[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-clear-cell-renal-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-clear-cell-renal-cell-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,52,79,106,125,151,178,202,221,282,303,344,367,388,410,431,458,484],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100644499","early-phase-1-imaging-study-of-a-caix-binder-in-metastatic-clear-cell-rcc-100644499",false,"NCT07671417","Imaging Study of a CAIX Binder in Metastatic Clear Cell RCC.","A Phase 0 Imaging Study to Assess the Feasibility, Biodistribution, and Dosimetry of a Carbonic Anhydrase IX (CAIX) Binder in Subjects With Metastatic Clear Cell Renal Cell Cancer (RCC).","Inclusion Criteria:\n\n* At least 18 years old at the time of signing the informed consent form (ICF).\n* Biopsy proven metastatic clear cell renal cell carcinoma (RCC)\n\nExclusion Criteria:\n\n* Subjects taking below mentioned medications that cannot be stopped 5 half-lives prior to RYZ512 administration and cannot be restarted until all study-related imaging is completed: Anticonvulsants, Antipsychotics, Carbonic Anhydrase inhibitors, COX-2 Inhibitors, Sulfatase Inhibitors, Sulfonamides\n* Women of Childbearing Potential that are pregnant or breastfeeding.\n\nNote: Additional criteria may apply and will be assessed by the study site","ALL","18 Years",{"count":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","This imaging study aims to assess the feasibility, biodistribution, and dosimetry of a novel Carbonic Anhydrase IX (CAIX) Binder in Subjects with Metastatic Clear Cell Renal Cell Cancer (RCC).",[26],"Metastatic Clear Cell Renal Cell Carcinoma",[28,29,30,31,32,33,34,35,36,37,38],"RCC","Metastatic RCC","Metastatic Clear Cell Renal Cancer","CAIX","CA9","RayzeBio","Rayze","BMS","Bristol Myers Squibb","RPT","Imaging Agent","NOT_YET_RECRUITING","2026-06-22",{"date":42,"type":43},"2026-06-26","ACTUAL",{"date":45,"type":20},"2026-06",{"date":47,"type":20},"2027-01",{"name":49,"class":50},"RayzeBio, Inc.","INDUSTRY",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":74,"leadSponsor":76,"locationsCount":51},"100641105","phase-2-cd70-targeted-immuno-petct-directed-free-of-therapy-used-for-mccrcc-patients-with-imdc-favorable-or-intermediate-risk-100641105","NCT07615348","CD70-Targeted Immuno-PET\u002FCT-Directed Free of Therapy Used for mccRCC Patients With IMDC Favorable or Intermediate Risk","A Phase II Trial of CD70-Targeted Immuno-PET\u002FCT-Directed Treatment Holiday for Metastatic Clear Cell Renal Cell Carcinoma With IMDC Favorable or Intermediate Risk","PERFUMER-70","Inclusion Criteria:\n\nSTEP0: At Treatment Initiation\n\n1. Male or female subjects aged ≥ 18 years\n2. Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC (American Joint Committee on Cancer \\[AJCC\\] Stage IV)\n3. Histologically or cytologically confirmed advanced RCC with predominantly clear-cell subtype\n4. Favorable or intermediate risk as per International Metastatic RCC Database Consortium (IMDC) criteria\n5. Karnofsky Performance Status (KPS) grade ≥ 70%\n6. At least one measurable lesion on CT per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1\n7. At least one high-uptake target lesion on CD70-targeted immuno-PET\u002FCT per Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) version 1.0\n8. If CD70-negative lesions (visible on CT but lacking CD70 avidity on PET\u002FCT) are present at baseline, they must meet ALL the following conditions: cannot be target lesions, cannot be located in major involved organs, must be ≤ 3 in number, and must account for ≤ 30% of the total tumor burden\n9. Adequate organ and bone marrow function meeting all laboratory criteria:\n\n   * Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL; Platelet count ≥ 100 × 10\\^9\u002FL; Hemoglobin ≥90 g\u002FL\n   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 2.5 × upper limit of normal(ULN) (or ≤ 5 × ULN if hepatic metastases are present). Total bilirubin ≤ 1.5 × ULN (≤ 3 mg\u002FdL if Gilbert's syndrome)\n   * Serum creatinine ≤ 2.0 × ULN or estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin using the Cockcroft-Gault formula\n10. Capacity to comprehend and comply with protocol requirements, with documented informed consent signed\n11. Contraception agreement for sexually active fertile participants and partners to use medically accepted methods during the study and continue for 5 months after last treatment\n12. Negative pregnancy status at screening for women of childbearing potential\n\nSTEP1: At 12-Month Evaluation\n\n1. Patient met all eligibility criteria outlined above\n2. Patient must receive 12 months (±1m) of first line PD-1\u002FPD-L1 ICI + VEGFR-TKI therapy, without permanent discontinuation of both agents due to unmanageable toxicity\n3. Patient must have completed an CD70-targeted immuno-PET\u002FCT scan at 12m (±1m) from start of initial therapy\n4. Patients must meet one of the following criteria:\n\n   * Eligible for treatment discontinuation: For CD70-Positive Lesions: Sustained Disease Control (Complete Response \\[CR\\], Partial Response \\[PR\\], or Stable Disease \\[SD\\]) on CT for ≥ 12 weeks per RECIST 1.1, AND achieved Complete Metabolic Response (CMR) or Partial Metabolic Response (PMR) on CD70 immuno-PET\u002FCT per PERCIST 1.0 criteria; For CD70-Negative Lesions (If present at baseline): Must achieve a deep anatomical response, defined as Complete Response (CR) or Partial Response (PR) on CT, maintained for ≥ 12 weeks per RECIST 1.1\n   * Treatment continuation: not meeting criteria above\n\nExclusion Criteria:\n\nSTEP0: At Treatment Initiation\n\n1. Prior systemic therapy for advanced RCC\n2. Poor risk as per International Metastatic RCC Database Consortium (IMDC) criteria\n3. Karnofsky Performance Status (KPS) \\\u003C70%\n4. Inadequate organ and bone marrow function\n5. Active brain metastases or leptomeningeal disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) who are clinically stable without progression prior to treatment\n6. Concurrent or prior invasive malignancies within the past 5 years, except adequately treated in situ\u002Fsuperficial cancers (e.g., non-melanoma skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix\u002Fbreast)\n7. Presence of uncontrolled major comorbidities or recent severe illnesses within 6 months, including but not limited to: uncontrolled hypertension, clinically significant cardiovascular disease, GI disorders with high risk of perforation\u002Ffistula, significant hematuria, hematemesis, hemoptysis, major bleeding history, severe active infections (including active HIV, HBV, or HCV), or severe autoimmune diseases (e.g., systemic lupus erythematosus, immune pneumonitis)\n8. Life expectancy \\\u003C 6 months\n9. Known allergy or hypersensitivity to the CD70 imaging agent or any of its excipients\n10. Severe hepatic or renal insufficiency, or inability to tolerate PET\u002FCT examination\n11. Medical\u002Fpsychiatric\u002Fsocial conditions compromising protocol compliance\n12. Pregnancy, lactation, or refusal of contraception during and for 5 months post-treatment\n\nSTEP1: At 12-Month Evaluation\n\n1. Failure to complete 12 months(±1m) of first-line PD-1\u002FPD-L1 + VEGFR-TKI therapy due to unmanageable toxicity or disease progression\n2. Failure or inability to undergo CD70-targeted immuno-PET\u002FCT scan at the 12-month evaluation timepoint\n3. Unacceptable clinical deterioration or investigator discretion indicating that a treatment holiday is not in the best interest of the patient",{"count":61,"type":20},75,[63],"PHASE2","The purpose of this study is to evaluate the safety and feasibility of a treatment holiday strategy directed by CD70-targeted immuno-PET\u002FCT in patients with metastatic clear cell renal cell carcinoma (mccRCC). Specifically, the study aims to assess whether patients who achieve both anatomical disease control and metabolic response after 12 months of first-line PD-1\u002FPD-L1 ICI + VEGFR-TKI combination therapy can safely pause their treatment, improve quality of life without compromising therapeutic efficacy.",[26],[26,67,68],"CD70-Targeted Immuno-PET\u002FCT","Treatment Holiday","RECRUITING","2026-06-16",{"date":72,"type":43},"2026-06-18",{"date":70,"type":43},{"date":75,"type":20},"2029-08-10",{"name":77,"class":78},"Jinling Hospital, China","OTHER",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":105},"100622424","phase-3-adding-biotherapy-or-placebo-to-standard-treatment-for-advanced-kidney-cancer-100622424","NCT07383441","Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer","Phase III Double Blinded Trial of Immune-Based Therapy With a Live Biotherapeutic MO-03 or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma [BioFront Trial]","Inclusion Criteria:\n\n* Participants must have histologically confirmed renal cell carcinoma (RCC) with clear cell component that is advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC at the time of registration on study\n* Participants must have measurable\u002Fevaluable disease by RECIST 1.1 criteria. Participants with only bone metastases or only pleural effusions are considered evaluable disease and are eligible\n* Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease must not require immediate central nervous system (CNS) specific treatment at the time of study registration or anticipated treatment during the first cycle of therapy\n* Participants must not be currently enrolled or plan to participate in treatment studies while enrolled on this study\n* Participants must not plan to take any over the counter probiotic supplements at time of study registration and while on protocol treatment\n\n  * NOTE: Vitamin and electrolyte or mineral supplements are permitted\n* Participants must not have had prior systemic therapy for advanced or metastatic RCC or any treatment with immune based combination therapy\n\n  * NOTE: Participants can have prior neo\u002Fadjuvant treatment with an anti-PD-1, anti-PD-L1, and\u002For anti-CTLA-4 antibody or other therapies for any current or prior malignancy if \\> 12 months prior to registration\n* Participants must not be receiving steroid replacement therapy for adrenal insufficiency greater than 50 mg daily of hydrocortisone or prednisone equivalent dose at the time of registration\n* Participants must not require the use of systemic corticosteroids \\> 10 mg\u002Fday of prednisone or its equivalent for any reason other than replacement therapy for adrenal insufficiency\n* Participants must not have received any systemic antibiotics within 7 days prior to registration\n\n  * NOTE: Uncontrolled infections must be completely resolved\n* Participants must be ≥ 18 years old at the time of registration\n* Participants must have a Zubrod performance status 0-2 within 28 days of registration\n* Participants must be able to safely receive at least one of the standard of care regimens, per the current Food and Drug Administration (FDA)-approved package inserts, treating investigator's discretion, and institutional guidelines\n\n  * NOTE: Participants with