely reconstructed\n  * Duplicated collecting system unless can be readily and safely reconstructed\n* High-risk features on renal mass biopsy (if obtained) or intraoperative pathology\n\n  o Malignant non-RCC pathology\n\n  o Rhabdoid or sarcomatoid differentiation\n\n  o Grade 4\n\n  o Positive or concerning margins during tumor excision\n* Must be deemed appropriate living donor candidate per the standard living donor selection process at the Cleveland Clinic o All altruistic living donors undergo a complete evaluation by medical providers and social workers ensuring that they are appropriate candidates to undergo this procedure. This evaluation includes direct query into any history of psychiatric comorbidities and\u002For substance abuse. If present, this prompts a formal evaluation by psychiatry prior to confirmation of donor candidacy.\n\nFor Recipients:\n\n• Traditional contraindications to kidney transplantation at the Cleveland Clinic would apply, including the following directly from the Transplant Care Pathway:\n\n* Active, untreated bacterial, fungal, or viral infections. Once treated, patients may be reconsidered. Patients with human immunodeficiency virus (HIV)14 or chronic hepatitis15 infections will be evaluated on an individual basis.\n* Active malignancy, except non-melanoma skin cancer and other selected low-grade, low-stage cancers (e.g., bladder, kidney, prostate). The American Society of Transplant (AST) clinical practice guidelines published in 2001 are dated. Improved methods of cancer prognostication are available on a cancer-specific basis.16 An acceptable disease-free waiting period may be needed prior to transplantation depending on the cancer type (stage\u002Fgrade) and treatment modality. Expert opinion from an oncological specialist may be needed to facilitate decisions about wait-listing or performance of a transplant.\n* Medical non-adherence, substance abuse or behaviors leading to a failure to achieve a therapeutic physician\u002Ftransplant team-patient alliance.\n* Life expectancy of less than five years independent of renal disease.\n* Advanced circulatory disease (cardiac, cerebral, peripheral), pulmonary disease or other non-renal conditions such that transplantation would pose a significant risk for morbidity\u002Fmortality.\n* Obesity with body mass index (BMI) \\> 38, or an abdominal wall configuration that in the judgment of the evaluating surgeon poses undue complication risk.\n* Active nicotine abuse (in any form).\n* Poor functional status independent of renal disease.\n* Considering the average waiting times for a deceased donor kidney is more than 3 years, only transplant candidates 72 years or younger will be accepted for evaluation. Suitable candidates may remain on the waiting list up to the age of 75-year-old. They will be delisted if no transplantation has occurred.\n* Cumulative burden of disease defined as multiple medical conditions that on their own may not preclude listing but that in combination are deemed not suitable by the transplant selection committee.","ALL","60 Years",{"count":20,"type":21},5,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is designed to investigate a novel approach to offer more ESRD participants the benefits associated with renal transplantation by increasing the supply of available allografts",[27],"Renal Cell Carcinoma",[29,30,31],"Radical Nephrectomy","Renal Allograft","Ex-Vivo Partial Nephrectomy","NOT_YET_RECRUITING","2026-06-29",{"date":35,"type":36},"2026-06-30","ACTUAL",{"date":38,"type":21},"2026-08",{"date":40,"type":21},"2027-06",{"name":42,"class":43},"Case Comprehensive Cancer Center","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":96},"100602476","destiny-pantumour04-100602476","NCT07124000","DESTINY-PANTUMOUR04","Effectiveness of T-DXd Across HER2-positive Solid Tumors in Patients Who Have Received Prior Systemic Treatment and Have no Satisfactory Alternative Treatment Options: A Hybrid Observational Study","DP-04","Inclusion Criteria:\n\n1. Adults aged ≥18 years\n2. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options as determined by the Investigator (see Exclusion Criterion 1 for excluded solid tumors);\n3. A clinician decision has been made for treatment with T-DXd in accordance with the FDA label;\n4. HER2-positive (IHC 3+) by local testing prior to study enrolment at the time of signed and dated informed consent;\n5. Patients who are willing and able to provide a signed and dated informed consent.\n\nExclusion Criteria:\n\n1. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, NSCLC, adenocarcinoma of the gastric body or gastroesophageal junction or hematological malignancies;\n2. Prior T-DXd therapy;\n3. Patients without a baseline assessment of tumor burden undertaken prior to initiating T-DXd.\n4. Patient is participating in a clinical trial at time of enrolment","18 Years","130 Years",{"count":56,"type":21},100,"OBSERVATIONAL","This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options in a real-world setting in the US",[60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,27,77,78,79,80,81,82,83,84,85],"Adenocarcinoma (NOS)","Anal Cancer","Bladder Cancer","Cervical Cancer","Endometrial Cancer","Esophageal Cancer","Gall Bladder Cancer","Gastrointestinal Stromal Tumour","Head and Neck Cancer","Liver Cancer","Melanoma","Mouth Cancer","Nasopharangeal Cancer","Neuroendocrine, Gastrointestinal Cancer","Ovarian Cancer","Pancreatic Cancer","Prostate Cancer","Salivary Gland Cancer","Sarcoma","Small Cell Lung Cancer","Testicular Cancer","Throat Cancer","Thyroid Cancer","Urethral Cancer","Vaginal Cancer","Vulvar Cancer","RECRUITING","2026-06-26",{"date":33,"type":36},{"date":90,"type":36},"2025-09-18",{"date":92,"type":21},"2028-03-30",{"name":94,"class":95},"AstraZeneca","INDUSTRY",17,{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":44},"100523867","locally-ablative-therapy-in-oligo-progressive-genitourinary-tumors-layover-100523867","NCT06101290","Locally Ablative TherapY in Oligo-ProgressiVe GEnitourinary TumoRs (LAYOVER)","LAYOVER","Inclusion Criteria:\n\n1. Must have one of the following histologically and\u002For biochemically confirmed genitourinary malignancies:\n\n   1. Cohort A: prostate cancer\n   2. Cohort B: urothelial carcinoma\n   3. Cohort C: renal cell carcinoma\n2. Provision of signed and dated informed consent form.\n3. Stated willingness to comply with all study procedures and availability for the duration of the study.\n4. Age ≥18 years at time of consent.\n5. Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.\n6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. \\[Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\\]\n7. ≤ 5 progressing or new metastatic lesions.\n8. All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and\u002F interventional radiologist.\n\nExclusion Criteria:\n\n1. Medical comorbidities precluding locally ablative therapies.\n2. History of treatment related toxicities that limit or prohibit application of locally ablative therapies.\n3. Progressing intracranial lesions.",{"count":105,"type":21},150,[24],"This is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.",[76,109,110,27],"Oligoprogressive","Urothelial Carcinoma","2026-06-25",{"date":35,"type":36},{"date":114,"type":36},"2023-12-05",{"date":116,"type":21},"2035-01-15",{"name":118,"class":43},"University of California, Davis",{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":129,"briefSummary":131,"conditions":132,"keywords":133,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":146},"100610424","phase-3-a-clinical-study-of-belzutifan-and-zanzalintinib-in-people-with-recurrent-kidney-cancer-following-adjuvant-therapy-mk-6482-033-100610424","NCT07227402","A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)","A Phase 3, Randomized, Open-label Study of Belzutifan + Zanzalintinib Versus Cabozantinib in Participants With Advanced RCC Who Experienced Disease Recurrence During or After Prior Adjuvant Anti-PD-1\u002FL1 Therapy (LITESPARK-033)","LITESPARK-033","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a histologically confirmed diagnosis of unresectable, advanced renal cell cancer (RCC) with clear cell component (with or without sarcomatoid features) i.e., Stage IV renal cell cancer per American Joint Committee on Cancer (AJCC) (8th Edition)\n* Has measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)\n* Has disease recurrence during adjuvant anti-programmed cell death 1\u002Fprogrammed cell death ligand 1 (PD-1\u002FL1) therapy or recurrence ≤24 months following the last dose of adjuvant anti-PD-1\u002FL1 therapy\n* Has received no other prior systemic therapy for their RCC except for their adjuvant anti-PD-1\u002FL1 therapy\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, new-onset angina, pulmonary embolism, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability\n* Had deep vein thrombosis within 3 months before randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before randomization\n* Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition or echocardiogram\n* Has had major surgery within 8 weeks before randomization or has not adequately recovered from major surgery or has ongoing surgical complications\n* Has current pneumonitis\u002Finterstitial lung disease\n* Has symptomatic pleural effusion (for example cough, dyspnea, pleuritic chest pain), ascites, or pericardial fluid requiring drainage within 4 weeks prior to randomization\n* Has a gastrointestinal disorder including those associated with a high risk of perforation or fistula formation\n* Has a serious active nonhealing wound\u002Fulcer\u002Fbone fracture\n* Has a requirement for hemodialysis or peritoneal dialysis\n* Has history of human immunodeficiency virus infection\n* Has hepatitis B or hepatitis C virus\n* Has pharmacologically uncompensated, symptomatic hypothyroidism\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention",{"count":128,"type":21},904,[130],"PHASE3","Researchers are looking for more ways to treat advanced renal cell carcinoma (RCC) that is recurrent. Researchers want to learn if recurrent advanced renal cell carcinoma (RCC) responds (gets smaller or goes away) after treatment with belzutifan (MK-6482) and zanzalintinib compared to cabozantinib.\n\nThe goal of this study is to learn if:\n\nPeople who take belzutifan and zanzalintinib live longer overall and without the cancer getting worse than people who take cabozantinib.",[27],[134,135,136,137],"Carcinoma","Renal cell","Belzutifan","Zanzalintinib","2026-06-24",{"date":87,"type":36},{"date":141,"type":36},"2025-11-26",{"date":143,"type":21},"2032-02-27",{"name":145,"class":95},"Merck Sharp & Dohme LLC",114,{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":156,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":163,"leadSponsor":165,"locationsCount":44},"100575328","consolidative-metastasis-and-primary-directed-therapy-mpdt-for-renal-cell-carcinoma-rcc-100575328","NCT06770855","Consolidative Metastasis and Primary Directed Therapy (MPDT) for Renal Cell Carcinoma (RCC)","A Phase II Study of Total Consolidative Metastasis-and-primary Directed Therapy (MPDT) for Renal Cell Carcinoma (RCC).","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of clear cell renal cell carcinoma (mixed histology acceptable but must have clear cell component)\n* Metastatic clear cell RCC with 5 or fewer metastases at enrollment (excluding pulmonary nodules \\\u003C1.0cm)\n* Stable disease or partial response as assessed by investigators following at least 6 months of immune checkpoint blockade-based therapy.\n* Has disease amenable for total consolidative focal therapy (this will be determined by a multidisciplinary team which may include a combination of medical oncologists, urologists, interventional radiologists, and radiation oncologists).\n* ECOG performance status \\\u003C 2\n* Must have archival tissue (slide or Formalin-Fixed Paraffin-Embedded tissue) preceding prior systemic treatment for comparison to tissue from consolidation\n* Consolidation surgery and biopsies are strongly encouraged to be within 42 days +\u002F- 7 days of holding systemic therapy.\n\nExclusion Criteria:\n\n* Subjects who have progressed during the first 6 months of immune checkpoint-blockade based therapy as determined by study investigator.\n* Subjects who have a need for urgent focally directed therapy (i.e. symptomatic brain or spinal metastases). Stable spinal metastases resected and\u002For treated with SBRT in advance of or concurrently with immune checkpoint-blockade based therapy are allowed to participate.\n* Any female of child-bearing potential who has a positive urine pregnancy test within 72 hours before screening. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Participants must be excluded\u002Fdiscontinued from the trial in the event of a positive or borderline positive serum pregnancy test result.",{"count":155,"type":21},23,[24],"This is a non-randomized, open-label phase II study designed to estimate 12-month treatment-free survival rate following total consolidative metastasis-and-primary directed therapy (MPDT) among patients with partial response\u002Fstable disease after at least 6 months of immune checkpoint blockade-based therapy for metastatic clear cell RCC. The investigators hypothesize that patients who undergo total consolidative MPDT followed by systemic therapy discontinuation will have a 12-month treatment-free survival rate of 32% compared to a null hypothesis of 13%",[27],"2026-06-18",{"date":161,"type":36},"2026-06-23",{"date":35,"type":21},{"date":164,"type":21},"2028-09",{"name":166,"class":43},"Abramson Cancer Center at Penn Medicine",{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":17,"minAge":174,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":196},"100437840","phase-2-testing-of-bevacizumab-erlotinib-and-atezolizumab-in-combination-for-advanced-stage-kidney-cancer-100437840","NCT04981509","Testing of Bevacizumab, Erlotinib, and Atezolizumab in Combination for Advanced-Stage Kidney Cancer","A Phase 2 Study of Bevacizumab, Erlotinib and Atezolizumab in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) Associated or Sporadic Papillary Renal Cell Cancer","Inclusion Criteria:\n\n* Patients must have:\n\n  * A diagnosis of HLRCC with a histologic or cytologic confirmation of RCC consistent with this diagnosis (Cohort 1) OR\n  * Cytologically or histologically confirmed sporadic\u002Fnon-HLRCC papillary renal cell carcinoma (presence of papillary component) (Cohort 2)\n* Patients must have advanced RCC with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \\>= 20 mm (\\>= 2 cm) by chest x-ray or as \\>= 10 mm (\\>= 1 cm) with CT scan, MRI, or calipers by clinical exam. To be considered pathologically enlarged and measurable, a lymph node must be \\>= 15 mm (\\>= 1.5 cm) in short axis\n* Patients must have received no more than two prior regimens targeting the VEGF pathway and no prior bevacizumab therapy in the metastatic\u002Fadvanced setting. No prior treatment with PD-1 or PD-L1 inhibitors in the metastatic\u002Fadvanced setting. No prior therapy is required for eligibility\n* Age \\>= 12 years\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 60%)\n* Absolute neutrophil count \\>= 1,000\u002FmcL\n* Platelets \\>= 100,000\u002FmcL\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) (\\\u003C 3 x upper limit of reference range in patients with known\u002Fsuspected Gilbert's disease)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional ULN (or =\\\u003C 5 x upper limit of reference range if considered to be related to liver or bone metastases by the principal investigator \\[PI\\])\n* Alkaline phosphatase =\\\u003C 2.5 x institutional ULN (or =\\\u003C 5 x upper limit of reference range if considered to be related to liver or bone metastases by the PI)\n\n  * Note: For pediatric patients (\\\u003C 18 years of age), ULN for alkaline phosphatase will be defined as 390 IU\u002FL for males and 320 IU\u002FL for females\n* Glomerular filtration rate (GFR) \\>= 30 mL\u002Fmin\u002F1.73 m\\^2\n\n  * Note: For pediatric patients (\\\u003C 18 years of age) the following creatinine thresholds will be utilized. Patients with a creatinine that exceeds this threshold will require further testing with a confirmation of GFR \\>= 40 as determined by either 24-hour urine collection or with radioisotope based nuclear medicine evaluation\n  * Age: 12 to \\\u003C 13 years; Maximum serum creatinine (mg\u002FdL): 1.2 (male); 1.2 (female)\n  * Age: 13 to \\\u003C 16 years; Maximum serum creatinine (mg\u002FdL): 1.5 (male); 1.4 (female)\n  * Age: 16 to \\\u003C 18 years; Maximum serum creatinine (mg\u002FdL): 1.7 (male); 1.4 (female)\n\n    * The threshold creatinine values in this table were derived from the Schwartz formula for estimating GFR, utilizing child length and stature data published by the Centers for Disease Control and Prevention (CDC)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with an 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 treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\u002Frecurrence for \\>= 3 months and the patient no longer requires more than a physiologic dose of steroids\n* Patients does not have a prior or concurrent invasive malignancy; patients are eligible if a prior or concurrent invasive malignancy exists, but the natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Patients with a 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* The effects of study drugs on the developing human fetus are unknown. For this reason, all women and men of childbearing potential must agree to use adequate contraception (including but not limited to abstinence, barrier methods, hormonal contraceptives \\[birth control pills, injections, or implants\\], intrauterine device \\[IUD\\], tubal ligation, vasectomy) prior to study entry and for 6 months after completion of study therapy. 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, and 6 months after completion of study drugs administration\n* Subjects must provide archival tissue block or unstained tumor tissue or be willing to undergo biopsy to collect samples for retrospective central pathology review\n* The ability of subject or parent\u002Fguardian to understand and the willingness to sign a written informed consent document or subjects with impaired decision making capacity (IDMC) if they are represented by a legally authorized representative (LAR)\n\nExclusion Criteria:\n\n* Any prior systemic therapy to treat the patient's kidney cancer within 4 weeks or, if known, 5 half-lives of the prior agent (whichever is shorter) prior to cycle 1 day 1\n* Other prior therapies for kidney cancer: Radiotherapy \\\u003C 2 weeks prior to cycle 1, day 1\n* Major surgical procedure \\\u003C 28 days before cycle 1, day 1. Surgical wounds must be healed prior to starting therapy\n* Patients who have not recovered from adverse events due to prior systemic anti-cancer therapy (i.e., have residual toxicities \\> grade 1 of the Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v\\]5, pre-treatment baseline or to a level permitted under other sections of inclusion\u002Fexclusion criteria) with the exception of alopecia or electrolyte abnormalities that can be corrected to =\\\u003C grade 1 prior to treatment initiation\n* Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1\n* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon \\[IFN\\]-alpha or interleukin \\[IL\\]-2) within 6 weeks prior to cycle 1, day 1\n* Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \\[anti-TNF\\] agents) within 2 weeks prior to cycle 1, day 1\n\n  * Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea or for purposes of pre-medication prior to radiology studies) may be enrolled\n  * The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed\n* Hypercalcemia \\> grade 1 of the CTCAE v5 that is not corrected prior to treatment initiation\n* Patients taking bisphosphonate therapy for symptomatic hypercalcemia. Use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed\n* History of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\n\n  * Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\n  * Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\n  * Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\n\n    * Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\n    * Rash must cover less than 10% of body surface area (BSA)\n    * The disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\n    * No acute exacerbations of the underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation \\[PUVA\\], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)\n* History of idiopathic pulmonary fibrosis, pneumonitis (including drug-induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis. History of radiation pneumonitis in the radiation field (fibrosis) is permitted\n* Patients with untreated latent or active tuberculosis (TB) are excluded\n* Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia\n* Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab\n\n  * NOTE: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines and are not allowed. Influenza vaccination should be given during influenza season only (approximately October to March)\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Poorly controlled hypertension with at least 2 occasions of elevated blood pressure separated by a 24-hour periodd within a week before treatment initiation, despite optimal medical management. (Adults: resting systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg. Pediatric \\[\\\u003C 18 years old\\]: Blood pressure \\[BP\\] \\>= the 95th percentile for age, height, and sex). History of hypertensive crisis or hypertensive encephalopathy\n* Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation\n* History of anaphylactic or severe allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents\n* Patients with myocardial infarction, gastrointestinal (GI) perforation\u002Ffistula, intraabdominal abscess, or cerebrovascular accidents within 6 months before cycle 1, day 1\n* Documented baseline proteinuria \\> 1000 mg\u002Fday on 24-hour urine collection. Only patients with 1+ or greater proteinuria on urinalysis (UA) and a spot urine protein:creatinine ratio of \\> 0.5 will undergo a 24-hour urine collection for quantitation of proteinuria\n* Pregnant women are excluded from this study because study drugs may have 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 study drugs, breastfeeding should be discontinued if the mother is treated with study drugs\n* Serious, non-healing wound or ulcer; bone fracture within 3 months prior to treatment initiation\n* Concomitant therapy with systemic medications or herbal supplements that are known strong inhibitors or inducers of CYP450 3A4, or strong CYP1A2 inducers. To determine the impact of a concomitant drug on CYP enzymes see the FDA-approved product labeling and\u002For tertiary compendia (e.g., Inhibitors and Inducers of Cytochrome P450 Enzymes)\n* Patients who use tobacco or nicotine products and cannot stop their use of these products for the duration of study treatment\n* Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to cycle 1, day 1\n* History of or active hemoptysis within 1 month prior to cycle 1 day 1\n* History of grade \\>= 4 venous thromboembolism\n* History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e., in the absence of therapeutic anticoagulation)\n* Current or recent (\\\u003C 10 days prior to initiation of study treatment) use of aspirin (\\> 325 mg\u002Fday), or clopidogrel (\\> 75 mg\u002Fday)\n\n  * Note: The use of full-dose oral or parenteral anticoagulants for therapeutic purpose is permitted as long as the International Normalized Ratio (INR) and\u002For a partial thromboplastin time (PTT) is within therapeutic limits (according to institution standards) within 7 days prior to initiation of study treatment and the patient has been on a stable dose of anticoagulants for \\>= 2 weeks prior to initiation of study treatment. Prophylactic use of anticoagulants is allowed. However, the use of direct oral anticoagulant therapies such as dabigatran (Pradaxa \\[registered trademark\\]) and rivaroxaban (Xarelto \\[registered trademark\\]) may be used per PI discretion","12 Years",{"count":176,"type":21},65,[178],"PHASE2","This phase II trial studies the effects of combination therapy with bevacizumab, erlotinib, and atezolizumab in treating patients with hereditary leiomyomatosis and kidney cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Bevacizumab is in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumors. This may slow the growth and spread of tumors. Erlotinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein called EGFR that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Combination therapy with bevacizumab, erlotinib, and atezolizumab may stabilize or shrink advanced hereditary leiomyomatosis and kidney cancer.",[181,182,27,183,184,185],"Hereditary Leiomyomatosis and Renal Cell Carcinoma","Papillary Renal Cell Carcinoma","Sporadic Papillary Renal Cell Carcinoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","2026-06-16",{"date":188,"type":36},"2026-06-17",{"date":190,"type":36},"2022-06-10",{"date":192,"type":21},"2027-12-31",{"name":194,"class":195},"National Cancer Institute (NCI)","NIH",13,{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":22,"phases":206,"briefSummary":201,"conditions":208,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":196},"100601788","phase-1-a-study-to-investigate-safety-of-azd6750-in-adult-participants-with-select-advanced-or-metastatic-solid-tumors-100601788","NCT07115043","A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors","A Phase I\u002FII Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors","Inclusion criteria:\n\n* Participant ≥ 18 year\n* ECOG PS of 0 to 1\n* Provision of 'archival' tumor specimen\n* At least one measurable lesion according to RECIST v1.1,\n* Minimum life expectancy of 12 weeks\n* Adequate and stable cardiac function\n* Adequate bone marrow, liver and kidney function\n* Body weight ≥ 35 kg\n* Capable of giving signed informed consent\n\nModule 1 specific inclusion criteria:\n\n• Participants with locally advanced or metastatic select solid tumors (MM, Squamous cell carcinoma of skin, MCC, NSCLC, Head and neck squamous cell carcinoma, Gastric cancer\u002Fgastroesophaegeal junction cancer, RCC, HGSOC, Triple negative breast cancer) who have received adequate SoC\n\nModule 2 specific inclusion criteria:\n\n* Participants with Stage IV NSCLC Dose Escalation\u002FBackfills\n\n  1. Have received at least one prior regimen in metastatic setting (2L+ NSCLC). Participants with actionable tumor alterations should have received targeted therapy if locally available OR\n  2. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.\n\n     Dose Expansion\n\n  \u003C!-- -->\n\n  1. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.\n\n     Exclusion criteria:\n* Any evidence of:\n\nSevere or uncontrolled systemic diseases including respiratory, cardiac or tumor-related conditions\n\n* History or planned organ or allogeneic stem cell transplantation.\n* Active or prior documented autoimmune or inflammatory disorders, within the past 3 years\n* Any prior toxicities that led to permanent discontinuation of prior immunotherapy\n* Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy\n* Brain metastases unless treated, asymptomatic, stable, and not requiring continuous corticosteroids\n* Acute untreated or symptomatic malignant spinal cord compression, or a history of leptomeningeal carcinomatosis.\n* Active uncontrolled or chronic infection of hepatitis B, hepatitis C\n* Prior history of Grade ≥ 3 non-infectious pneumonitis.\n* Participant requires chronic immunosuppressive therapy (including steroids \\> 10 mg prednisone\u002Fday or equivalent).\n* Receipt of live attenuated vaccine within 30 days.\n\nModule 2 specific exclusion criteria:\n\n* Previous treatment with anti-TIGIT therapy\n* 1L NSCLC participants with genetic alteration such as EGFR that has a targeted therapy in 1L as per local SoC",{"count":205,"type":21},60,[207,178],"PHASE1",[70,209,210,27,211,212,213,214,215],"Non-small Cell Lung Cancer","Squamous Cell Carcinoma (Skin)","Merkel Cell Carcinoma","Triple Negative Breast Cancer","Head and Neck Squamous Cell Carcinoma","Gastric Cancer\u002FGastroesophageal Junction Cancer","High Grade Serous Ovarian Carcinoma","2026-06-10",{"date":218,"type":36},"2026-06-11",{"date":220,"type":36},"2025-07-29",{"date":222,"type":21},"2029-10-02",{"name":94,"class":95},{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":22,"phases":233,"briefSummary":234,"conditions":235,"keywords":236,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":250},"100607986","phase-1-a-first-in-human-study-of-bms-986506-in-participants-with-advanced-clear-cell-renal-cell-carcinoma-ccrcc-100607986","NCT07195682","A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)","A Phase 1\u002F1b Open-label, Multi-center Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)","Inclusion Criteria:\n\n* Participants must have histologically confirmed diagnosis of locally advanced or metastatic ccRCC.