favorable risk as defined by the International Metastatic RCC Database Consortium (IMDC) must plan to receive one of the TKI+ immunotherapy treatment combinations. They are not able to receive regimen 1 (ipilimumab + nivolumab) for this study\n* Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications\n* Participants must have serum creatinine ≤ 2 x ULN (upper limit of normal). This specimen must have been drawn and processed within 28 days prior to registration\n* Hemoglobin ≥ 8 g\u002FdL (within 28 days prior to registration)\n* Leukocytes ≥ 3 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Absolute neutrophil count ≥ 1.5 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Platelets ≥ 100 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Total bilirubin ≤ institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to registration) Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 3 x institutional ULN (\\\u003C 5 x institutional ULN if liver metastases are present) (within 28 days prior to registration)\n* Participants must have alkaline phosphate measured as a part of the liver function assessment within 28 days prior to registration\n* Participants must have albumin corrected calcium measured within 28 days prior to registration\n* Participants with a history human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load on the most recent test results obtained within 6 months prior to registration\n* Participants with a history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration\n* Participants must not have uncontrolled blood pressure and hypertension within 28 days prior to registration\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not have any known history of an autoimmune disease that prohibits the use of immune checkpoint therapy\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* Participants must be offered the opportunity to participate in specimen banking\n* Participants who have the ability to complete questionnaires in English or Spanish must be offered the opportunity to participate in the patient-reported outcome study\n* NOTE: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations",{"count":87,"type":20},718,[89],"PHASE3","This phase III trial compares the effect of adding live biotherapy, MO-03, to standard of care (SOC) immunotherapy, including ipilimumab, nivolumab, axitinib, pembrolizumab, cabozantinib, and lenvatinib, to SOC immunotherapy alone in treating patients with clear cell renal cell cancer that may have spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started to other places in the body (metastatic). Studies have shown that gut health (the gut microbiome) may impact the effectiveness of immunotherapy. The microbiome includes all of the bacteria and organisms naturally found in the digestive tract. MO-03, a type of biotherapy, contains material from living organisms that may help keep the digestive tract healthy and may help to increase the effect of immunotherapy. Immunotherapy with monoclonal antibodies, such as ipilimumab, nivolumab, pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Axitinib, cabozantinib, and lenvatinib are a type of angiogenesis inhibitor and tyrosine kinase inhibitor (TKI) that block certain proteins which may help keep tumor cells from growing and may also help prevent the growth of new blood vessels that tumors need to grow. Adding MO-03 to SOC immunotherapy may be more effective than SOC immunotherapy alone in treating patients with advanced or metastatic clear cell renal cell cancer.",[92,26,93,94],"Advanced Clear Cell Renal Cell Carcinoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","2026-06-09",{"date":97,"type":43},"2026-06-11",{"date":99,"type":43},"2026-06-05",{"date":101,"type":20},"2034-01-31",{"name":103,"class":104},"SWOG Cancer Research Network","NETWORK",41,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":51},"100632180","phase-2-vsv-ifn-nis-with-ipilimumab-and-nivolumab-for-the-treatment-of-advanced-or-metastatic-clear-cell-renal-cell-carcinoma-100632180","NCT07510334","VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma","Phase 2 Clinical Evaluation of Combination Immunotherapy for Renal Cell Carcinoma","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Disease Characteristics:\n\n  * Histological confirmation of advanced (not amenable to curative surgery or radiation therapy) or metastatic \\[American Joint Committee on Cancer (AJCC) version 8 Stage IV\\] renal cell carcinoma (RCC) with a clear cell component, including all International Metastatic RCC Database Consortium (IMDC) risk categories (favorable, intermediate, and poor risk) allowed\n* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\n\n  * NOTE: Liver lesions that have been previously embolized (bland embolization, chemo- or radio-embolization) or have undergone percutaneous thermoablation are not eligible as target lesions. Tumor lesions in a previously irradiated area are not considered measurable disease; disease that is measurable by physical examination only is not eligible\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2\n* Hemoglobin ≥ 9.0 g\u002FdL (obtained ≤ 15 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 15 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)\n* Prothrombin time (PT)\u002Finternational normalization ratio (INR)\u002Factivated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)\n* Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR creatinine clearance ≥ 50 ml\u002Fmin using the chronic kidney disease epidemiology (CKD-EPI) creatinine equation (per National Kidney Foundation) (obtained ≤ 15 days prior to registration)\n\n  * NOTE: See calculator at National Kidney Foundation website here: https:\u002F\u002Fwww.kidney.org\u002Fprofessionals\u002Fkdoqi\u002Fgfr\\_calculator\n* Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only\n* Provide written informed consent\n* Willingness to provide mandatory blood specimens for correlative research\n* Willingness to provide mandatory tissue specimens for correlative research\n* Willing to return to Mayo Clinic for follow-up (during the active monitoring phase of the study)\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic and teratogenic effects of which on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception\n* Prior treatment for advanced or metastatic RCC \\[American Joint Committee on Cancer (AJCC) Stage IV\\]\n* History of portal vein thrombosis involving more than intrahepatic portal vein branches: thrombosis of the right or left portal vein branch or the bifurcation, partial or complete obstruction of the portal vein trunk\n\n  * NOTE: Level 0 or 1 tumor thrombus remain eligible; Level 2, 3, of 4 tumor thrombus related to the primary kidney tumor are ineligible\n* Has received a live vaccine ≤ 30 days prior to registration\n\n  * NOTE: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are NOT allowed\n* Any of the following prior therapies:\n\n  * Surgery ≤ 3 weeks prior to registration\n  * Chemotherapy ≤ 2 weeks prior to registration\n  * Radiation therapy ≤ 2 weeks prior to registration\n  * Therapy in the first-line setting for advanced or metastatic RCC\n  * Adjuvant immunotherapy during which or in the ≤ 6 months immediately following, relapse or disease progression has occurred\n* New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias \\[atrial fibrillation or supraventricular tachycardia (SVT)\\]\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  * dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy\n  * or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Current immunodeficiency or immunosuppression and receiving systemic corticosteroids at \\> 10mg\u002Fday prednisone or equivalent ≤ 1 week prior to registration.\n\n  * NOTE: Inhaled steroids for pulmonary disease are permitted\n* Known history of the following:\n\n  * Suspected active organ-threatening autoimmune disease including, but not limited to, inflammatory bowel disease, autoimmune hepatitis, lupus, or pneumonitis which can flare while receiving immune checkpoint inhibitor (ICI) treatment.\n\n    * NOTE: Patients with well-controlled or clinically inactive autoimmune diseases are eligible\n  * Non-infectious pneumonitis that required steroids, current pneumonitis, carcinomatous meningitis, or interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity\n* Known or ongoing illness or infection including:\n\n  * Any active Grade 3 or higher \\[per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version (v) 5.0\\] viral, bacterial, or fungal infection ≤ 2 weeks of registration.\n  * Acute hepatitis B (HBV) or acute hepatitis C virus (HCV)\n\n    * NOTE: Patients with chronic HBV or HCV with adequate liver function per inclusion criteria are still eligible\n  * Patients known to be HIV positive and currently receiving antiretroviral therapy\n  * Known history of active tuberculosis (TB) (bacillus tuberculosis)\n  * Uncontrolled hypertension and\u002For diabetes\n  * Clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease requiring hospitalization ≤ 3 months prior to treatment)\n* Receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, radiotherapy, or any other investigational agent or therapy considered investigational (used for a non-Food and Drug Administration (FDA) approved indication and in the context of a research investigation)\n* Known concurrent malignancy that is progressing or requires active treatment\n\n  * EXCEPTIONS: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in-situ cervical cancer that has been treated with curative intent, prostate cancer confined to the prostate gland with Gleason score ≤ 6, as well as any cancer treated with curative intent or any prior cancer with a disease-free interval of ≥ 3 years\n* History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias",{"count":5,"type":20},[63],"This phase II trial tests adding VSV-IFNβ-NIS to standard of care ipilimumab and nivolumab for the treatment of clear cell renal cell carcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). A virus modified in the laboratory, such as VSV-IFNβ-NIS, may be able to kill tumor cells without damaging normal cells. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving VSV-IFNβ-NIS with ipilimumab and nivolumab may be effective for the treatment of advanced or metastatic clear cell renal cell carcinoma.",[92,26,93,94],"2026-06-03",{"date":99,"type":43},{"date":120,"type":43},"2026-04-21",{"date":122,"type":20},"2033-08-01",{"name":124,"class":78},"Mayo Clinic",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":137,"conditions":138,"keywords":139,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100576288","phase-2-radiopharmaceutical-treatment-of-advanced-kidney-cancer-100576288","NCT06783348","Radiopharmaceutical Treatment of Advanced Kidney Cancer","Phase II Trial Evaluating the Efficacy of 177Lutetium-PSMA-617 Treatment in Patients With Metastatic Clear Cell Renal Carcinoma Cell With Progressive Disease on First-line or Second-line Systemic Treatment","RENALUT","Inclusion Criteria:\n\nPRE-SCREENING\n\n* Histologically proven ccRCC. Sarcomatoid component is allowed.