\n* For part 1: Participants must have already had at least two different treatment plans in the past, including immunotherapy and a targeted therapy.\n* For part 2: Participants must have had at least one standard treatment plan that included both a PD-1\u002FL1 inhibitor and a VEGF-TKI (either together or one after the other).\n* Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n\nExclusion Criteria:\n\n* Participants with Inability to administer and\u002For tolerate oral medication without chewing, breaking, crushing, or otherwise altering the product dosage form.\n* For Part 2A: Participants who have received more than 3 prior systemic regimens for locally advanced or metastatic ccRCC including prior treatment with HIF2a inhibitors.\n* Participants who have hypoxia as defined by a pulse oximeter reading \\\u003C 92% at rest or requires intermittent or chronic supplemental oxygen.\n* Participants who have received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) within 28 days prior to the first dose of study intervention.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":232,"type":21},125,[207],"This is a first-in-human study of BMS-986506 in participants with advanced Clear Cell Renal Cell Carcinoma (ccRCC). The primary objective of this study is to find out if BMS-986506 is safe and can be tolerated when taken alone by participants with ccRCC.",[27],[237,238,239,240],"Metastatic clear cell renal cell carcinoma","Advanced clear cell renal cell carcinoma","ccRCC","Kidney cancer","2026-06-08",{"date":243,"type":36},"2026-06-09",{"date":245,"type":36},"2026-01-15",{"date":247,"type":21},"2031-04-03",{"name":249,"class":95},"Bristol-Myers Squibb",9,{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":22,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":44},"100536473","phase-2-comparison-of-in-home-versus-in-clinic-administration-of-subcutaneous-nivolumab-through-cancer-care-connected-access-and-remote-expertise-beyond-walls-ccbw-program-100536473","NCT06265285","Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program","MC230716 Pilot Single-Arm, Pragmatic Trial Of In-Home Versus In-Clinic Subcutaneous Nivolumab Administration Through Cancer CARE (Connected Access And Remote Expertise) Beyond Walls (CCBW) Program","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically confirmed malignancies for which treatment with intravenous nivolumab is currently Food and Drug Administration (FDA) approved and who are recommended to initiate a new treatment regimen with single agent intravenous (IV) nivolumab by their treating oncologist for any of the indications outlined below and who are willing to switch to subcutaneous nivolumab. Additionally, patients who are currently receiving single-agent IV nivolumab are eligible, provided they transition to subcutaneous nivolumab on-study, with their first subcutaneous (subQ) dose administered on cycle 1, day 1 of the study.\n\n  * Single agent nivolumab administered in the adjuvant setting for one of the following indications:\n\n    * Completely resected stage IIB\u002FC, III or IV melanoma\n    * Urothelial carcinoma status post radical resection and have a high risk of recurrence\n    * Completely resected esophageal or gastroesophageal junction carcinoma with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT)\n  * Single agent nivolumab for advanced\u002Fmetastatic cancer for one or more of the following indications:\n\n    * Renal cell carcinoma (RCC) patients who have received prior anti-angiogenic therapy\n    * Non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy (Note: patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab)\n    * Unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy\n    * Unresectable or metastatic cutaneous melanoma\n    * Locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy\n    * Unresectable or metastatic urothelial carcinoma, as first-line treatment in combination with cisplatin and gemcitabine.\n\n      * Subcutaneous nivolumab to be initiated as monotherapy following six cycles of cisplatin + gemcitabine\n    * Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy\n    * Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan\n  * Patients transitioning to maintenance nivolumab and who are willing to switch to subcutaneous nivolumab after completion of Ipilimumab and nivolumab combination therapy for one or more of the indications listed below (Note: patients who discontinue ipilimumab for immune-related toxicities, but are deemed to be eligible to continue on single agent nivolumab maintenance by their treating oncologist are eligible):\n\n    * First-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC)\n    * Unresectable or metastatic cutaneous melanoma\n    * Hepatocellular carcinoma (HCC) previously treated with sorafenib\n    * Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan\n  * Single agent nivolumab administered in the adjuvant setting following neoadjuvant nivolumab with platinum doublet chemotherapy for patients with resectable (tumors ≥ 4 cm and\u002For node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements\n* Patients have recovered from the effects of any previous chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy, and\u002For surgery (i.e., residual toxicity no worse than grade 1 \\[grade 2 treatment-associated peripheral neuropathy, grade 2 fatigue and\u002For any grade of alopecia are acceptable assuming all other inclusion criteria are met\\]) before registration\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* Aspartate transaminase (AST) values ≤ 3 × the upper limit of normal (ULN). For patients with documented baseline liver metastasis, the following limits will apply: 5 × ULN for transaminase\n* Alanine transaminase (ALT) values ≤ 3 x the upper limit of normal (ULN). For patients with documented baseline liver metastasis, the following limits will apply: 5 x ULN for transaminase\n* Serum total bilirubin values of ≤ 1.5 x ULN ( ≤ 2 x ULN for patients with known Gilbert's syndrome). For patients with documented baseline liver metastasis, the following limits will apply: 2 x ULN for bilirubin\n* Absolute neutrophil count (ANC) of ≥ 1500\u002FμL\n* Platelet count of ≥ 100,000\u002FμL\n* Hemoglobin of ≥ 9 g\u002FdL (patients may be transfused to this level, if necessary, but transfusion must occur \\> 1 week prior to registration)\n* Serum creatinine ≤ 2.0 x the ULN for the reference laboratory or a calculated creatinine clearance of ≥ 30 mL\u002Fmin by the Cockcroft-Gault Equation measured ≤ 7 days prior to registration\n* Patients are residing ≤ 35 miles of clinic (hub) or within the area serviced by supplier and paramedic network\n* Residence has Wi-Fi to enable a reliable connection with the remote command center\n* Patients have signed Informed Consent Form (ICF)\n* Patients are willing and able to comply with the study protocol in the investigator's judgment\n* Patients are able and willing to complete study questionnaire(s) by themselves or with assistance\n* Women of childbearing potential (WOCBP) must:\n\n  * Have a negative pregnancy test (serum or urine) ≤ 3 days before the first dose of study drug\n  * Be agreeable to use a contraceptive method that is highly effective during the intervention period and for at least 5 months after the last dose and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same time period\n\nExclusion Criteria:\n\n* Patients receiving any other investigational or standard of care agent which would be considered as a treatment for the primary neoplasm and is not part of the eligible treatment regimen\n* Patients requiring 24\u002F7 assistance with activities of daily living (ADLs)\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Myocardial infarction ≤ 6 months\n  * Wound healing disorder\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Patients with any severe infection ≤ 4 weeks prior to registration including, but not limited to, hospitalization for complications of infections\n* Patients with an active, known or suspected autoimmune disease. Patients 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. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with celiac disease controlled with diet modification are not excluded\n* Patients with a condition requiring systemic treatment with either corticosteroids ( \\> 10 mg daily prednisone equivalent) ≤ 14 days or other immunosuppressive medications ≤ 30 days prior to registration. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active ≤ 2 years prior to registration (i.e., participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization\u002Ftreatment assignment and the patient has no evidence of disease). Participants with history of prior early stage basal\u002Fsquamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are also eligible\n* Patients have undergone prior solid organ and\u002For non-autologous hematopoietic stem cell or bone marrow transplant\n* Patients with active brain metastases or leptomeningeal metastases, aside from the exceptions below. Participants with brain metastases are eligible if they are:\n\n  * Asymptomatic\n  * Have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the central nervous system \\[CNS\\] treatment), and\n  * There is no MRI evidence of progression for at least 4 weeks after CNS directed therapy is complete and ≤ 28 days prior to registration\n  * In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to registration\n* Participants with brain disease treated with whole brain radiation\n* Anticipation of the need for major surgery during the course of study treatment\n* Participants who are pregnant or breastfeeding\n* Treatment with any live attenuated vaccines ≤ 30 days of registration (vaccines that are not live attenuated are allowed, including COVID-19 vaccine)\n* Known human deficiency virus (HIV) positive with an AIDS defining opportunistic infection within the last year, or a current CD4 count \\\u003C 350 cells\u002FuL, aside from the exceptions below. Participants with HIV are eligible if:\n\n  * They have received antiviral therapy (ART) for at least 4 weeks prior to treatment assignment as clinically indicated while enrolled in the study\n  * They continue on ART as clinically indicated while enrolled on study\n  * CD4 counts and viral load are monitored per standard of care by a local healthcare provider\n* History of allergy or hypersensitivity to study drug components\n* Any positive test result for hepatitis B virus (HBV) indicating presence of virus (e.g., hepatitis B surface antigen \\[HBsAg, Australia antigen\\]) positive\n* Any positive test result for hepatitis C virus (HCV) indicating presence of active viral replication (detectable HCV-ribonucleic acid \\[RNA\\]). Note: Participants with positive HCV antibody and an undetectable HCV RNA are eligible to enroll",{"count":259,"type":21},50,[178],"This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access to transport. Studies have shown that cancer patients often feel more comfortable and secure being cared for in their own home environments. SC nivolumab in-home treatment may be safe, tolerable and\u002For effective when compared to in-clinic treatment and may reduce the burden of cancer and improve the quality of life in cancer patients.",[263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,27,184,285,286,185,287,288,110,289],"Advanced Esophageal Squamous Cell Carcinoma","Advanced Renal Cell Carcinoma","Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage IIB Cutaneous Melanoma AJCC v8","Clinical Stage IIC Cutaneous Melanoma AJCC v8","Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8","Esophageal Carcinoma","Gastroesophageal Junction Adenocarcinoma","Hepatocellular Carcinoma","Locally Advanced Urothelial Carcinoma","Lung Non-Small Cell Carcinoma","Malignant Solid Neoplasm","Metastatic Colorectal Carcinoma","Metastatic Cutaneous Melanoma","Metastatic Esophageal Squamous Cell Carcinoma","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Urothelial Carcinoma","Recurrent Esophageal Squamous Cell Carcinoma","Recurrent Head and Neck Squamous Cell Carcinoma","Stage IV Colorectal Cancer AJCC v8","Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8","Unresectable Cutaneous Melanoma","Unresectable Esophageal Squamous Cell Carcinoma","Unresectable Urothelial Carcinoma","2026-06-05",{"date":243,"type":36},{"date":293,"type":36},"2024-04-30",{"date":295,"type":21},"2026-12-31",{"name":297,"class":43},"Mayo Clinic",{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":17,"minAge":305,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":22,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":314,"completionDateStruct":315,"leadSponsor":317,"locationsCount":44},"100615827","phase-1-gcar1-a-chimeric-antigen-receptor-car-t-cell-therapy-for-relapsedrefractory-gpnmb-expressing-solid-tumours-100615827","NCT07297667","GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed\u002FRefractory GPNMB-Expressing Solid Tumours","A Phase I Study of GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Participants With Selected Relapsed\u002FRefractory GPNMB-Expressing Solid Tumours","Inclusion Criteria:\n\n* Archival tumour specimen must be positive for GPNMB with high expression by immunohistochemistry (central laboratory testing).\n* Histologically and\u002For cytologically confirmed diagnosis of one of the following tumours that is advanced\u002F metastatic\u002F recurrent or unresectable, for which no curative therapy exists.\n* alveolar soft part sarcoma\n* renal cell carcinoma (excluding clear cell)\n* triple negative breast cancer (ER, PR and HER-2 negative as defined by ASCO\u002FCAP criteria)\n* Must have a formalin fixed paraffin embedded tissue block (from primary or metastatic tumour) available and must have provided informed consent for the release of the block.\n* Presence of radiologically documented disease.\n* Measurable disease as defined by RECIST 1.1.\n* ASPS participants ≥ 15 years of age.\n* TNBC and RCC participants ≥ 18 years of age.\n* ECOG performance status of 0 or 1 or Karnofsky or Lansky \\> 60.\n* Anticipated life expectancy of ≥ 6 months.\n* Must have received prior systemic therapy as shown below;\n* ASPS - completed all systemic therapy available that has been shown to improve survival (unless contraindicated).\n* TNBC\n\n  1. Progressive disease following at least one line of systemic treatment for metastatic disease which must include an ADC (all participants) and an ICI (participants whose tumours express PD-L1).