\n* Adult patients ≥18 years old.\n* Has progressed on or after ≥1-line prior systemic therapy approved in the metastatic setting. Prior treatment must include an anti-programmed death-1 (receptor) \\[PD-1\\]\u002Fprogrammed death-ligand 1 (PD-L1) therapy +\u002F- ipilimumab and a VEGFR-TKI.\n* Written pre-screening informed consent according to ICH\u002FGCP and local regulations.\n\nSCREENING\n\n* Patients with at least one PSMA-positive metastatic lesion, and no exclusionary PSMA-negative lesions, with positive lesions defined as those with a maximum standardized uptake value (SUVmax) greater than the mean standardized uptake value (SUVmean) of liver background.\n* Measurable disease by RECIST 1.1 criteria.\n* Patients with adequate blood tests (Absolute neutrophil count \\> 1.5 x 109\u002FL, haemoglobin \\> 9.0 g\u002FdL, platelet count \\> 100,000\u002FµL, estimated glomerular filtration rate (GFR) ≥ 40 ml\u002Fmin by CKD-EPI formula, total bilirubin ≤ 1.5 x ULN. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastases).\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to registration. A positive urine pregnancy test result must immediately be confirmed using a serum test. A pregnancy test is to be reported within 7 days prior to the first dose of the study treatment.\n\nNote: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrhoeic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression, or other reasons.\n\n* Patients of childbearing \u002F reproductive potential should use adequate birth control measures during the study treatment period and for at least 14 weeks after the last dose of treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Such methods include:\n\n  * Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)\n  * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)\n  * Intrauterine device (IUD)\n  * Intrauterine hormone-releasing system (IUS)\n  * Bilateral tubal occlusion\n  * Vasectomized partner\n  * Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)\n  * Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 3 months after the last study treatment.\n* Before patient's enrolment, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations. This includes consent to comply to recommended radioprotection precautions during study.\n\nExclusion Criteria:\n\n* Patient with RCC in a single kidney.\n* Patients with PSMA-negative lesions (defined as PSMA uptake equal to or lower than that of liver parenchyma) in any lymph node with a short axis of at least 15 mm, in any metastatic solid-organ lesions with a short axis of at least 1.0 cm, or in any metastatic bone lesion with a soft-tissue component of at least 1.0 cm in the short axis. Patients with any PSMA-negative metastatic lesion meeting these criteria are ineligible.\n* Other malignancy that is expected to interfere with the treatment or results of this study, such as prostate cancer.\n* Patient with active uncontrolled or symptomatic central nervous system (CNS metastases).\n\nNote: patients treated previously with radiotherapy and\u002For surgery resulting in controlled\u002Fasymptomatic CNS disease are allowed.\n\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the in the trial.\n* Known contraindication to imaging tracer or any product of contrast media.","100 Years",{"count":135,"type":20},48,[63],"Background This study is for adults with advanced kidney cancer that has spread to other parts of the body and has continued to progress despite treatment with immunotherapy and targeted therapy. Unfortunately, treatment options at this stage of the disease are limited. The existing treatments' ability to work against cancer has not been fully looked into.\n\nRationale The goal of this study is to examine if a new drug treatment called 177Lutetium-PSMA-617, hereafter referred as 177Lu-PSMA-617, which holds the active ingredient 177Lutetium-PSMA and has been used as a standard treatment for advanced prostate cancer since December 2022, can also help treat advanced kidney cancer.\n\nThe drug 177Lu-PSMA-617 is being tested as an experimental treatment that targets a specific protein on cancer cells. This protein, known as prostate-specific membrane antigen (PSMA), is present on the surface of kidney cancer cells. Therefore, before the treatment begins, participants will undergo a PET (positron-emission tomography) scan to check if their kidney cancer cells express high levels of PSMA. This scan uses a small amount of radioactive material (in the form of 177Lutetium) to visualize the presence of PSMA on the cancer cells. Only participants who test positive for PSMA can take part in the study. In this approach, PSMA serves two purposes. First, it helps assess whether the cancer expresses this protein and allows 177Lu-PSMA-617 to specifically target and attach to the cancer cells. Second, 177Lu-PSMA-617 delivers a small amount of radiation directly to the tumour, which helps kill cancer cells while minimizing damage to normal cells. This type of treatment is known as a radiopharmaceutical.\n\nObjective The primary aims are to find out if 177Lu-PSMA-617 is useful against kidney cancer and to assess its safety. Throughout the study, participants will undergo several imaging assessments to check their disease and response to treatment.\n\nThe study also includes the collection of tissue samples. Together with the information collected from the imaging assessments, this will allow further research into markers that may lead to earlier detection of tumour spread or help identify individuals who may benefit more from treatment with 177Lu-PSMA-617.\n\nTreatment All participants will receive 177Lu-PSMA-617 through an intravenous injection at a standard dose of 7,400 MBq (megabecquerel: a measure of radioactivity). Treatments will be administered approximately every six weeks, for a maximum of six times.\n\nBlood tests are done before and during treatment to check the participant's health and to detect any early side effects from the treatment. Different types of scans are performed before, during, and after 177Lu-PSMA-617 administration to check how well the treatment is working. After treatment ends, follow-up visits will be scheduled every six weeks during the first year. In the second year, your doctor will decide how often you need to come in for visits. These appointments are important for monitoring how the body continues to respond to the treatment. The entire study period will last approximately two years from the time of study entry.\n\nParticipants\n\nThe study will include approximately 56 participants who will be tested for PSMA expression, to obtain a minimum of 48 participants expressing PSMA entering the study. To qualify, participants must:\n\n* Be diagnosed with advanced kidney cancer previously treated with immunotherapy and targeted therapy.\n* Test positive for PSMA on a PET scan.\n* Be generally healthy and able to perform daily activities.\n* Be at least 18 years of age.\n\nBenefit-risk analysis The drug 177Lu-PSMA-617 has proven to work well in treating advanced prostate cancer and could be a promising new treatment possibility for kidney cancer, although this has not yet been shown. By joining this study, participants will contribute to valuable research to better understand kidney cancer and improve treatment options for future patients. Participating in this study offers a chance to try a new treatment, which might help people with advanced kidney cancer live longer and prevent the disease from getting worse, especially for those who have limited treatment options left after immunotherapy and targeted therapy.\n\nWith all new treatments, there are possible risks and side effects associated with them. Side effects of the drug 177Lu-PSMA-617 may include feeling tired, nausea, dry mouth, loss of appetite, and changes in blood cells. While not all side effects are known yet, the study team will carefully follow participants for any side effects during and after treatment. It is important to understand that while the study is being done to provide new information, there are still some questions on the treatment's safety and how well it will work.",[26],[140],"renal cancer","2026-06-02",{"date":143,"type":43},"2026-06-04",{"date":145,"type":43},"2026-04-07",{"date":147,"type":20},"2029-01-01",{"name":149,"class":104},"European Organisation for Research and Treatment of Cancer - EORTC",2,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":21,"phases":160,"briefSummary":161,"conditions":162,"keywords":163,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":177},"100593844","phase-3-study-of-casdatifan-and-cabozantinib-versus-placebo-and-cabozantinib-in-patients-with-advanced-clear-cell-renal-cell-carcinoma-100593844","NCT07011719","Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma","A Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma","Inclusion Criteria:\n\n* Unresectable and measurable locally advanced or metastatic renal cell carcinoma with a primary clear cell component.\n* A Karnofsky Performance Status (KPS) score ≥ 80%\n* At least 1 target lesion measurable by computed tomography\u002Fmagnetic resonance imaging per RECIST 1.1, not within a field of prior radiation therapy.\n* Adequate organ and marrow function, ≤ 1 week prior to randomization.\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.\n\nExclusion Criteria:\n\n* Received prior treatment with a HIF-2α inhibitor or cabozantinib.\n* Other prior malignancy active within the previous year except for locally curable cancers that have been apparently cured.\n* Ongoing clinically significant toxicities related to any prior anticancer treatment, or toxicities Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) regardless of relatedness to prior anticancer therapies.\n* Uncontrolled or poorly controlled hypertension, defined as a sustained blood pressure \\> 150 mmHg systolic or \\> 90 mmHg diastolic despite optimal antihypertensive treatment.\n* History of leptomeningeal disease or spinal cord compression.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":159,"type":20},720,[89],"The purpose of the study is to evaluate the progression-free survival (PFS) of casdatifan versus placebo when each is given in combination with cabozantinib in adult patients with confirmed advanced or metastatic clear cell Renal Cell Carcinoma who have experienced progression on or after prior anti-PD-1 or anti-PD-L1 immunotherapy.",[26,92],[164,26,92,165,166,167,168],"Casdatifan","Kidney Cancer","PEAK-1","AB521","ccRCC","2026-05-29",{"date":141,"type":43},{"date":172,"type":43},"2025-09-08",{"date":174,"type":20},"2030-12",{"name":176,"class":50},"Arcus Biosciences, Inc.",118,{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":21,"phases":187,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":150},"100602835","phase-1-immunotherapy-nivolumab-and-ipilimumab-with-and-without-a-live-biotherapeutic-product-exl01-for-the-treatment-of-metastatic-renal-cell-cancer-100602835","NCT07128680","Immunotherapy (Nivolumab and Ipilimumab) With and Without a Live Biotherapeutic Product (EXL01) for the Treatment of Metastatic Renal Cell Cancer","A Randomized Study of Nivolumab and Ipilimumab With and Without EXL01 in First-Line Treatment of Metastatic Renal Cell Carcinoma (mRCC)","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 years at time of signing informed consent\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Life expectancy \\> 3 months\n* Histologically confirmed renal cell carcinoma with clear cell renal cell carcinoma component with or without sarcomatoid component\n* Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer \\[AJCC\\] stage IV) renal cell carcinoma with any disease risk disease by International Metastatic RCC Database Consortium (IMDC) criteria (good-, intermediate- or poor-risk)\n* No prior systemic therapy for RCC with the following exception:\n\n  * One prior adjuvant or neoadjuvant therapy for completely resectable RCC if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy, provided that the patient has fully recovered from acute toxic effects to prior anti-cancer therapy\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement\n* Platelets ≥ 100,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Hemoglobin ≥ 9g\u002FdL\n\n  * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (except for subjects with Gilbert Syndrome, who may have total bilirubin up to 3.0 mg\u002FdL)\n* Aspartate aminotransferase (AST) ≤ 3.0 x ULN\n* Alanine aminotransferase (ALT) ≤ x ULN\n* Creatinine clearance of ≥ 30 mL\u002Fmin per 24-hour urine test or the Cockcroft-Gault formula or serum creatinine \\\u003C 1.5 x upper limit of normal (ULN)\n* If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN\n* If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants\n* If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN\n* If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants\n* If seropositive for HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV), nucleic acid quantitation must be performed. Viral load must be undetectable. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Meets other institutional and federal requirements for infectious disease titer requirements\n\n  * Note infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test within 72 hours of study start\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 5 months after the last dose of nivolumab or ipilimumab for women with childbearing potential, and 5 months after the last dose of nivolumab or ipilimumab for men. For EXL01, female participants should continue contraception for 30 days after the last dose\n* Female subjects of childbearing potential must not be pregnant at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes. In addition, females \\\u003C 55 years-of-age must have a serum follicle stimulating \\[FSH\\] level \\> 40 mIU\u002FmL to confirm menopause).\n\n  * Note: Documentation may include review of medical records, medical examinations, or medical history interview by study site\n\nExclusion Criteria:\n\n* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways\n* Current use, or intent to use probiotics, prebiotics, bacterial fortified foods and other natural supplements ≤ 2 week prior to treatment initiation and during the period of treatment\n* Any botanical preparation (e.g. herbal supplements or traditional Chinese medicines) intended to treat the disease under study or provide supportive care\n* Fecal microbiota transplant within 3 months prior to screening\n\n  * Note: Patients must have recovered adequately from the toxicity and\u002For complications from the treatment prior to starting study intervention\n* Patients requiring chronic antibiotic therapy at the time of study enrollment\n* Unstable cardiac disease as defined by one of the following:\n\n  * Cardiac events such as myocardial infarction (MI) within the past 6 months\n  * NYHA (New York Heart Association) heart failure class III-IV\n  * Uncontrolled atrial fibrillation or hypertension\n* Active interstitial lung disease (ILD)\u002Fpneumonitis or history of ILD\u002Fpneumonitis requiring treatment with systemic steroids\n* Known medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results\n* Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment\n* Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Patients must have recovered adequately from the toxicity and\u002For complications from the treatment prior to starting study intervention\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis). Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment\n* Administration of a live, attenuated vaccine within 30 days before first dose of study treatment\n* The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  * Any condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days before first dose of study treatment\n\n    * Note: Inhaled, intranasal, intra-articular, or topical steroids are permitted. Adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent are permitted. Transient short-term use of systemic corticosteroids for allergic conditions (e.g., contrast allergy) is also allowed\n  * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan\n* Active inflammatory intestinal disease (Crohn disease, Hemorrhagic recto-colitis, coeliac disease) or any serious chronic intestinal disease with uncontrolled diarrhea\n* Known positive test for tuberculosis infection where there is clinical or radiographic evidence of active mycobacterial infection\n* Major surgery within 28 days (4 weeks) prior to first dose of study treatment\n\n  * Note: Participants who had surgery \\> 4 weeks prior to screening must have recovered adequately from any toxicity and\u002For complications from the surgery or trauma prior to starting study intervention\n* Malabsorption syndrome\n* Uncompensated\u002Fsymptomatic hypothyroidism\n* Moderate to severe hepatic impairment (Child-Pugh B or C)\n* Requirement for hemodialysis or peritoneal dialysis\n* History of solid organ or allogenic stem cell transplant\n* Other clinically significant disorders that would preclude safe study participation.\n\n  * Any active, known, or suspected autoimmune disease will be excluded, with the following exceptions:\n\n    * Type 1 diabetes mellitus.\n    * Hypothyroidism only requiring hormone replacement.\n    * Skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment.\n    * Conditions not expected to recur in the absence of an external trigger\n* Gastrointestinal (GI) obstruction, poor oral intake, or difficulty in taking oral medication or difficulties in swallowing; nasogastric tubes are not permitted or unwillingness or inability to receive IV administration\n* Known history or newly diagnosed GI parasitic infection within 3 months prior to screening. Patients must have recovered adequately from the toxicity and\u002For complications from the treatment prior to starting study intervention\n* Previously identified allergy or hypersensitivity to components of the study treatment formulations or history of severe infusion-related reactions to monoclonal antibodies. Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption are also excluded\n* A patient with a known serious hypersensitivity to any component of the drug formulation for EXL01, or any other live biotherapeutic product (LBP), should not receive EXL01\n* Hypersensitivity to soy products\n* Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":186,"type":20},33,[188],"PHASE1","This phase I trial tests the safety and effectiveness of nivolumab and ipilimumab with and without EXL01 for the treatment of renal cell cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. EXL01 is a live biotherapeutic product containing a strain of bacteria called Faecalibacterium prausnitzii. It may enhance a patient's response to treatment with immune checkpoint inhibitors like nivolumab and ipilimumab by altering the composition of the bacteria in the gut. Adding EXL01 to treatment with nivolumab and ipilimumab may be safe and more effective than giving nivolumab and ipilimumab alone.",[92,191,26,192,93,94],"Advanced Sarcomatoid Renal Cell Carcinoma","Metastatic Sarcomatoid Renal Cell Carcinoma","2026-05-07",{"date":195,"type":43},"2026-05-11",{"date":197,"type":43},"2026-03-23",{"date":199,"type":20},"2028-08-25",{"name":201,"class":78},"City of Hope Medical Center",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":21,"phases":211,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":51},"100638059","phase-2-zanzalintinib-and-mo-03-for-the-treatment-of-metastatic-renal-cell-cancer-after-progression-on-immunotherapy-100638059","NCT07578025","Zanzalintinib and MO-03 for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy","Phase 2, Single-Arm Trial of Zanzalintinib (XL092) With MO-03 (CBM588 Capsule) in Patients With Metastatic Renal Cell Carcinoma (mRCC) After Progression to Immunotherapy","Inclusion Criteria:\n\n* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 years\n* Gender: Males and females are eligible\n* Any ethnicity or race\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Histologically confirmed renal cell carcinoma with a clear-cell histology\n* Patients must have received one or two prior lines of systemic therapy for metastatic disease, which must include prior treatment with a checkpoint inhibitor and cabozantinib (not necessarily in the same line). Prior use of hypoxia-inducible factor (HIF) inhibitors or other tyrosine kinase inhibitors (TKIs) other than cabozantinib are not allowed\n* Measurable metastatic disease by RECIST v 1.1 criteria\n* Recovery to baseline or ≤ grade 1 severity (CTCAE v 6.0) from adverse events (AEs), including immune-related adverse events (irAEs), related to any prior treatments, unless AE(s) are clinically nonsignificant and\u002For stable on supportive therapy (e.g., physiological replacement of corticosteroid). Low-grade or controlled toxicities such as alopecia, ≤ grade 2 hypomagnesemia, ≤ grade 2 neuropathy are permitted)\n* White blood cell (WBC) \\> 2,000\u002Fmm\\^3 (to be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)\n\n  * NOTE: Growth factor is not permitted within 14 days of absolute neutrophil count (ANC) assessment unless cytopenia is secondary to disease involvement\n* Neutrophils ≥ 1,500\u002Fmm\\^3 (to be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)\n\n  * NOTE: Growth factor is not permitted within 14 days of absolute neutrophil count (ANC) assessment unless cytopenia is secondary to disease involvement\n* Platelets ≥ 100,000\u002Fmm\\^3 (to be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)\n\n  * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Hemoglobin ≥ 9g\u002FdL (to be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)\n\n  * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (except for subjects with Gilbert Syndrome, who may have total bilirubin up to 3.0 mg\u002FdL) (to be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)\n* Aspartate aminotransferase (AST) ≤ 3.0 x ULN (except for subjects with Gilbert Syndrome, who may have total bilirubin up to 3.0 mg\u002FdL) (to be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)\n* Alkaline phosphatase (ALP) ≤ 3.0 x ULN. For subjects with documented bone metastasis ALP ≤ 5 x ULN (to be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)\n* Creatinine clearance ≥ 40 mL\u002Fmin the Cockcroft-Gault formula (to be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)\n* If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN. If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants (to be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)\n* If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.2 x ULN, INR ≤ 1.5. If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants (to be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)\n* QT interval corrected by Bazett's formula (QTcB) ≤ 480 ms\n\n  * Note: To be performed within 28 days prior to day 1 of protocol therapy\n* If seropositive for HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV), nucleic acid quantitation must be performed. Viral load must be undetectable. HIV-infected, chronic carriers of HBV, and chronic carriers of HCV on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Meets other institutional and federal requirements for infectious disease titer requirements\n\n  * Note: Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Sexually active fertile subjects and their partners must agree to use highly effective method of contraception during the course of the study and for the following durations after the last dose of treatment (whichever is later). An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods, through 186 days after the last dose of zanzalintinib for women of childbearing potential (WOCBP) or through 96 days after the last dose of zanzalintinib for men\n* Female subjects of childbearing potential must not be pregnant at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes. In addition, females \\\u003C 55 years-of-age must have a serum follicle stimulating hormone \\[FSH\\] level \\> 40 mIU\u002FmL to confirm menopause).\n\n  * Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff\n\nExclusion Criteria:\n\n* Prior treatment with zanzalintinib\n* Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment\n* Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment\n\n  * Note: Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment.\n  * Note: Base of skull lesions without definitive evidence of dural or brain parenchymal involvement are allowed\n* Known medical condition (e.g., chronic diarrhea or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results\n* Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin inhibitors ) and platelet inhibitors (e.g., clopidogrel).Allowed anticoagulants are the following:\n\n  * Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n  * Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n\n    * Note: Subjects must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer\n* Any complementary medications (e.g., herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment\n* The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  * Unstable or deteriorating cardiovascular disorders:\n\n    * Congestive heart failure New York Heart Association Class 3 or 4, class 2 or higher, unstable angina pectoris, new-onset angina, serious cardiac arrhythmias (e.g., ventricular flutter, ventricular fibrillation, Torsades de pointes).\n    * Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 140 mm Hg systolic or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment.\n    * Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction, or other clinically significant arterial thrombotic and\u002For ischemic event within 6 months before first dose of study treatment.\n    * Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous events within 3 months before first dose of study treatment.\n\n      * Note: Subjects with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n      * Note: Subjects who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the Principal Investigator\n* Prior history of myocarditis.\n\n  * Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n\n    * Tumors invading the GI-tract from external viscera.\n    * Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis.\n    * Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months before first dose unless cause of obstruction is definitively managed and subject is asymptomatic.\n    * Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose.\n\n      * Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment\n* Known gastric or esophageal varices\n* Ascites, pleural effusion, or pericardial fluid requiring drainage in last 4 weeks\n* Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study treatment\n* Symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed)\n* Lesions invading major blood vessel including, but not limited to, inferior vena cava, pulmonary artery, or aorta.\n\n  * Note: Subjects with intravascular tumor extension (e.g., tumor thrombus in renal vein or inferior V. cava) may be eligible following Principal Investigator approval\n* Other clinically significant disorders that would preclude safe study participation\n\n  * Active infection requiring systemic treatment. Note: Prophylactic antimicrobial treatments (antibiotics, antimycotic, antiviral) are allowed.\n  * Known infection with acute or chronic hepatitis B or C, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness except for subjects meeting all of the following criteria:\n\n    * (1) Chronic carriers of HBV infection (hepatitis B surface antigen \\[HBsAg\\]-positive, anti-hepatitis B core antibody \\[anti-HBc\\]-positive) who have undetectable HBV deoxyribonucleic acid (DNA) and are on stable suppressive antiviral therapy.\n    * (2) Individuals with prior HCV infection who have completed curative antiviral treatment and achieved undetectable HCV viral load.\n    * (3) Chronic carriers of HCV infection who are on stable suppressive antiviral therapy and have undetectable HCV viral load.\n    * (4) HIV-infected patients on stable anti-retroviral therapy with CD4+ T cell count ≥ 200\u002FµL; and) an undetectable viral load. \\*\\*\\* Note: HIV testing will be performed at screening if and as required by local regulation.\n\n      * Note: To be eligible, participants taking CYP inhibitors (e.g., zidovudine, ritonavir, cobicistat, didanosine) or CYP3 inducers (efavirenz) must change to a different regimen not including these drugs 7 days prior to initiation of study treatment. Anti-retroviral therapies (ART) must have been received for at least 4 weeks prior to the first dose.\n      * Note: CD4+ T cell counts, and viral load are monitored per standard of care by the local health care provider.\n  * Serious non-healing wound\u002Fulcer\u002Fbone fracture.\n\n    * Note: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions.\n  * Malabsorption syndrome.\n  * Pharmacologically uncompensated, symptomatic hypothyroidism.\n  * Moderate to severe hepatic impairment (Child-Pugh B or C).\n  * Requirement for hemodialysis or peritoneal dialysis.\n  * History of solid organ or allogeneic stem cell transplant\n* Major surgery (e.g., GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to first dose of study treatment. Prior laparoscopic surgeries (i.e. nephrectomy) within 4 weeks prior to first dose of study treatment. Minor surgery (e.g., simple excision, tooth extraction) within 5 days before first dose of study treatment. Complete wound healing from major or minor surgery must have occurred at least prior to first dose of study treatment\n\n  * Note: Fresh tumor biopsies should be performed at least 5 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 480 ms within 14 days per electrocardiogram (ECG) before first dose of study treatment.\n\n  * Note: Triplicate ECG evaluations will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility\n* History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent\n* Women who are pregnant or breastfeeding\n* Inability to swallow tablets or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy (PEG) tube\n* Previously identified allergy or hypersensitivity to components of the study treatment formulations\n* Another malignancy that requires active therapy and in the opinion of the Investigator would interfere with monitoring of radiologic assessments of response to Investigational Product, within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6\n* Other conditions, which in the opinion of the Investigator, would compromise the safety of the patient or the patient's ability to complete the study\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":210,"type":20},34,[63],"This phase II trial tests how well zanzalintinib and MO-03 works for the treatment of renal cell cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that is growing, spreading, or getting worse (progression) after receiving immunotherapy. Zanzalintinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. MO-03 is a type of medication called a microbiome-based immunomodulator. It helps control some of the bacteria found in the gut which may make the zanzalintinib more effective. Giving zanzalintinib with MO-03 may be effective for treating metastatic renal cell cancer after progression on immunotherapy.",[26,94],"2026-05-05",{"date":195,"type":43},{"date":217,"type":20},"2026-11-28",{"date":219,"type":20},"2028-06-24",{"name":201,"class":78},{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":21,"phases":230,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":51},"100638080","phase-2-low-dose-reduced-frequency-nivolumab-for-the-treatment-of-unresectable-or-metastatic-cancer-afford-io-trial-100638080","NCT07576725","Low Dose, Reduced Frequency Nivolumab for the Treatment of Unresectable or Metastatic Cancer, AFFORD IO Trial","AFFORD IO: A Phase 2 Trial of Low Dose, Reduced Frequency Nivolumab (Anti-PD-1 Antibody) in Patients With Unresectable or Metastatic Cancer","Inclusion Criteria:\n\n* Participants are eligible if they have one of these histologically confirmed, unresectable or metastatic cancer types listed below, based upon historical responsiveness to anti-PD-(L)1 agents\n\n  * Non-small cell lung cancer (NSCLC) with documented PD-L1 expression (combined positive score \\[CPS\\] ≥ 1) (NOTE: Participants with known driver oncogenic mutations\u002Frearrangements, including EGFR, ALK and ROS-1, will be excluded.)\n  * Head and neck squamous cell carcinoma (HNSCC) with documented PD-L1 expression (CPS ≥ 1)\n  * Clear cell renal cell carcinoma (ccRCC) (NOTE: Other subtypes may be permitted after approval by the Medical Monitor)\n  * Melanoma (cutaneous, acral-lentiginous and mucosal subtypes), and non-melanoma skin cancers, (cutaneous squamous cell carcinoma \\[CSCC\\], basal cell carcinoma \\[BCC\\] and Merkel cell carcinoma \\[MCC\\])\n  * Hodgkin's lymphoma\n  * Urothelial carcinoma\n  * Cervical cancer with documented PD-L1 expression (CPS ≥ 1)\n  * Colorectal cancer with high microsatellite instability (MSI) or mismatch repair deficiency\n  * Kaposi sarcoma (KS) without clinical concern for multicentric Castleman's disease (MCD)\n  * Any cancer type with historical data suggesting an ORR \\> 20% with anti-PD(L)-1 agents (NOTE: All participants in this category must be approved by the Medical Monitor prior to enrollment.)