\n  2. ≤3 lines of treatment for metastatic disease.\n  3. Must have had at least 1 prior line of cytotoxic chemotherapy for breast cancer, in any setting, which must have included an anthracycline and a taxane (unless contraindicated).\n* RCC - must have progressive disease following at least one line of systemic treatment for metastatic disease that must have included an ICI and a VEGFR targeted agent (unless contraindicated).\n* Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior therapies.\n* Adequate washout must be followed per protocol.\n* Previous major surgery is permitted ≥21 days prior to enrollment\n* Prior external beam radiation is permitted ≥28 prior to enrollment. Concurrent radiotherapy is not permitted.\n* Adequate hematologic and biochemical parameters.\n* Consent and assent, when applicable, must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant or their parent\u002F legal guardian (if applicable) must sign a consent form prior to screening onto the trial to document their willingness to participate.\n* Fit for leukapheresis and has adequate venous access for cell collection.\n* Must be accessible for treatment and follow up at the participating centre for a minimum of 12 months or for as long as is deemed necessary by the treating physician.\n* Participants of childbearing potential must have agreed to use a highly effective contraceptive method.\n\nExclusion criteria\n\n* Participants on active anticancer therapy for other advanced or metastatic malignancies.\n* Concurrent treatment with other anti-cancer therapy\n* Prior therapy with a gene therapy product or any adoptive T cell therapy or prior GPNMB targeting therapy.\n* Live attenuated vaccination administered within 30 days prior to or planned within 30 days after GCAR1 therapy.\n* Primary immunodeficiency or history of severe autoimmune disease (including: Crohn's disease, rheumatoid arthritis, systemic lupus) requiring immunosuppressive agents\u002F systemic disease modifying agents within 2 years of enrollment.\n* Active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the participant to be managed according to the protocol including but not limited to:\n* Hepatitis B or C virus (HBV or HCV). For participants with previous HBV or HCV infection who are currently on treatment, they are eligible if they have an undetectable viral load via quantitative PCR and\u002For nucleic acid testing\n* HIV positive by serology and PCR\n* Uncontrolled fungal, bacterial, viral or other infection\n* Current infection with HTLV-1\n* Tuberculosis\n* Syphilis\n* West Nile Virus\n* Untreated and\u002For uncontrolled cardiovascular conditions and\u002For symptomatic cardiac dysfunction (including cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects) or unstable angina congestive heart failure or myocardial infarction within the previous year.\n* Known sensitivity or allergy to fludarabine, cyclophosphamide or any of their components, or to GCAR1 or any of its components.\n* Active intracerebral metastases or leptomeningeal disease. Participants who have received definitive treatment, are clinically stable and do not require corticosteroids are eligible to participate in the trial.\n* Pregnant or breastfeeding women.","15 Years",{"count":307,"type":21},30,[207],"Only enrolling in Canada.\n\nThe purpose of this study is to identify the highest dose of GCAR1, a chimeric antigen receptor (CAR-T) cell therapy, that can be tolerated without causing very severe side effects, and to see what effects GCAR1 has on selected cancers",[311,27,212],"Alveolar Soft Part Sarcoma","2026-06-04",{"date":241,"type":36},{"date":35,"type":21},{"date":316,"type":21},"2033-09-01",{"name":318,"class":319},"Canadian Cancer Trials Group","NETWORK",{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":330,"conditions":331,"keywords":332,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":334,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":44},"100594330","role-of-ttv-during-first-line-immunotherapy-treatment-in-patients-with-renal-cell-carcinoma-100594330","NCT07018037","Role of TTV During First-line Immunotherapy Treatment in Patients With Renal Cell Carcinoma","Pilot Study to Describe the Role of TTV During First-line Immunotherapy Treatment in Patients With Renal Cell Carcinoma","TTV ccRCC","Inclusion Criteria:\n\n* Patients over 18 years of age;\n* Histological diagnosis of clear cell renal cell carcinoma;\n* Evidence of advanced or metastatic disease;\n* Patients diagnosed with metastatic clear cell renal cell carcinoma about to start first-line immunotherapy (ICI + ICI or ICI + TKI);\n* Patients able to comply with the study procedures.\n* Patients who give written informed consent personally or through a witness (study participation and data processing), before any study-specific procedure is started.\n\nExclusion Criteria:\n\n* Previous neoplasms;\n* Previous antineoplastic treatments;\n* Previous steroid treatments;\n* Active viral infections (e.g., HCV, HIV, etc.);\n* Lack of autonomy in adhering to study procedures.",{"count":329,"type":21},20,"The aim of this project is to descriptively explore the trend of torquetenovirus viral load TTV during therapy with immune checkpoint inhibitor ICI in these patients, to evaluate a possible role of this virus as a biomarker of response.",[27],[333],"Torquetenovirus (TVV)",{"date":290,"type":36},{"date":336,"type":36},"2025-01-29",{"date":338,"type":21},"2027-01-29",{"name":340,"class":43},"Regina Elena Cancer Institute",{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":348,"enrollmentInfo":349,"targetDuration":4,"studyType":22,"phases":351,"briefSummary":352,"conditions":353,"keywords":358,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":4},"100639777","phase-1-a-first-in-human-study-of-hh160-in-patients-with-advanced-solid-tumors-100639777","NCT07623369","A First-in-Human Study of HH160 in Patients With Advanced Solid Tumors","An Open-Label, Multicenter, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Antitumor Activity of HH160 in Patients With Advanced Solid Tumors","Key Inclusion Criteria\n\n1. Adults aged 18 to 75 years with signed informed consent.\n2. Histologically or cytologically confirmed advanced solid tumors meeting phase-specific disease requirements.\n3. At least 1 measurable lesion per RECIST v1.1.\n4. Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status of 0 or 1 with life expectancy ≥ 12 weeks.\n5. Adequate organ function based on protocol-specified laboratory criteria.\n\nKey Exclusion Criteria\n\n1. Active leptomeningeal disease or uncontrolled\u002Funtreated brain metastases.\n2. History of severe hypersensitivity reactions to monoclonal antibodies, bispecific antibodies, trispecific antibodies, or study drug components.\n3. Other malignancy within 3 years prior to first dose, except specified curatively treated cancers.\n4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage.\n5. Significant bleeding risk, severe coagulopathy, gastrointestinal hemorrhage, or recent pulmonary hemorrhage\u002Fhemoptysis.\n\nNOTE: Other eligibility criteria may apply.","75 Years",{"count":350,"type":21},56,[207],"This study is evaluating the safety, side effects, how the body processes HH160, and its early anticancer activity when given alone or with other cancer treatments in participants with advanced solid tumors. The study will also identify the recommended dose for future studies. The trial includes two phases and is expected to last about 4 years, with treatment and follow-up lasting approximately 6-12 months each.",[354,209,274,355,213,27,64,63,356,212,110,357],"Solid Tumor","Colorectal Cancer","Small-cell Lung Cancer","Gastroesophageal Adenocarcinoma",[359,360,209,361,274,362,355,363,364,213,27,365,64,63,356,212,366,110,357,74],"HH160","PD-1×CTLA-4×VEGF-A Antibody","NSCLC","HCC","CRC","GEA","RCC","TNBC","2026-05-29",{"date":369,"type":36},"2026-06-03",{"date":371,"type":21},"2026-06",{"date":373,"type":21},"2028-08",{"name":375,"class":95},"Huahui Health",{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":22,"phases":384,"briefSummary":385,"conditions":386,"keywords":393,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":404},"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":307,"type":21},[207],"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.",[387,27,365,388,239,389,390,391,392],"Clear Cell Renal Cell Carcinoma","Clear Cell Renal Cell Carcinoma Metastatic","VHL-Associated Clear Cell Renal Cell Carcinoma","VHL-Associated Renal Cell Carcinoma","Kidney Cancer Metastatic","Kidney Cancers",[239,27,387,394,395],"VHL","Kidney Cancer",{"date":397,"type":36},"2026-06-02",{"date":399,"type":36},"2025-12-19",{"date":401,"type":21},"2027-09",{"name":403,"class":95},"Neomorph, Inc",10,{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":412,"targetDuration":4,"studyType":22,"phases":414,"briefSummary":415,"conditions":416,"keywords":420,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":461},"100527382","phase-1-a-phase-1-dose-escalation-study-of-225ac-fpi-2068-in-adult-patients-with-advanced-solid-tumours-100527382","NCT06147037","A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours","A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours","Key Inclusion Criteria:\n\nHistologically and\u002For cytologically confirmed solid tumor that is metastatic, locally advanced, recurrent or inoperable.\n\nDisease that has progressed despite prior treatment, and for which additional effective standard therapy is not available or is contraindicated, not tolerable, or the participant refuses standard therapy.\n\nMeasurable disease as defined by RECIST Version 1.1\n\nECOG Performance status of 0 or 1\n\nAdequate organ function\n\nKey Exclusion Criteria:\n\nPrevious treatment with any systemic radiopharmaceutical\n\nPrior anti-cancer therapy unless adequate washout and recovery from toxicities\n\nContraindications to or inability to perform the imaging procedures required in this study\n\nRadiation therapy (RT) within 28 days prior to the first dose of \\[111In\\]-FPI-2107\n\nUncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (≥ once per month)\n\nPatients with known CNS metastatic disease unless treated and stable",{"count":413,"type":21},70,[207],"This is a first-in-human, Phase 1, non-randomized, multicenter, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of \\[225Ac\\]-FPI-2068, \\[111In\\]-FPI-2107, and FPI-2053 in metastatic and\u002For recurrent solid tumors (HNSCC, NSCLC, mCRC, PDAC, GC, RCC).",[417,278,213,209,418,419,27],"Advanced Solid Tumor","Pancreatic Ductal Adenocarcinoma","Gastric Cancer",[421,422,423,424,425,426,427,428,429,430,431,432,433,434,435,436,437,438,439,440,441,442,443,444,445,446,361,447,448,365,449,450,451,452],"FPI-2068","FPI-2107","FPI-2053","Actinium-225","225Ac","Indium-111","111In","Solid tumors","Targeted alpha therapy","TAT","Epidermal growth factor receptor","EGFR","Mesenchymal-epithelial transition factor","cMET","Bispecific antibody","Radioimmuno-SPECT agent","Radioimmuno-therapeutic agent","Monoclonal antibody","Bifunctional chelating agent","Radiopharmaceutical therapy","Alpha particle emitter","Directed bispecific monovalent antibody","bsAb","Bifunctional chelate","mCRC","HNSCC","PDAC","GC","RLT","Radioligand Therapy","EGFRm","EGFRwt","2026-05-22",{"date":455,"type":36},"2026-05-26",{"date":457,"type":36},"2024-07-31",{"date":459,"type":21},"2028-05-12",{"name":94,"class":95},15,{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":469,"enrollmentInfo":470,"targetDuration":4,"studyType":22,"phases":472,"briefSummary":473,"conditions":474,"keywords":475,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":485},"100596780","phase-1-substudy-03c-a-study-of-combination-therapies-in-participants-with-renal-cell-carcinoma-with-recurrent-disease-during-or-after-anti-pd-l1-therapy-mk-3475-03ckeymaker-u03-100596780","NCT07049926","Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (MK-3475-03C\u002FKEYMAKER-U03)","A Phase 1b\u002F2 Study of Immune and Targeted Combination Therapies in Participants With RCC (KEYMAKER-U03): Substudy 03C in Participants With Recurrent Disease During or After Anti-PD-(L)1 Adjuvant Therapy","The main inclusion criteria include but are not limited to the following:\n\n* Has a histologically confirmed diagnosis of unresectable locally advanced\u002Fmetastatic renal cell carcinoma (RCC) with clear cell component\n* Has received no other prior systemic therapy for treatment of advanced\u002Fmetastatic clear cell renal cell carcinoma (ccRCC) except for adjuvant programmed cell death ligand 1 (PD-(L)1) therapy\n* Has disease recurrence during adjuvant anti- PD-(L)1 therapy or ≤24 months following the last dose of adjuvant anti-PD-(L)1 therapy\n* Is able to swallow oral medication\n* Submits an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated\n* Participants receiving bone resorptive therapy (must have therapy initiated at least 2 weeks before allocation\u002Frandomization)\n* Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤140\u002F90 mm Hg with no change in antihypertensive medications within 1 week before allocation\u002Frandomization\n* Has adequate organ function\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has clinically significant hematuria, hematemesis, or hemoptysis of (\\>2.5 mL) of red blood, or other history of significant bleeding\n* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention\n* Has deep vein thrombosis within 3 months before allocation\u002Frandomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before allocation\u002Frandomization\n* Has history of idiopathic pulmonary fibrosis, organizing pneumonia, or evidence of active pneumonitis\n* Has serious wound, ulcer or bone fracture or has had major surgery within 8 weeks before first dose of study intervention\n* Has symptomatic pleural effusion (for example cough, dyspnea, pleuritic chest pain), ascites, or pericardial fluid requiring drainage in the last 4 weeks before allocation\u002Frandomization\n* Has gastrointestinal (GI) disorders, including those associated with a high risk of perforation or fistula formation\n* Has malabsorption due to prior GI surgery or GI disease\n* Has moderate to severe hepatic impairment\n* Has received colony-stimulating factors within 28 days prior to intervention allocation\u002Frandomization\n* Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids\n* Is currently receiving strong inhibitors of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study\n* Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention\n* Is currently receiving anticoagulants or platelet inhibitors that cannot be discontinued for the duration of the study\n* Have been previously allocated\u002Frandomized to study intervention in any sub study of protocol MK-3475-U03\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* Has an active infection requiring systemic therapy\n* Has history of human immunodeficiency virus (HIV) infection\n* Has hepatitis B or hepatitis C virus infection","120 Years",{"count":471,"type":21},140,[207,178],"Substudy 03C is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03).