\n* Must have experienced disease progression after or deemed not to be a good candidate for available curative systemic therapy options\n* Presence of at least one measurable tumor, per RECIST v1.1\n* Age 18 or older. (NOTE: Both men and women, and members of all races and ethnic groups are eligible for this trial.)\n* Eastern Cooperative Oncology Group (ECOG) performance score of 0-2\n* Absolute neutrophil count (ANC) ≥ 1.0 × 10\\^9\u002FL\n* Platelet count ≥ 75 × 10\\^9\u002FL\n* Hemoglobin ≥ 9 g\u002FdL (NOTE: Participants may have been transfused)\n* Total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) (or total bilirubin ≤ 2.5 × upper limit of normal \\[ULN\\] in participants with Gilbert's syndrome)\n* Estimated creatinine clearance ≥ 30mL\u002Fmin according to the Cockcroft-Gault formula or according to local institutional standard\n* Must consent to undergo serial research blood draws at study defined timepoints, unless deemed unsafe or not feasible by the treating investigator\n* Must have an ability to understand and provide consent to the institutional review board (IRB)-approved informed consent form (ICF) document(s)\n* Women of childbearing potential must have a negative serum or urine pregnancy test at screening\n* Both male and female participants must be willing to use highly effective contraception, as stipulated in national or local guidelines, throughout the study and for at least 180 days after the last treatment administration, if the risk of conception exists\n\nExclusion Criteria:\n\n* Prior exposure to any immune-checkpoint inhibitor for any reason\n* Residual adverse event(s) from prior therapy grade \\> 1 (National Cancer Institute \\[NCI\\]-Common Terminology Criteria for Adverse Events \\[CTCAE\\] v6.0) that could interfere with study endpoints or put participant safety at risk, as determined by the treating investigator\n* Known active central nervous system (CNS) metastases and\u002For prior history of leptomeningeal cancer involvement\n* Known history of another active malignancy (besides the eligible cancer diagnosis) within the last 3 years from day 1 of nivolumab that could interfere with study endpoints or put participant safety at risk. (NOTE: Exception will be made for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ \\[skin, bladder, cervical, colorectal, breast\\] or low grade prostatic intraepithelial neoplasia or grade 1 prostate cancer. Any other neoplasm, which has been treated adequately and is adjudged by the treating investigator to have a low risk of progression during the study, could be enrolled only after approval from the medical monitor.)\n* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV), defined as follows:\n\n  * Active HBV is defined as a known positive hepatitis B virus surface antigen (HBsAg) result or positive total hepatitis B virus core antibody (anti-HBc) results in the absence of hepatitis B virus surface antibody (anti-HBsAb). (NOTE: When HBsAg is negative and HBcAb is positive, HBV-DNA should be measured. When HBV-deoxyribonucleic acid \\[DNA\\] is negative, this participant could be enrolled with close monitoring of HBV activities.)\n  * Active hepatitis C virus (HCV) is defined as a known positive HCV antibody result and quantitative HCV-ribonucleic acid (RNA) results greater than the lower limits of detection of the assay. (NOTE: Participants who have had definitive treatment for HCV are permitted if HCV-RNA is undetectable.)\n* Known uncontrolled HIV infection. (NOTE: HIV-infected participants may be allowed if all the following criteria are met: CD4 count ≥ 100\u002FμL, viral load less than 200 copies\u002FmL, and clinically stable on antiretroviral therapy \\[ART\\] for at least 3 months.)\n\n  * These participants will be enrolled only after approval from the medical monitor\n* Known active autoimmune disease or an allograft requiring systemic immunosuppression with corticosteroids (\\> 10 mg\u002Fday of prednisone or equivalent) or immunosuppressive drugs within the past 2 years before the first dose of nivolumab. (NOTE: Exceptions will be made for participants with autoimmune conditions such as diabetes type I, vitiligo, psoriasis, hypothyroid or hyperthyroid diseases not requiring immunosuppressive treatment; participants receiving physiologic corticosteroid replacement therapy at doses \\\u003C 10 mg\u002Fday of prednisone or equivalent for adrenal or pituitary insufficiency; participants with a condition such as asthma or chronic obstructive pulmonary disease that requires intermittent use of steroids or those who require brief courses of corticosteroids for prophylaxis \\[e.g., contrast dye allergy\\], nivolumab-related standard premedication, and\u002For treatment of non-serious immune related adverse events. Any other situation must be discussed with the medical monitor for risk\u002Fbenefit assessment.)\n* Immunosuppressed status due to severe uncontrolled diabetes, concurrent uncontrolled hematological malignancy, or other comorbidities\n* Known history of serious, active infections (aside from well-controlled HIV, as per exclusion criterion #6) requiring systemic antimicrobial agents within 14 days before the first dose of nivolumab. (NOTE: Chronic infections such as herpes simplex virus requiring suppressive therapy may be allowed after discussion with the medical monitor for risk\u002Fbenefit assessment.)\n* Known history of clinically significant interstitial lung disease, or active noninfectious pneumonitis\n* Clinically significant (i.e., active) cardiovascular disease such as cerebral vascular accident or myocardial infarction within 6 months prior to first dose of nivolumab, ongoing unstable angina or congestive heart failure (New York Heart Association Classification class II-IV), or serious cardiac arrhythmia that could jeopardize participant safety on the study\n* Receipt of live vaccine(s) within 30 days of planned start of nivolumab. (NOTE: Examples of live vaccines include but are not limited to measles, mumps, rubella, varicella-zoster \\[chickenpox\\], yellow fever, rabies, bacillus Calmette Guerin \\[BCG\\], and typhoid vaccines. Seasonal influenza vaccines for injection are generally killed-virus vaccines and are allowed; however, intranasal influenza vaccines are live, attenuated vaccines and are not allowed.)\n* Known severe acute or chronic medical conditions such as uncontrolled seizure disorder, serious psychiatric illness, or laboratory abnormalities, that may increase the risk associated with study participation or may interfere with the interpretation of study endpoints and, in the judgment of the treating investigator, would make the participant inappropriate for entry into this study\n* Known active tuberculosis (TB). (NOTE: Participants with latent TB will be allowed, provided they are receiving tuberculosis preventive therapy, after approval of the medical monitor.)\n* Known allergy or hypersensitivity to any component of the study drug formulation (including excipients and additives) that could interfere with study endpoints or put participant safety at risk\n* Pregnant or breast-feeding woman",{"count":229,"type":20},50,[63],"This phase II trial studies how well low dose, reduced frequency nivolumab works in treating patients with cancer that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Nivolumab is a type of immune checkpoint inhibitor (ICI). ICIs have revolutionized the treatment of numerous cancers with remarkable improvement in participant outcomes. However, accessibility of ICIs is extremely poor on a global scale, mainly due to high costs. Previous research has suggested that these drugs can be given at lower doses and reduced frequency than their approved dosing regimens, with similar results. Giving nivolumab at a lower dose and less often may help reduce the cost of therapy, improve immunotherapy accessibility, and therefore improve survival outcomes globally.",[233,234,235,236,237,238,239,240,241,26,242,243,244,245,246,247,248,249,250,251,252,253,254,255,93,256,257,258,259,94,260,261,262,263,264,265,266,267,268,269,270,271,272],"Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8","Hodgkin Lymphoma","Kaposi Sarcoma","Metastatic Acral Lentiginous Melanoma","Metastatic Basal Cell Carcinoma","Metastatic Cervical Carcinoma","Metastatic Colorectal Carcinoma","Metastatic Cutaneous Melanoma","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Kaposi Sarcoma","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Malignant Solid Neoplasm","Metastatic Merkel Cell Carcinoma","Metastatic Mucosal Melanoma","Metastatic Skin Squamous Cell Carcinoma","Metastatic Urothelial Carcinoma","Stage III Cervical Cancer AJCC v8","Stage III Colorectal Cancer AJCC v8","Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage III Lung Cancer AJCC v8","Stage IV Cervical Cancer AJCC v8","Stage IV Colorectal Cancer AJCC v8","Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage IV Lung Cancer AJCC v8","Unresectable Acral Lentiginous Melanoma","Unresectable Basal Cell Carcinoma","Unresectable Cervical Carcinoma","Unresectable Clear Cell Renal Cell Carcinoma","Unresectable Colorectal Carcinoma","Unresectable Cutaneous Melanoma","Unresectable Head and Neck Squamous Cell Carcinoma","Unresectable Lung Non-Small Cell Carcinoma","Unresectable Malignant Solid Neoplasm","Unresectable Merkel Cell Carcinoma","Unresectable Mucosal Melanoma","Unresectable Skin Squamous Cell Carcinoma","Unresectable Urothelial Carcinoma","2026-05-01",{"date":275,"type":43},"2026-05-08",{"date":277,"type":20},"2026-09-01",{"date":279,"type":20},"2029-08-31",{"name":281,"class":78},"Fred Hutchinson Cancer Center",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":21,"phases":291,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":302},"100467051","phase-2-genetic-testing-to-select-therapy-for-the-treatment-of-advanced-or-metastatic-kidney-cancer-optic-rcc-study-100467051","NCT05361720","Genetic Testing to Select Therapy for the Treatment of Advanced or Metastatic Kidney Cancer, OPTIC RCC Study","Optimal Treatment by Invoking Biologic Clusters in Renal Cell Carcinoma (OPTIC RCC)","Inclusion Criteria:\n\n* Histological confirmation of RCC with a clear cell component\n* Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer \\[AJCC\\] stage IV) RCC\n* Patient can comprehend and sign the study informed consent form\n* Male or female \\>= 18 years of age at the time of informed consent\n* Karnofsky performance status (KPS) of \\>= 70%\n* No prior systemic therapy for RCC in the neoadjuvant, adjuvant or metastatic setting\n* At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* Tumor tissue for ribonucleic acid (RNA)-sequencing (tumor tissue from bony metastasis is not suitable but a soft tissue component around bone is acceptable)\n\n  * Screening tissue consent- Patient must be assigned to either Cluster 1\u002F2 or 4\u002F5. Patients assigned to cluster 3\u002F6\u002F7 will not be eligible for the treatment study\n* Adequate renal function defined as calculated creatinine clearance \\>= 30 mL\u002Fmin per the Cockcroft and Gault formula\n* Adequate liver function defined by:\n\n  * Total bilirubin =\\\u003C 1.5 times the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 3 x ULN\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test during screening and prior to receiving first dose of protocol-indicated treatment\n\n  * Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal\n  * Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 years of age in the absence of other biological or physiological causes\n\nExclusion Criteria:\n\n* =\\\u003C 14 days before first dose of protocol-indicated treatment:\n\n  * Major surgery requiring general anesthesia\n* Inadequately controlled hypertension (systolic blood pressure \\[SBP\\] \\> 160\u002F90 mmHg)\n\n  * Anti-hypertensive medications are permitted.