\n\nThe goal of substudy 03C is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with clear cell renal cell carcinoma (ccRCC) who have recurrent disease during or after anti-programmed cell death 1\u002Fprogrammed cell death ligand 1 (PD-\\[L\\]1) adjuvant therapy.\n\nThis substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study",[27],[476,477],"Vascular Endothelial Growth Factor Receptor-Tyrosine Kinase Inhibitor (VEGFR-TKI)","Hypoxia-Inducible Factor-2α (HIF-2α)","2026-05-21",{"date":455,"type":36},{"date":481,"type":36},"2025-07-20",{"date":483,"type":21},"2031-10-26",{"name":145,"class":95},29,{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":22,"phases":494,"briefSummary":495,"conditions":496,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":506},"100520214","phase-2-phase-2-study-of-combination-tivozanib-and-nivolumab-in-advanced-non-clear-cell-renal-cell-carcinoma-100520214","NCT06053658","Phase 2 Study of Combination Tivozanib and Nivolumab in Advanced Non-Clear Cell Renal Cell Carcinoma","Inclusion Criteria:\n\n1. Patients with histologically or cytologically confirmed metastatic non-clear cell renal cell carcinoma of papillary, chromophobe, oncocytic neoplasms, unclassified, or not otherwise specified (NOS) as clear cell. Medullary carcinoma of the kidney and collecting duct tumors are NOT allowed\n2. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n3. Up to 1 systemic line of therapy (either monotherapy or combination) including prior immunotherapy (anti-PD1, PD-L1, or CTLA-4) and multi-tyrosine kinase inhibitors in non-metastatic or metastatic setting is allowed. A washout period of 5 half lives or 21 days, whichever one is shorter, will be required for patients that have received previous systemic therapy.\n4. Age ≥18 years.\n5. Eastern Cooperative Oncology Group (ECOG) Appendix 1 performance status ≤2 (Karnofsky ≥60%).\n6. Patients must have adequate organ and marrow function as defined below:\n\n   1. absolute neutrophil count ≥1,000\u002FmcL\n   2. platelets ≥100,000\u002FmcL\n   3. total bilirubin ≤ institutional upper limit of normal (ULN)\n   4. AST ≤3 × institutional ULN\n   5. (ALT) ≤3 × institutional ULN\n   6. creatinine ≤1.5 × institutional ULN\n   7. eGFR ≥30 ml\u002Fmin\n7. 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.\n8. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n9. Patients with treated brain metastases (at least 4 weeks have passed from treatment) are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n10. Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.\n11. 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.\n12. 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.\n13. The effects of combination tivozanib and nivolumab on the developing human fetus are unknown. For this reason and because tyrosine kinase inhibitors and immunotherapy agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential (WOCBP) 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) 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. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device, Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide.\n\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. 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.\n14. 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 combination tivozanib and nivolumab administration.\n15. Participants or their legally acceptable representative (LAR) 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.\n\nExclusion Criteria:\n\n1. Prior tivozanib therapy.\n2. Prior nivolumab therapy.\n3. 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.\n4. Patients who are receiving any other investigational agents.\n5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to tivozanib or nivolumab.\n6. Uncontrolled hypertension defined as systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg on 2 or more antihypertensive medications, documented on 2 consecutive measurements taken at least 2 hours apart. Anti-hypertensives must not have been increased 30 days prior to enrollment.\n7. History of autoimmune disorders except for the following:\n\n   1. Patients with vitiligo or alopecia\n   2. Hypothyroidism (e.g. following Hashimoto syndrome) that is stable on thyroid hormone replacement\n   3. Any chronic skin condition that does not require systemic therapy\n   4. Patients without active autoimmune disease requiring treatment in the last 3 years may be included after consultation with study MDA lead Principal Investigator\n8. Active human immunodeficiency virus (HIV) infection unless patients are on effective anti-retroviral therapy with undetectable viral load within 6 months.\n9. Has evidence of any other medical conditions, psychiatric condition, physical examination or laboratory findings that may interfere with the planned treatment, affect subject compliance or place the subject at high risk from treatment-related complications in the opinion of the local principal investigator (PI).\n10. Current systemic corticosteroid use greater than prednisone 10 mg daily or equivalent.\n11. Pregnant women are excluded from this study because tivozanib and nivolumab 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 tivozanib and nivolumab, breastfeeding should be discontinued if the mother is treated with tivozanib and nivolumab.\n12. Receiving concomitant CYP3A inducers.",{"count":493,"type":21},48,[178],"To learn if giving tivozanib in combination with nivolumab can help to control advanced nccRCC.",[27],"2026-05-19",{"date":499,"type":36},"2026-05-20",{"date":501,"type":36},"2024-01-05",{"date":503,"type":21},"2028-11-01",{"name":505,"class":43},"M.D. Anderson Cancer Center",6,{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":513,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":515,"targetDuration":4,"studyType":22,"phases":516,"briefSummary":517,"conditions":518,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":521,"completionDateStruct":522,"leadSponsor":524,"locationsCount":526},"100638689","phase-2-pembrolizumab-plus-belzutifan-with-or-without-lenvatinib-in-localized-renal-cell-carcinoma-100638689","NCT07593040","Pembrolizumab Plus Belzutifan With or Without Lenvatinib in Localized Renal Cell Carcinoma","A Randomized Phase 2 Trial of Neoadjuvant Pembrolizumab Plus Belzutifan With or Without Lenvatinib in Patients With Localized Renal Cell Carcinoma","Moonlanding","Inclusion Criteria:\n\n* Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent.\n\n  2\\. Willing to provide written informed consent. They may also provide consent for Future Biomedical Research; however, the participant may participate in the main trial without participating in the Future Biomedical Research.\n\n  3\\. Histologically confirmed diagnosis of RCC with a clear cell component with or without sarcomatoid features. Diagnosis is to be made by the investigator and does not require central histology review.\n\n  4\\. Tumours must be T2 with grade 4, T3, T4, or any T with N1, M0 on radiographic imaging using TNM staging (8th edition)\n  1. T2 is defined as a tumour \\>7cm but limited to the kidney; grade 4 is per the International Society of Urological Pathology (ISUP) grading.\n  2. T3 is defined as tumour extension into major veins or perinephric tissues, but not into ipsilateral adrenal gland or beyond Gerota's fascia.\n  3. T4 is defined as a tumour involving the ipsilateral adrenal gland or invading beyond Gerota's fascia.\n  4. N1 is defined as metastatic involvement of regional lymph nodes. 5. Archival tumour tissue sample or newly obtained core, incisional, or excisional biopsy of a tumour lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.\n\n     6\\. Have an Eastern Cooperation Oncology Group (ECOG) Performance Status of 0 to 1.\n\n     Evaluation of ECOG is to be performed within 14 days prior to the first dose of study intervention.\n\n     7\\. Have been considered suitable for curative intent surgery (partial or total nephrectomy), as evaluated by a surgeon. 8. Have adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150\u002F90 mm Hg.\n\n     9\\. Have adequate organ function as defined in the following table (Table 7). Specimens must be collected within 14 days prior to the start of study intervention.\n\n     10.Participants agree to the contraception guidelines outlined in section 5.1.3.2.\n\n     11.Participants who are HBsAg positive are eligible if they have received hepatitis B virus (HBV) anti-viral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.\n\n     Note: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.\n\n     Hepatitis B screening tests are not required unless:\n\n     Known history of HBV infection As mandated by local health authority 12.Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.\n\n     Note: Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.\n\n     Hepatitis C screening tests are not required unless:\n\n     Known history of HCV infection As mandated by local health authority 13.HIV-infected participants must have well-controlled HIV on antiretroviral therapy (ART), defined as:\n\n  \u003C!-- -->\n\n  1. Participants on ART must have a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening.\n  2. Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the lower limit of quantification (LLOQ) (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening\n  3. It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.\n  4. Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the stud\n\nExclusion Criteria:\n\n* 1\\. Has evidence of metastatic disease on screening imaging. 2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).\n\n  3\\. Has received prior systemic anti-cancer therapy including investigational agents within 3 years prior to randomization.\n\n  4\\. Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.\n\nParticipants with low-risk early-stage prostate cancer either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.\n\n5\\. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. COVID-19 and influenza vaccinations are allowed provided they are not live vaccines 6. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\n\n7\\. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug 8. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients, and\u002For lenvatinib, and\u002For belzutifan.\n\n9\\. Has active autoimmune disease that has required immunosuppressive systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid).\n\n10.Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease11.Has any of the following:\n\n1. A pulse oximeter reading \\\u003C92% at rest, or\n2. Requires intermittent supplemental oxygen, or\n3. Requires chronic supplemental oxygen. 12.Has an active infection requiring systemic intravenous therapy. 13.Has moderate to severe hepatic impairment (Child-Pugh B or C). 14.Concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.\n\nNote: Hepatitis B and C screening tests are not required unless:\n\n1. Known history of HBV and HCV infection\n2. As mandated by local health authority\n\n15.Has urine protein ≥1 g\u002F24 hours.\n\n1. Note: Participants with proteinuria ≥2+ (≥100 mg\u002FdL) on urine dipstick testing (urinalysis) will undergo 24-hour urine collection for quantitative assessment of proteinuria.\n2. Note: Urine dipstick is the preferred method for testing urinary protein, however, urinalysis may be used if the use of urine dipsticks is not feasible.\n\n   16.Has had major surgery within 3 weeks prior to first dose of study interventions.\n\n   Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility 17.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.\n\n   18.Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n\n   19.Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n\n   20.Has had an allogenic tissue\u002Fsolid organ transplant. 21.Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula22.Has a left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO).\n\n   23.Prolongation of QTcF interval to \\>480 ms. 24.Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. Note: Medically controlled arrhythmia would be permitted.\n\n   25.Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.\n\n   26.Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib 27.Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort)",{"count":105,"type":21},[178],"This study is designed to evaluate the efficacy of belzutifan in combination with pembrolizumab with or without lenvatinib in the neoadjuvant setting, followed by adjuvant pembrolizumab versus adjuvant pembrolizumab alone, as treatment for participants with intermediate-high and high risk clear cell renal cell carcinoma (ccRCC).",[27],"2026-05-18",{"date":499,"type":36},{"date":371,"type":21},{"date":523,"type":21},"2031-06",{"name":525,"class":43},"Vall d'Hebron Institute of Oncology",14,{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":22,"phases":535,"briefSummary":536,"conditions":537,"keywords":539,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":541,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":20},"100590331","phase-1-study-of-dcc-2812-in-participants-with-advanced-genitourinary-cancers-100590331","NCT06966024","Study of DCC-2812 in Participants With Advanced Genitourinary Cancers","An Open-label, Phase 1 Study of DCC-2812 Monotherapy in Participants With Advanced or Metastatic Renal Cell Carcinoma, Urothelial Cancer, or Castration-Resistant Prostate Cancer","Key Inclusion Criteria:\n\n* Have confirmed Advanced or Metastatic Renal Cell Carcinoma, Urothelial Cancer, or Castration-Resistant Prostate Cancer\n* Able to take oral medication\n* If a female is of childbearing potential, must have a negative pregnancy test prior to enrollment and all participants agree to follow the contraception requirements\n* Adequate organ function and electrolytes\n\nKey Exclusion Criteria:\n\n* Received any prior anticancer therapy or any investigational therapy within a specified timeframe prior to first dose of DCC-2812\n* Impaired cardiac function\n* Major surgery within 28 days of the first dose of study drug",{"count":205,"type":21},[207],"This is a multicenter clinical trial to evaluate the safety and preliminary activity of the selective general control nonderepressible 2 (GCN2) activator DCC-2812 as monotherapy in advanced\u002Fmetastatic renal cell carcinoma (RCC), urothelial carcinoma, and castration-resistant prostate cancer.",[27,110,538],"Castration-resistant Prostate Cancer",[540],"Advanced malignancies",{"date":499,"type":36},{"date":543,"type":36},"2025-08-27",{"date":545,"type":21},"2029-02",{"name":547,"class":95},"Deciphera Pharmaceuticals, LLC",{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":4,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":555,"targetDuration":4,"studyType":22,"phases":557,"briefSummary":558,"conditions":559,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":44},"100614857","phase-2-the-cancer-connected-access-and-remote-expertise-beyond-walls-program-to-provide-in-home-cancer-treatment-and-improve-treatment-satisfaction-in-cancer-patients-living-in-the-florida-panhandle-and-surrounding-areas-100614857","NCT07285044","The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas","Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas","Inclusion Criteria:\n\n* Patient has had adequate tolerability of their clinical standard of care treatment, in the opinion of their treating physician, and no clinically significant drug-related reactions occurred prior to consent\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) Food and Drug Administration (FDA)-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. National Comprehensive Cancer Network \\[NCCN\\], American Society of Clinical Oncology \\[ASCO\\], American Society of Hematology \\[ASH\\], etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines\n* A social stability screener, used per standard of care, indicates patient is appropriate to participate in the CCBW program\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3 at the discretion of the treating physician\n* Female or male patients age \\>= 18 years at the time of consent\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Patients with histologically confirmed malignancy who are currently receiving treatment with one of the eligible treatment regimens. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis alone: histologic confirmation is not required.\n\n  * Note: patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving hormonal or immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Co-administration with hormonal agents such as anti-androgens, poly(ADP-ribose) polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, selective estrogen receptor modulators (SERMs), or aromatase inhibitors are allowed, however combinations of oral regimens only are not permitted. Patients may receive any combination of any listed medications or regimens\n  * Eligible disease cancer types:\n\n    * Amyloidosis\n    * Basal cell carcinoma\n    * Biliary\n    * Bladder\n    * Breast\n    * Cervical\n    * Colorectal\n    * Endometrial\n    * Fallopian tube\n    * Gastroesophageal\n    * Glioblastoma\n    * Head and neck\n    * Hepatocellular\n    * Hodgkin lymphoma\n    * Lung\n    * Mantle cell lymphoma\n    * Merkle cell carcinoma\n    * Multiple myeloma\n    * Melanoma\n    * Myelodysplastic syndrome\n    * Ovarian\n    * Pancreatic\n    * Peritoneal\n    * Prostate\n    * Renal cell carcinoma\n    * Squamous cell carcinoma\n    * Urothelial carcinoma\n  * Eligible regimens\n\n    * Atezolizumab +\u002F- bevacizumab\n    * Avelumab\n    * Bevacizumab\n    * Bortezomib\n    * Cemiplimab\n    * Daratumumab +\u002F- bortezomib\n    * Darbepoetin alpha\n    * Degarelix\n    * Denosumab (Xgeva)\n    * Durvalumab\n    * Fluorouracil +\u002F- bevacizumab\n    * Fulvestrant\n    * Goserelin\n    * Ipilimumab +\u002F- Nivolumab\n    * Lanreotide\n    * Leuprolide\n    * Nivolumab\n    * Nivolumab + relatlimab\n    * Octreotide\n    * Pembrolizumab\n    * Pertuzumab +\u002F- trastuzumab\n    * Trastuzumab +\u002F- pertuzumab\n    * Zoledronic acid (Zometa)\n* Willingness to follow birth control requirements for females and males of reproductive potential\n* Resides within the Florida Panhandle and surrounding area serviced by the at-home healthcare supplier utilized for the study and a paramedic network\n* Patient's residence has an existing Wi-Fi connection or can be connected using using a mobile Wi-Fi device provided as part of the program so as to enable a reliable connection with the remote CCBW Command Center at Mayo Clinic\n* Patients who, according to documentation from their treating provider, plan to continue the eligible treatment regimen they are currently prescribed for \\>= 12 weeks from the time of registration\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nExclusion Criteria:\n\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Receiving any investigational agent which would be considered as a treatment for the primary neoplasm.\n\n  * Note: oral concomitant medications for oncologic indications will be maintained per standard of care treatment and not considered part of the trial. Any nononcologic medication, regardless of route of administration will be maintained per standard of care treatment and also not considered part of the trial; therefore, patients receiving oral anti-cancer or other medications per standard of care treatment in addition to any of the medications listed are considered eligible for this trial\n* Individuals who require continuous (24\u002F7) assistance with daily living and are unable to independently manage the technology required for study participation, unless a caregiver is available and willing to provide consistent support throughout the study\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)",{"count":556,"type":21},27,[178],"This phase II trial studies whether providing cancer treatment in the home is preferred over the traditional clinic setting and if it improves treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas. Typically, drug-related cancer care is provided at a medical center which causes patients to have to spend considerable time away from their family, friends, and familiar surroundings. This may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. The Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) program uses a specialized care team trained to provide cancer treatment in the patient's home setting. It is designed to support remote connection between the home health team and providers and Mayo clinic. This may be preferred over the traditional clinic setting which may improve treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas.",[560,561,562,563,564,565,566,567,568,569,570,571,572,274,573,574,277,575,70,211,576,577,578,579,580,581,27,582,110],"Amyloidosis","Basal Cell Carcinoma","Biliary Tract Carcinoma","Bladder Carcinoma","Breast Carcinoma","Cervical Carcinoma","Colorectal Carcinoma","Endometrial Carcinoma","Fallopian Tube Carcinoma","Gastroesophageal Junction Carcinoma","Glioblastoma","Head and Neck Carcinoma","Hematopoietic and Lymphatic System Neoplasm","Hodgkin Lymphoma","Lung Carcinoma","Mantle Cell Lymphoma","Multiple Myeloma","Myelodysplastic Syndrome","Ovarian Carcinoma","Pancreatic Carcinoma","Primary Peritoneal Carcinoma","Prostate Carcinoma","Squamous Cell Carcinoma","2026-05-15",{"date":519,"type":36},{"date":586,"type":36},"2025-12-18",{"date":588,"type":21},"2026-12-18",{"name":297,"class":43},{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":4,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":597,"enrollmentInfo":598,"targetDuration":4,"studyType":22,"phases":600,"briefSummary":601,"conditions":602,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":611},"100605270","phase-1-a-phase-i-clinical-study-to-evaluate-the-pk-profile-efficacy-safety-and-immunogenicity-of-hlx17-vs-keytruda-in-multiple-resected-solid-tumors-100605270","NCT07160335","A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors","A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® (US-sourced Keytruda®) in Multiple Resected Solid Tumors","Inclusion Criteria:\n\n1. Participants must have signed and dated an Institutional Review Board\u002FIndependent Ethics Committee (IRB\u002FIEC) approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines.\n2. At least 18 years and no older than 85 years (including 85 years old) at the time of signing the ICF.\n3. 18 kg\u002Fm2 ≤ body mass index (BMI) ≤ 30 kg\u002Fm2 and 50 kg ≤ body weight ≤ 85 kg.\n4. The patient with one of the following resected solid tumors:\n\n   * NSCLC patients after complete resection OR\n   * Melanoma following complete resection OR\n   * Renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.\n5. Have a performance status of 0 on the Eastern Cooperative Oncology Group (ECOG) Performance Status within 7 days prior to the first dose in this study.\n6. Have a life expectancy of at least 12 weeks.\n7. Have adequate organ function as indicated by the following laboratory values (no blood transfusions, or treatment with albumin, recombinant human thrombopoietin or colony-stimulating factor within 14 days prior to the first dose in this study)\n8. Female patients must meet one of the following conditions:\n\n   1. Menopause (defined as no menstruation for at least 1 year with no confirmed cause other than menopause), or\n   2. Surgically sterilized (removal of the ovaries and\u002For uterus), or\n   3. Fertile, but must:\n\n      * be tested negative for serum\u002Furine pregnancy test within 7 days prior to the randomization, and\n      * agree to use contraception methods with an annual failure rate of \\\u003C 1% or to remain abstinent (avoid heterosexual intercourse from signing the ICF to at least 6 months after the last dose of the study drug) (a contraceptive method with an annual failure rate of \\\u003C 1% includes bilateral tubal ligation, male sterilization, correct use of hormonal contraceptives that can inhibit ovulation, hormone-releasing intrauterine devices and copper-containing intrauterine devices or condoms), and\n      * not breastfeed\n9. Male patients must: agree to remain abstinent (avoid heterosexual intercourse) or take contraception measures as follows: male patients with a pregnant partner or a partner of childbearing potential must remain abstinent or use condoms to prevent drug exposure to the embryo during study treatment and for at least 6 months after the last dose of study drug. Periodic abstinence (e.g., contraception based on calendar day, ovulatory phase, basal body temperature, or postovulatory phase) and external ejaculation are ineligible methods of contraception.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. History of illicit drug use or alcohol abuse within 12 months prior to randomization in the investigator's judgment.\n3. Participants with NSCLC have two synchronous primary non-small cell lung cancers or other histopathological types (such as mixed adenosquamous carcinoma, small cell lung cancer, or neuroendocrine carcinoma)； known positive for EGFR sensitive mutations or ALK fusion. EGFR sensitive mutations include: exon 19 deletion mutation (19DEL) and exon 21 point mutation (21L858R).\n4. Participants with MEL have mucosal or ocular melanoma.\n5. Participants with RCC have pre-existing brain or bone metastatic lesions, or residual thrombus in the renal vein or vena cava after nephrectomy.\n6. Participants with other primary active malignancies within 5 years or at the same time prior to randomization.\n7. Have received an organ or bone marrow transplantation prior to randomization or scheduled for transplantation during the study.\n8. Presence of central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n9. Symptomatic cerebrovascular disease or known myocardial infarction or poorly controlled arrhythmia (including QTcF intervals ≥ 450 ms for males and ≥ 470 ms for females calculated by Fridericia's formula) within 6 months prior to randomization.\n10. Chronic heart failure (Class III to IV based on NYHA classification) or an LVEF (left ventricular ejection fraction) assessed with the doppler echocardiography less than 50%.\n11. Peripheral neuropathy greater than or equal to Grade 2 (CTCAE).\n12. Known human immunodeficiency virus (HIV) infection (or positive anti-HIV during screening), or known Hepatitis B (or positive test for HBsAg or HBcAb and positive test for HBV-DNA during screening), or known Hepatitis C (or positive tests for HCV antibody and HCV-RNA during screening), or known Hepatitis B and C co-infection (or positive test for HBsAg or HBcAb and positive test for HCV antibody during screening), or active pulmonary tuberculosis within 6 months prior to randomization.\n13. Known interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and severe lung function abnormalities that may impede the investigators' diagnosis and management of drug-related pulmonary toxicity prior to screening.\n14. Known severe allergic or anaphylactic reactions to pembrolizumab or any other monoclonal antibody or any components of the investigational medicinal products.\n15. Known active or suspected autoimmune diseases. Patients with stable disease who do not require systemic immunosuppressive therapy may also participate.\n16. Unstable hyperthyroidism or hypothyroidism at screening.\n17. Have received live vaccines within 28 days prior to the first dose in this study (Inactivated viral vaccines for seasonal influenza are allowed).\n18. Treatment with systemic corticosteroids (\\> 10 mg\u002Fday prednisone efficacy dosage) or other immunosuppressive drugs within 14 days prior to the first dose or during the study. However, participants are allowed to be enrolled under the following conditions: in the absence of active autoimmune disease, participants are allowed to use topical or inhaled steroids and adrenal hormone replacement therapy at dosages equivalent to ≤ 10 mg\u002Fday of prednisone efficacy.\n19. Any active infection requiring systemic therapy within 1 month prior to the first dose in this study.\n20. Participants have planning to undergo surgical treatment during this clinical trial. Tumor puncture or incisional lymph node biopsy is allowed.\n21. Have received pembrolizumab or any other immune checkpoints inhibitors (PD-1, PD-L1, CTLA4, etc.) before randomization.\n22. Participants have participated in a clinical study with another investigational medicinal product prior to randomization, and the interval between the current study and the previous study is too short: within 1 month prior to the first dose of the current study or within 5 half-lives of the previous investigational medicinal product (whichever is longer). Or planning to participate in a clinical study with another investigational medicinal product before completing all scheduled assessments in this clinical study.\n23. Participants have participated in a device clinical study within 1 month prior to screening, or are participating in another surgical or device clinical study at the time of screening, or plan to participate in another surgical or device clinical study during this clinical study.\n24. The investigator has a clear reason to believe that participation in this study would be detrimental to the participant.","85 Years",{"count":599,"type":21},174,[207],"This is a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to evaluate the similarity in PK profile, efficacy, safety, and immunogenicity of HLX17 vs. US-sourced Keytruda® in patients with resected non-small cell lung cancer (NSCLC) or melanoma (MEL), or renal cell carcinoma (RCC).",[209,70,27],"2026-05-14",{"date":583,"type":36},{"date":606,"type":36},"2025-09-26",{"date":608,"type":21},"2028-03-27",{"name":610,"class":95},"Shanghai Henlius Biotech",69,{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":4,"eligibilityCriteria":618,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":619,"targetDuration":4,"studyType":22,"phases":620,"briefSummary":621,"conditions":622,"keywords":624,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":626,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":44},"100493077","phase-1-drug-screening-using-novel-imd-in-renal-cell-carcinoma-100493077","NCT05700461","Drug Screening Using Novel IMD in Renal Cell Carcinoma","Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Response in Renal Cell Carcinoma","Inclusion Criteria:\n\n* Patients must have the ability to understand and the willingness to sign a written informed consent document.\n* Participants must have confirmed or suspected localized or metastatic renal cell carcinoma, and must be planned for either nephrectomy or metastatectomy as part of their clinical care. The lesion planned for excision must be at least 1cm in size.\n* Participants must be 18 years of age or older.\n* Participants must be evaluated by a medical oncologist who will determine the clinically appropriate treatment strategy based on clinical history and extent of disease.\n* Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures.\n* Participants will undergo laboratory testing within 30 days prior to the procedure (or within 72 hours if there has been a change in the clinical status since the initial blood draw). Patients must have absolute neutrophil count ≥1,000\u002FmcL, platelets ≥50,000\u002FmcL, INR \\\u003C 1.5 and PTT \\\u003C1.5x control.\n* Participants must have undergone CT or MRI that assesses the extent of disease and allows the research team to assess for study eligibility. This will have been done as part of the standard-of-care.\n* The participant's case must be reviewed by representatives of interventional radiology and the appropriate surgical subspecialty to assess the following factors:\n* Patient is clinically stable to undergo microdevice implantation and surgical procedures\n* Patient has sufficient volume of disease to allow implantation of the microdevice\n* Patient has a lesion for which the microdevice is a) amenable to percutaneous placement, and b) amenable to removal at the time of surgery\n* Patients must be willing to undergo research-related genetic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories.\n\nExclusion Criteria\n\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit the safety of a biopsy and\u002For surgery.\n* Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures (detailed below).",{"count":329,"type":21},[207],"This research is being done to study the safety and feasibility of implanting and retrieving a microdevice that releases microdoses of 19 specific drugs or drug combinations as a possible tool to evaluate the effectiveness of several cancer drugs against metastatic renal cell carcinoma (RCC).\n\nThe name of the intervention(s) involved in this study are:\n\n* Implantable Microdevice (IMD)\n* Surgery (excision of tumor)\n* Drugs used in this study will only include drugs already used as standard of care for the treatment of metastatic renal cell carcinoma (RCC)",[27,623,395],"Metastatic Renal Cell Carcinoma",[27,623,395,625],"Suspected Renal Cell Carcinoma",{"date":519,"type":36},{"date":628,"type":36},"2024-12-01",{"date":630,"type":21},"2029-08-31",{"name":632,"class":43},"Oliver Jonas",{"id":634,"slug":635,"hasResults":12,"nctId":636,"briefTitle":637,"officialTitle":638,"acronym":639,"eligibilityCriteria":640,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":641,"targetDuration":4,"studyType":22,"phases":642,"briefSummary":643,"conditions":644,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":652,"locationsCount":44},"100441049","assessment-of-quality-of-life-and-outcomes-in-patients-with-primary-renal-cell-carcinoma-treated-with-sbrt-100441049","NCT05023265","Assessment of Quality of Life and Outcomes in Patients With Primary Renal Cell Carcinoma Treated With SBRT","Assessment of Quality of Life and Outcomes in Patients Treated With Stereotactic Body Radiotherapy (SBRT) for Inoperable Renal Cell Carcinoma (RCC): A Multicenter Phase II Study","AQuOS-II","Inclusion Criteria:\n\n* Patients ≥18 years old\n* Newly diagnosed RCC by biopsy (preferred) or radiologic evidence of growth on surveillance over two consecutive assessments (6-12 months)\n* Primary lesion \\>3 cm, or recurrent lesion following local ablative therapy\n* Medically inoperable or patient who refuses surgery following assessment by experienced urologist, and discussed in a multidisciplinary setting\n* ECOG 0-2\n* Written informed consent\n* Participants must be able to understand the English-language or with the aid of a translator\n\nExclusion Criteria:\n\n* Primary Lesion \\>20cm\n* Evidence of distant metastatic disease\n* Previous abdominal RT in vicinity of kidney preventing definitive SBRT\n* History of major radiosensitivity syndrome\n* Second invasive malignancy within the past 3 years (excluding non-melanomatous skin cancer)\n* Currently pregnant or lactating",{"count":413,"type":21},[24],"This is a multicenter, single arm phase II study of stereotactic body radiation therapy (SBRT) for patients with medically inoperable primary renal cell carcinoma (RCC).",[27],"2026-04-27",{"date":647,"type":36},"2026-04-28",{"date":649,"type":36},"2022-02-08",{"date":651,"type":21},"2026-10-01",{"name":653,"class":43},"Sunnybrook Health Sciences Centre",{"id":655,"slug":656,"hasResults":12,"nctId":657,"briefTitle":658,"officialTitle":659,"acronym":660,"eligibilityCriteria":661,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":662,"targetDuration":4,"studyType":22,"phases":664,"briefSummary":665,"conditions":666,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":673,"lastUpdatePostDateStruct":674,"startDateStruct":676,"completionDateStruct":678,"leadSponsor":680,"locationsCount":44},"100610118","phase-2-patient-preference-for-subcutaneous-vs-intravenous-immune-therapy-100610118","NCT07223424","Patient Preference for Subcutaneous vs. Intravenous Immune Therapy","Patient Preference for Subcutaneous vs. Intravenous Immune Therapy (PSI-Immune)","PSI-Immune","Inclusion Criteria:\n\n* Able to understand and willing to sign a written informed consent document.\n* Able to read and write in English.\n* Must be eligible to receive nivolumab (Cohorts A-1, B-1) or pembrolizumab (Cohorts A-2, B-2) singly or in combination with other FDA-approved agents (TKIs or chemotherapy) according to standard of care practices, as determined by the clinical judgment of the investigator.\n* Prior and concurrent therapy criteria\n\n  o Patients should either be ICI-naïve (Cohorts A-1, A-2) or be currently receiving adjuvant or front-line PD-(L)1 based therapy singly or in combination with FDA-approved agents (TKIs or chemotherapy) (Cohorts B-1, B-2).\n* Locally advanced or advanced\u002Fmetastatic solid tumor for which nivolumab OR pembrolizumab is on-label.\n\n  * NOTE: IV nivolumab is FDA-approved in the following indications: RCC, melanoma, NSCLC, SCCHN, UC, dMMR\u002FMSI-H CRC, HCC, esophageal cancer, and gastric, gastroesophageal and esophageal adenocarcinoma (gastric\u002FGEJ).\n  * NOTE: IV pembrolizumab is FDA-approved in the following indications: RCC, melanoma, NSCLC, SCCHN, UC, dMMR\u002FMSI-H CRC, HCC, esophageal cancer, gastric\u002FGEJ, cervical cancer, cutaneous squamous cell carcinoma (cSCC), Merkel cell carcinoma (MCC), endometrial carcinoma, tumor mutational burden-high (TMB-H) cancers, triple negative breast cancer (TNBC).\n* Cohort-specific criteria.\n\n  * Cohort A-1: Patients who are treatment-naive (i.e. for whom nivolumab is planned but has not yet been initiated) are eligible to enroll.\n  * Cohort B-1: Patients who are already receiving treatment with nivolumab (singly or in combination with TKI or chemotherapy) OR a different ICI-therapy but are willing to switch to nivolumab monotherapy or nivolumab based combinations may eligible to enroll if nivolumab is on-label for their cancer.\n  * Cohort A-2: Patients who are treatment-naive (i.e. for whom pembrolizumab is planned but has not yet been initiated) are eligible to enroll.\n  * Cohort B-2: Patients who are already receiving treatment with pembrolizumab (singly or in combination with TKI or chemotherapy) OR a different ICI-therapy but are willing to switch to pembrolizumab monotherapy or pembrolizumab based combinations may eligible to enroll if pembrolizumab is on-label for their cancer.\n  * NOTE: Patients who are currently receiving nivolumab + ipilimumab combination as induction may be eligible to enroll in Cohort B-1 following induction (i.e. during planned maintenance) in indications including but not limited to advanced\u002Fmetastatic melanoma, ccRCC, MSI-H\u002FdMMR mCRC.\n  * NOTE: Patients for whom nivolumab + ipilimumab combination is planned as maintenance are not eligible (i.e. NSCLC patients being treated per CheckMate-227 or CheckMate-9LA).\n  * NOTE: Patients for whom anti-PD-1 based immunotherapy is planned as neoadjuvant therapy are not appropriate. Such patients may be considered for enrollment at the time of commencing adjuvant therapy in cohorts A-2 or B-2 as appropriate.\n\nExclusion Criteria:\n\n* Participant unable to receive nivolumab (or pembrolizumab) due to prior allergic reactions to nivolumab (or pembrolizumab) or any of its ingredients.\n* Has severe hypersensitivity (≥Grade 3) to nivolumab (or pembrolizumab) and\u002For any of its excipients.\n* Has had an allogenic tissue\u002Fsolid organ transplant.",{"count":663,"type":21},880,[178],"The study will evaluate patient and Health Care Professional- reported preference for Subcutaneous (SC) compared with IV nivolumab administration or similarly for SC compared with IV pembrolizumab.",[27,667,70,668,274,669,65,582,670,63,671,672],"Non Small Cell Lung Cancer","Colo-rectal Cancer (dMMR\u002FMSI-H CRC)","Ulcerative Colitis","Gastric\u002FGEJ","Gastro-Esophageal Adenocarcinoma","Esophageal Adenocarcinoma","2026-04-13",{"date":675,"type":36},"2026-04-16",{"date":677,"type":36},"2025-11-04",{"date":679,"type":21},"2030-11-30",{"name":681,"class":43},"Diwakar Davar",{"id":683,"slug":684,"hasResults":12,"nctId":685,"briefTitle":686,"officialTitle":687,"acronym":4,"eligibilityCriteria":688,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":689,"targetDuration":4,"studyType":22,"phases":690,"briefSummary":691,"conditions":692,"keywords":697,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":702,"lastUpdatePostDateStruct":703,"startDateStruct":704,"completionDateStruct":706,"leadSponsor":708,"locationsCount":404},"100560812","phase-1-safety-pk-and-efficacy-of-qxl138am-in-patients-with-solid-tumors-and-multiple-myeloma-100560812","NCT06582017","Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma","A First-in-human Phase 1a\u002F1b Study to Evaluate Safety and Tolerability of QXL138AM in Patients With Locally Advanced Un-resectable and\u002For Metastatic Solid Tumors and Multiple Myeloma","Inclusion Criteria:\n\n1. Participants with Solid Tumors\n\n   * Histopathologically confirmed diagnosis of an advanced, unresectable, or metastatic solid tumor (ovarian, pancreatic, urothelial, renal, hepatocellular, gastrointestinal (GI), lung, prostate, and breast cancer).\n   * Have progressed despite standard therapies, or for whom conventional therapy is not effective or tolerable, as judged by the Investigator. Patients must have no available therapeutic options known to confer clinical benefit for their tumor type.\n2. Participants with Multiple Myeloma\n\n   * Have progressed despite standard therapies, or for whom conventional therapy is not effective or tolerable, as judged by the Investigator.\n   * Patients must have failed at least 3 prior therapies for myeloma and should have had prior exposure to a proteosome inhibitor, an IMiD, and an anti-CD38-directed therapy.\n\n2\\. Male or female participants ≥18 years of age at the time of informed consent 3. An Eastern Cooperative Oncology Group (ECOG) performance status scale of 0, 1, or 2 at Screening 4. Must have at least 1 measurable lesion by RECIST version 1.1 (solid tumors only), or evaluable disease by IMWG Uniform Response Criteria (multiple myeloma only) 5. Adequate organ function and bone marrow reserve 6. Adequate cardiac function as estimated by left ventricular ejection fraction 7. Female participants of child-bearing potential must:\n\n* Have a negative serum pregnancy test at screening and a negative pregnancy test at Week 1 Day 1 prior to first dose of QXL138AM, AND\n* Agree to use at least 1 highly effective method of contraception for the duration of study participation, and for 120 days after last dose of QXL138AM.\n\n  8\\. Male participants of child-bearing potential must:\n* Agree to use at least 1 highly effective method of contraception for the duration of study participation, and for 120 days after last dose of QXL138AM, AND\n* Refrain from sperm donation prior to the first dose of investigational product through 120 days following the last dose of QXL138AM.\n\nExclusion Criteria:\n\n1. New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, a history of risk factors for Torsades de Pointes (TdP), including heart failure, hypokalemia, and family history of long QTc syndrome, or evidence of ischemia on ECG.