\n* Active infection requiring infusional treatment\n* Has preexisting gastrointestinal or non-gastrointestinal fistula\n* Proteinuria \\> 2 g\u002F 24 hours (hrs)\n\n  * If patient has 1+ protein on urine dipstick then a 24 hr urine collection is required\n* Non-healing wounds on any part of the body (for patients assigned to Cabo\u002FNivo only)\n* Known clinically significant active bleeding including hemoptysis\n* Inability to swallow oral medication; or the presence of a poorly controlled gastrointestinal disorder that could significantly affect the absorption of oral study drug (for patients assigned to Cabo\u002FNivo only) - e.g., Crohn's disease, ulcerative colitis, chronic diarrhea (defined as \\> 4 loose stools per day), malabsorption, or bowel obstruction\n* Significant cardiovascular disease or condition including:\n\n  * Class III or IV cardiovascular disease according to the New York Heart Association (NYHA) functional criteria\n  * Unstable angina pectoris (i.e., last episode =\\\u003C 3 months prior to first dose of protocol-indicated treatment)\n  * Myocardial infarction within 3 months prior to starting treatment\n* Subjects with central nervous system (CNS) metastases are eligible after they have completed local therapy (e.g., whole brain radiation therapy \\[WBRT\\], surgery or radiosurgery)\n* Any condition requiring systemic treatment with either systemic corticosteroids (\\> 10 mg\u002Fday prednisone or equivalent daily) or other immunosuppressive medications within 14 days prior to initiating protocol-indicated treatment\n* In the absence of active autoimmune disease: Subjects are permitted the use of corticosteroids with minimal systemic absorption (e.g., topical, ocular, intra-articular, intranasal, and inhalational), =\\\u003C 10 mg\u002Fday prednisone or equivalent daily; and physiologic replacement doses of systemic corticosteroids =\\\u003C 10 mg\u002Fday prednisone or equivalent daily (e.g., hormone replacement therapy needed in patients with hypophysitis)",{"count":290,"type":20},54,[63],"This phase II trial tests whether using genetic testing of tumor tissue to select the optimal treatment regimen works in treating patients with clear cell renal cell (kidney) cancer that has spread to other places in the body (advanced or metastatic). The current Food and Drug Administration (FDA)-approved regimens for advanced kidney cancer fall into two categories. One treatment combination includes two immunotherapy drugs (nivolumab plus ipilimumab), which are delivered by separate intravenous infusions into a vein. The other combination is one immunotherapy drug (nivolumab infusion) plus an oral pill taken by mouth (cabozantinib). Nivolumab and ipilimumab are \"immunotherapies\" which release the brakes of the immune system, thus allowing the patient's own immune system to better kill cancer cells. Cabozantinib is a \"targeted therapy\" specifically designed to block certain biological mechanisms needed for growth of cancer cells. In kidney cancer, cabozantinib blocks a tumor's blood supply. The genetic (DNA) makeup of the tumor may affect how well it responds to therapy. Testing the makeup (genes) of the tumor, may help match a treatment (from one of the above two treatment options) to the specific cancer and increase the chance that the disease will respond to treatment. The purpose of this study is to learn if genetic testing of tumor tissue may help doctors select the optimal treatment regimen to which advanced kidney cancer is more likely to respond.",[92,26,93,94],{"date":295,"type":43},"2026-04-27",{"date":297,"type":43},"2022-12-06",{"date":299,"type":20},"2027-07-01",{"name":301,"class":78},"Vanderbilt-Ingram Cancer Center",6,{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":313,"phases":4,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":343},"100542959","immune-checkpoint-inhibitor-response-in-solid-tumors-using-a-live-tumor-diagnostic-platform-100542959","NCT06349642","Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform","Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform","ELEPHAS-04","Inclusion Criteria:\n\nSubjects must meet one of the following criteria:\n\n* Subjects suspected of or diagnosed with the following Stage IV\u002Fmetastatic or recurrent malignancies:\n\n  * Lung: Non-small Cell Lung Cancer (NSCLC)\n  * Skin: Cutaneous Malignancy, excluding Uveal Melanoma\n  * Esophageal Cancer\n  * Cervical Cancer\n  * Endometrial Cancer\n  * Colon Cancer: Mismatch repair deficient (dMMR) CRC only\n  * All solid tumors with high tumor mutation burden (TMB)\n  * All solid tumors that are microsatellite instability high (MSI-H)\n  * All mismatch repair deficient (dMMR) solid tumors\n  * Liver Cancer\n  * Any solid tumor with measurable disease that is eligible for pure ICI therapy or that the clinician plans to treat with immune checkpoint inhibitor (ICI) therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate laboratory developed tests (LDTs) that, per clinician, render the patient eligible for ICI therapy, either frontline or a later line.\n\nOR\n\n* Subjects suspected of or diagnosed with the following Stage III per provider discretion or IV\u002Fmetastatic malignancies:\n\n  * Kidney: Clear Cell Renal Cell Carcinoma (ccRCC)\n  * Bladder: Urothelial Carcinoma (UC)\n  * Any solid tumor with measurable disease that is eligible for pure ICI therapy or that the clinician plans to treat with ICI therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate LDT tests that per clinician, render the patient eligible for ICI therapy, either frontline or a later line\n\nOR\n\n* Patients who will be receiving neoadjuvant CPI for the following resectable early-stage malignancies:\n\n  * Breast Cancer: Triple negative breast cancer (TNBC)\n  * Lung: Non-small cell lung cancer (NSCLC)\n\n    * NOTE: Patients with suspected NSCLC who would be eligible for neoadjuvant checkpoint inhibitor (CPI) are eligible to enroll per provider discretion\n  * Any solid tumor that is eligible for pure ICI therapy or that the clinician plans to treat with ICI therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate LDT tests that per clinician, render the patient eligible for ICI therapy, either frontline or a later line\n* LOCALLY ADVANCED\u002FMETASTATIC PATIENTS: Measurable disease as defined per protocol NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible.\n* NEOADJUVANT PATIENTS: Subjects must be eligible based on investigator discretion to receive approved CPI therapy.\n* Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy.\n* Subjects who are Stage I, II, or III and have progressed to metastatic cannot have received any anti-cancer treatment for at least 2 - 4 weeks (depending upon the washout period of prior anti-cancer treatment) prior to biopsy as per the agents used.\n* ECOG Performance Status (PS) 0, 1 or 2.\n* Negative pregnancy test done ≤7 days prior to enrollment, for persons of childbearing potential only\n* Female subjects must not be pregnant or breastfeeding and must use appropriate methods of contraception when applicable.\n* Subjects must be clinically able, at investigator discretion, and willing to undergo either:\n\n  * additional biopsy passes during their standard of care biopsy, OR\n  * a biopsy for research only, if applicable.\n  * NOTE: These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to biopsies per the clinician.\n* Subjects with a known secondary cancer diagnosis are eligible to participate if participation does not interfere with systemic anti-cancer standard of care treatment for suspected primary diagnosis.\n* Provide written informed consent\n\nExclusion Criteria:\n\n* Pregnant women because this study involves a greater than minimal risk procedure (biopsy)\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 for the biopsy\n* Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy\n\n  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * ongoing or active infection\n  * psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Subjects who are enrolled or plan to be enrolled in a blinded cancer therapeutic treatment trial",{"count":312,"type":20},324,"OBSERVATIONAL","This study is being done to collect tissue samples to test how accurately a tumor response platform, Elephas, can predict clinical response across multiple types of immunotherapies, chemoimmunotherapy and tumor types.",[316,317,241,26,242,318,319,320,246,321,247,322,323,324,325,93,256,94,326,327,328,329,330,331,332,333,334],"Early Stage Triple-Negative Breast Carcinoma","Metastatic Bladder Urothelial Carcinoma","Metastatic Endometrial Carcinoma","Metastatic Esophageal Carcinoma","Metastatic Liver Carcinoma","Metastatic Malignant Skin Neoplasm","Resectable Lung Non-Small Cell Carcinoma","Early Stage Lung Non-Small Cell Carcinoma","Resectable Malignant Solid Neoplasm","Resectable Triple-Negative Breast Carcinoma","Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Recurrent Cervical Carcinoma","Recurrent Colorectal Carcinoma","Recurrent Endometrial Carcinoma","Recurrent Esophageal Carcinoma","Recurrent Liver Carcinoma","Recurrent Lung Non-Small Cell Carcinoma","Recurrent Malignant Skin Neoplasm","Recurrent Malignant Solid Neoplasm","2026-03-11",{"date":337,"type":43},"2026-03-12",{"date":339,"type":43},"2024-04-24",{"date":341,"type":20},"2027-05",{"name":124,"class":78},3,{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":21,"phases":353,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":150},"100609754","phase-2-rp2-and-tivozanib-for-the-treatment-of-metastatic-renal-cell-cancer-after-progression-on-immunotherapy-100609754","NCT07218692","RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy","A Phase 2 Study of RP2 With Tivozanib in Patients With Metastatic Renal Carcinoma After Progression to Immunotherapy","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Must