\n\n   Symptomatic ischemic heart disease or unstable angina pectoris; or history of cardiac angioplasty, cardiac stenting, or coronary artery bypass graft. A clinically significant baseline prolongation of QT\u002FQTcF interval at screening.\n2. The use of concomitant medications that may significantly prolong the QT\u002FQTc interval.\n3. Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.\n4. Known hypersensitivity to the investigational product or components (anti-CD138 IgG1 antibody, Interferon A2a and\u002For the formulation excipients: histidine, sucrose, arginine, polysorbate 80).\n5. Female participant is lactating.\n6. Any other clinically significant comorbidities.\n7. Received prior anticancer therapy within 28 days or 5x the half-life (whichever is shorter) prior to the first dose of investigational product.\n8. Participants who received wide-field radiation therapy within 4 weeks prior to first dose of investigational product, (2 weeks for limited field radiation therapy)\n9. Major surgery within 30 days before first dose of investigational product\n10. Chronic use of systemic corticosteroids of more than 20 mg\u002Fday of prednisone or equivalent.\n11. Active, clinically significant liver disease such as Hepatitis B or C, autoimmune hepatitis, or cirrhosis (Child Hugh Stage B or C).\n12. Current or history of mood disorder such as major depression per DSM-5 within past two years not controlled with current therapy.\n13. Active autoimmune disorders not controlled with current therapy.\n14. Active endocrine disorders including hypothyroidism, hyperthyroidism, hypoglycemia, hyperglycemia, and diabetes mellitus not controlled with current therapy.",{"count":56,"type":21},[207],"Study QXL138AM-001 is a Phase 1a\u002F1b study to investigate the safety, pharmacokinetics, and preliminary activity of QXL138AM in subjects with locally advanced un-resectable and\u002For metastatic solid tumors and multiple myeloma. The study is an open-label, multicenter, first in human study to be conducted in two major parts which are further organized into two sub-parts. Part A Dose Escalation is a modified 3+3 with the first two cohorts consisting of one subject each based on the low clinical starting dose. Dose escalation in solid tumors (Part A1) will be followed by dose finding in multiple myeloma (Part A2). Part B consists of dose expansion in solid tumors (Part B1) and multiple myeloma (Part B2) using the recommended dose for expansion from Part A",[74,693,110,27,274,694,695,76,696],"Pancreas Cancer","Gastrointestinal Cancer","Lung Cancer","Breast Cancer",[698,699,700,701],"QXL138AM-001","CD138","Interferon A","Nammi Therapeutics Inc.","2026-04-09",{"date":673,"type":36},{"date":705,"type":36},"2024-08-28",{"date":707,"type":21},"2028-05-30",{"name":709,"class":95},"Nammi Therapeutics Inc",{"id":711,"slug":712,"hasResults":12,"nctId":713,"briefTitle":714,"officialTitle":715,"acronym":4,"eligibilityCriteria":716,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":717,"targetDuration":4,"studyType":22,"phases":719,"briefSummary":720,"conditions":721,"keywords":732,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":736,"lastUpdatePostDateStruct":737,"startDateStruct":738,"completionDateStruct":740,"leadSponsor":742,"locationsCount":20},"100543937","phase-1-a-study-of-oral-7hp349-alintegimod-in-combination-with-ipilimumab-followed-by-nivolumab-monotherapy-100543937","NCT06362369","A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy","A Phase 1b\u002F2a Multi-Center, Dose Escalation and Reference Regimen-Controlled, Multi-Cohort Study to Determine the Safety and Efficacy of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy in Patients With Locally Advanced or Metastatic Cancers Following One or More Prior Therapies","Inclusion and Exclusion Criteria for Phase 1b\n\nInclusion Criteria\n\n1. Adult patients (age 18 or older)\n2. Patient has a histologically confirmed diagnosis of any of the following locally advanced or metastatic solid tumors: melanoma, pleural mesothelioma, renal cell carcinoma, MSI-high or mismatch repair-deficient colorectal cancer, hepatocellular carcinoma, and non-small cell lung cancer with no EGFR or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, or tumor types for which the combination of ipilimumab and nivolumab has been FDA approved. Patients may have received treatment with anti PD-1\u002FPD-L1.\n3. ANC ≥ 1000\u002FµL without use of G-CSF, Hgb ≥ 9 g\u002FdL without required blood transfusion for at least 5 days prior to pretreatment baseline, and platelet count ≥ 75,000\u002FµL without transfusions for at least 5 days prior to pretreatment baseline.\n4. ECOG performance status of 0 or 1.\n5. Has a life expectancy of \\> 12 weeks.\n6. Renal and hepatic function requirements:\n\n   * a. Renal function with either an eCrCL ≥ 60 mL\u002Fmin (modified Cockcroft-Gault) or eGFR ≥ 60 mL\u002Fmin\u002F1.73 m2 (using MDRD or CKD-EPI or similar equations).\n   * b. Hepatic function with ALT\u002FAST ≤ 3 x ULN, total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert Syndrome). If patients have hepatic metastases, then AST\u002FALT≤ 5 x ULN will be allowed.\n7. Men receiving the investigational drug and are sexually active with women of child-bearing potential (WCBP) must use contraception during treatment and for 5 half-lives after the last dose of the investigational drug or Women, not otherwise meeting other exclusion criteria, who are WCBP must be on contraception for a minimum duration of 3 months prior to treatment and continue contraception during treatment and for 5 half-lives after the last dose of the investigational drug.\n8. All Grade 3 AEs related to prior therapies have returned to Grade 1 or resolved to baseline (this includes with appropriate therapy in the case of thyroid dysfunction).\n9. All patients must have measurable disease by applicable RECIST criteria.\n10. Willing to allow blood samples to be used for research.\n\nExclusion Criteria:\n\n1. Patients must not have received prior anticancer therapy or radiation therapy within the 3 weeks and must not have undergone major surgery within 4 weeks prior to initiation of treatment on protocol. Palliative radiation therapy is allowed. For small molecules (MW \\\u003C 0.9 kDA), the washout period is 3 weeks or 5 half-lives, whatever comes first.\n2. Active brain metastasis or leptomeningeal disease. Patients with treated brain metastasis must have stable disease, evidenced by MRI brain imaging for at least 4 weeks, and the patient must have been off steroids for at least 2 weeks prior to first dose of study drug.\n3. Previous episodes of ≥ Grade 3 (G3) immune-related toxicity that includes G3 colitis, G3 pneumonitis, G3 skin rash, G3 increase in liver enzymes (with the exception of symptoms that in the opinion of the investigator will not compromise the patients' safety on the trial. Patients with stable endocrinological AEs (e.g., hypothyroidism, adrenal insufficiency, hypopituitarism, or diabetes mellitus) are allowed.\n4. Persistent toxicity of NCI CTCAE version 5 Grade \\> 1 severity that is related to prior therapy.\n\n   Note: Sensory neuropathy, hypothyroidism or alopecia of Grade ≤ 2 are acceptable. Other Grade 2 toxicities of prior treatments that are controlled with medication (e.g., diabetes or hypertension) are permitted.\n5. Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome p450 3A (CYP3A) within 2 weeks before study intervention. Alintegimod may increase exposure to CYP3A4 substrates; consider a dose reduction of such substrates and monitor for signs of toxicities of co-administered sensitive CYP3A substrates (see listing of strong inhibitors and inducer drugs in FDA tables). An alternative is to replace such agents with drugs that are not CYP3A4 metabolized if at all feasible.\n6. The patient has cardiac conditions as follows:\n\n   * a) myocarditis;\n   * b) uncontrolled hypertension (blood pressure \\> 160\u002F100) despite optimal therapy;\n   * c) uncontrolled angina; ventricular arrhythmias; congestive heart failure (New York Heart Association Class II or above);\n   * d) prior or current cardiomyopathy;\n   * e) uncontrolled atrial fibrillation with heart rate \\> 100 beats per minute (bpm); unstable ischemic heart disease (myocardial infarction within 6 months prior to starting treatment or angina requiring use of nitrates more than once weekly);\n   * f) concomitant medication with drugs known to cause Torsades de Pointes;87\n   * g) QT interval correction for heart rate using Fridericia's formula (QTcF) ≥ 470 ms (average from 3 QTcF values on the triplicate 12-lead electrocardiogram \\[ECG\\]) at screening.\n7. Known history of a positive test for HIV, or positive test for hepatitis B (positive for HBsAg) or hepatitis C (HCV RNA).\n8. Concurrent malignancies are permitted if they were previously treated, and all treatment of that malignancy was completed at least 2 years before enrollment and no evidence of disease exists, or with agreement from the Principal Investigator (PI), patients who have a concurrent malignancy that is clinically stable and does not require tumor-directed treatment are eligible to participate if the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low, or with agreement from the PI, other malignancies may be permitted if the risk of the prior malignancy interfering with either safety or efficacy end points is very low. Adequately treated basal or squamous cell carcinoma or carcinoma in situ is allowed.\n9. Men receiving the investigational drug and are sexually active with women of child-bearing potential (WOCBP) must use contraception during treatment and for 5 half-lives after the last dose of the investigational drug or Women, not otherwise meeting other exclusion criteria, who are WOCBP must be on contraception for a minimum duration of 3 months prior to treatment and continue contraception during treatment and for 5 half-lives after the last dose of the investigational drug.\n10. The patient has concurrent severe and\u002For uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes, severe infection requiring active treatment, severe malnutrition, chronic severe liver or renal disease).\n11. Use of corticosteroids or other immunosuppressive medication, current or within 14 days of administration of Alintegimod with the following exceptions:\n\n    * a) Topical, intranasal, inhaled, ocular, intra-articular corticosteroids;\n    * b) Physiological doses of replacement corticosteroids (e.g., for adrenal insufficiency) are not to exceed 10 mg\u002Fday of prednisone or equivalent.\n    * c) Corticosteroid premedication for infusion and\u002For hypersensitivity reactions.\n    * d) Patients may be treated with a short (\\\u003C24h) pulse course of corticosteroids to mitigate infusion or hypersensitivity reactions to radiocontrast agents.\n12. Receipt of live attenuated vaccine within 28 days of the first dose of Alintegimod.\n13. Serious autoimmune disease at the discretion of the treating Investigator: patients with a history of active serious inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g., Wegener's Granulomatosis) are excluded from participation in this study\n14. Active or history of pneumonitis (drug-induced), idiopathic pulmonary fibrosis, Interstitial Lung Disease (ILD), or lung disease that may interfere with assessment of pneumonitis. History of radiation pneumonitis in a previous radiation field is permitted.\n15. Previous participation in a study of any investigational agent within 21 days of enrollment or within 5 half-lives of the study treatment, whichever is the least.\n16. Use of mechanical ventilation or having a resting O2 saturation \\\u003C 90% (on room air) by pulse-oximetry, require renal dialysis, require vasopressors, and\u002For severe hepatic sinusoidal obstruction syndrome.\n17. Proven or suspected ongoing systemic infection requiring IV antibiotics.\n18. Women who are pregnant or lactating.\n\n    Note: Women of childbearing potential (WOCBP) must have a \"negative\" serum pregnancy test within 1 week prior to treatment. Non-childbearing potential is defined as 1 of the following:\n    * a) Postmenopausal with \\> 1 year since last menses and:\n    * 1\\. If ≥ 65 years old, follicle-stimulating hormone (FSH) \\> 40 mIU\u002FmL.\n    * 2\\. If ≥ 65 years old and not on hormone replacement therapy (HRT), FSH \\> 30 mIU\u002FmL.\n    * 3\\. If ≥ 65 years old and on HRT, the FSH requirement is not applicable. Postmenopausal females on HRT will be allowed if HRT has been stable for ≥ 6 months prior to dosing of study drug(s).\n    * b) Written medical documentation of being sterilized (e.g., hysterectomy, double oophorectomy, bilateral salpingectomy) with the procedure performed ≥ 6 months prior to dosing study drug(s).\n\n    Note: Tubal ligation is not considered a form of permanent sterilization.\n19. Psychiatric illness\u002Fsocial circumstances that would limit compliance with study requirements and substantially increase the risk of adverse events or have compromised ability to provide written informed consent.\n20. Patients who have had allogeneic tissue or solid organ transplantation. Prior T cell therapy is allowed\n21. Use of biotin (i.e., Vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 µg (NIH-ODS 2022; Section 5.9.2.1).\n\n    Note: Patients who switch from a high dose to a dose of ≤30 µg\u002Fday are eligible for study entry.\n22. Any condition that is in the opinion of the investigator may compromise patient's participation in the trial.\n23. Active peptic ulcer disease or gastritis, active diverticulitis, or other serious gastrointestinal disease associated with diarrhea within the past 2 years before the start of therapy or GI disease which affects oral drug absorption.\n24. Patients with known soy allergy.",{"count":718,"type":21},126,[207,178],"This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens.\n\nCurrently study will only be enrolling the Phase 1b and the Phase 2a protocol requirements will be added to the study near completion of the Phase 1b",[722,417,70,723,724,27,725,726,355,274,727,728,395,729,667,361,730,731],"Advanced Cancer","Metastasis","Pleural Mesothelioma","MSI-High","Mismatch Repair Deficiency","Hepatocellular Cancer","Renal Cell Cancer","Skin Cancer","Anaplastic Lymphoma Kinase Genomic Tumor Aberrations","ALK Genomic Tumor Aberrations",[733,734,735],"Phase 1","Phase 1b","7 Hills Pharma","2026-04-07",{"date":673,"type":36},{"date":739,"type":36},"2024-08-23",{"date":741,"type":21},"2028-12-31",{"name":743,"class":95},"7 Hills Pharma, LLC"]