be willing to consent to provide fresh tumor biopsy sample or archival tumor biopsy sample obtained within 90 days before the first dose of study treatment\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Male or female who is 18 years of age or older at the time of signed informed consent\n* Eastern Cooperative Oncology Group (ECOG) 0 or 1\n* Histologically confirmed renal cell carcinoma with a clear-cell or sarcomatoid component\n* Patients must have received exactly one prior line or two prior lines of systemic therapy in the advanced or metastatic setting, including mandatory exposure to both an immune checkpoint inhibitor (ICI) and one antiangiogenic tyrosine kinase inhibitor (TKI). Prior treatment with hypoxia inducible factor (HIF)-α inhibitors is not permitted. Patients who received adjuvant immunotherapy and experienced disease recurrence within 6 months of completing treatment may also be eligible, and such therapy will count toward prior lines\n* Has injectable tumor(s), which alone or in aggregate, total at least 1 cm in diameter of RP2\n* Has at least 1 measurable tumor of ≥ 1 cm in longest diameter (or ≥ 1.5 cm shortest diameter for lymph nodes) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy\n* White blood cell (WBC) count ≥ 2.0 x 10\\^9\u002FL\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement\n* Platelets ≥ 100,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Hemoglobin ≥ 9g\u002FdL\n\n  * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease)\n* Aspartate aminotransferase (AST) ≤ 3.0 x ULN\n* Alanine aminotransferase (ALT) ≤ 3.0 x ULN\n* Creatinine clearance of ≥ 30 mL\u002Fmin per the Cockcroft-Gault formula or serum creatinine \\\u003C 1.5 x upper limit of normal (ULN)\n* If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN\n* If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n\n  * Note: To be performed within 28 days prior to day 1 of protocol therapy\n* QT interval corrected for heart rate using Bazetts's formula (QTcB) ≤ 480 ms\n\n  * Note: To be performed within 28 days prior to day 1 of protocol therapy\n* Women of childbearing potential (WOCBP) must have a negative serum beta-human chorionic gonadotropin (β-hCG) test with a minimum sensitivity of 25 IU\u002FL or equivalent units of β-hCG within 72 hours before the first dose and a negative urine pregnancy test on dose 1 day 1\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at and for at least (a) 90 days after the last dose of RP2 or for one month after the last dose of tivozanib. Men must also agree to refrain from donating sperm during the treatment period and for at least 90 days after the last dose of RP2\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Received a live vaccine within 28 days before the first dose of study treatment\n\n  * Note: Seasonal influenza vaccines for injection or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines are generally inactivated vaccines and are allowed. Live\u002Fattenuated vaccines (such as the intranasal influenza vaccines) are not allowed\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study treatment\n\n  * Note: Patients who have entered the follow-up phase of an investigational study may participate if it has been 4 weeks after the last dose of the previous investigational agent\n* Systemic anticancer therapies within 4 weeks of the first dose of study drug. The prior anti-PD-1 or anti-PD-L1 containing regimen is excluded from this requirement\n* Received prior treatment with an oncolytic virus therapy\n* Received radiotherapy within 2 weeks of start of study treatment. Patients must have recovered from all radiation-related toxicities (except for radiation-induced xerostomia), not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-central nervous system (CNS) disease\n\n  * Note: Patients must have recovered (to grade ≤ 1 or baseline) from all adverse events (AEs) due to previous therapies. Patients with grade ≤ 2 neuropathy may be eligible if approved by the medical monitor\n* Unstable cardiac disease as defined by one of the following:\n\n  * Cardiac events such as myocardial infarction (MI) within the past 6 months\n  * NYHA (New York Heart Association) heart failure class III-IV\n  * Uncontrolled atrial fibrillation or hypertension\n* History of allergy or sensitivity to study drug components or prior monoclonal antibody treatment; known hypersensitivity to Chinese hamster ovary cell products\n* Known human immunodeficiency virus (HIV) infection\n* Known acute or chronic hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known acute or chronic hepatitis C virus (defined as HCV ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected)\n\n  * Note 1: If HCV RNA testing not available, may use quantitative HCV RNA testing (preferred) or qualitative HCV antibody detection\n  * Note 2: For patients with known acute or chronic hepatitis B virus (HBV) and\u002For HCV infection, HBV and\u002For HCV viral load by real-time polymerase chain reaction (qPCR) must be below the limit of quantitation for the laboratory test used, and they must not have had recent treatment within 12 weeks for HBV or HCV with antiviral medications. Patients with acute or chronic HBV or HCV must be expected to not require antiviral therapy during the RP2 treatment period\n* Clinically significant uncontrolled illness\n* Active significant herpetic infections or prior complications of herpes simplex virus 1 (HSV-1) infection (eg, herpetic keratitis or encephalitis) or requires intermittent or chronic use of systemic (oral or intravenous \\[IV\\]) antivirals with known antiherpetic activity (eg, acyclovir)\n\n  * Note: Patients with sporadic cold sores may be enrolled if no active cold sores are present at the time of dose 1 day 1\n* Systemic infection requiring IV antibiotics or other serious infection within 14 days before dosing\n* Significant bleeding event within the last 12 months that places the patient at unjustifiable risk for bleeding from intratumoral injection procedures, based on Investigator or interventional radiologist assessment\n* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Known central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* History of interstitial lung disease, idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), non-infectious pneumonitis that required steroids, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan\n\n  * Note: History of radiation pneumonitis in the radiation field (fibrosis) is permitted\n* Active tuberculosis\n* History or evidence of psychiatric, substance abuse, or any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the investigator or the medical monitor, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion\n* Active, known, or suspected autoimmune disease requiring systemic treatment\n\n  * Note: Patients with type 1 diabetes mellitus and\u002For hypothyroidism requiring only hormone replacement, and\u002For with autoimmune skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, and\u002For prior non-serious autoimmune conditions not expected to recur are permitted to enroll\n* Conditions requiring treatment with immunosuppressive doses (\\> 10 mg per day of prednisone or equivalent) of systemic corticosteroids within 14 days before dose 1 day 1\n\n  * Note: Patients who require a brief course (≤ 7 days) of corticosteroids (eg, as prophylaxis for imaging studies due to hypersensitivity to contrast agents) are not excluded. Physiologic replacement doses of systemic corticosteroids are permitted, only if the dose does not exceed 10 mg\u002Fday prednisone equivalent\n* History of life-threatening toxicity related to prior immune therapy (eg, anti-cytotoxic T lymphocyte antigen 4 or anti-PD-1\u002Fanti-PD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways \\[eg, CD40,4-1BB\\]) except those that are unlikely to recur or are expected to be manageable with standard countermeasures (eg, hormone replacement after adrenal crisis). Individual cases should be discussed with medical monitor if needed\n* Conditions in which anticoagulant therapies cannot be safely stopped in the periprocedural period or patients on coumadin with a target INR \\> 2.5 or that cannot be temporarily reversed to INR ≤ 1.7\n* Treatment with botanical preparations (eg, herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks before treatment\n* Prior organ transplantation including allogeneic stem-cell transplantation\n* Major surgery within 28 days before starting treatment or anticipated major surgery while on study\n\n  * Note: If a patient received major surgery, they must have recovered adequately from the intervention before starting study treatment and must have adequate wound healing, based on investigator's assessment or surgeon's assessment, before starting tivozanib\n* Females only: Pregnant or breastfeeding\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":352,"type":20},35,[63],"This phase II trial tests the effect of RP2 and tivozanib in treating patients with renal cell cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that is growing, spreading, or getting worse (progressive) after receiving immunotherapy with immune checkpoint inhibitors (ICIs). RP2 is a herpes simplex virus (a viral infection commonly known as the \"cold sore virus\") that has been changed to infect and destroy tumor cells and to activate (turn on) the human immune system to attack the tumor cells. Tivozanib hydrochloride blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Tivozanib hydrochloride is a type of tyrosine kinase inhibitor and a type of antiangiogenesis agent. Giving RP2 and tivozanib may be safe, tolerable, and\u002For effective in treating patients with metastatic renal cell cancer that has progressed after receiving immunotherapy with ICIs.",[92,356,191,26,357,192,358,93,94],"Advanced Renal Cell Carcinoma","Metastatic Renal Cell Carcinoma","Recurrent Renal Cell Carcinoma","2025-10-16",{"date":361,"type":43},"2025-10-20",{"date":363,"type":20},"2026-08-11",{"date":365,"type":20},"2027-08-11",{"name":201,"class":78},{"id":368,"slug":369,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":21,"phases":376,"briefSummary":377,"conditions":378,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":51},"100606762","phase-1-effects-of-belzutifan-on-89zr-dfo-girentuximab-pet-uptake-in-patients-with-renal-cell-carcinoma-rcc-100606762","NCT07179770","Effects of Belzutifan on 89Zr-DFO-girentuximab PET Uptake in Patients With Renal Cell Carcinoma (RCC)","A Phase 1b Study to Assess the Effects of Belzutifan on 89Zr-DFO-girentuximab Uptake as a Surrogate to Determine CAIX Tumor Expression in Patients With Clear Cell Renal Cell Carcinoma","Inclusion Criteria:\n\n1. Histologically confirmed advanced clear cell RCC\n2. Radiographic disease progression to prior immune checkpoint inhibitor (ICI) therapy for RCC\n\n   * ICI for adjuvant therapy: Patients who experienced radiographic tumor progression during or within 6 months after last dose of adjuvant ICI\n   * ICI for locally advanced or metastatic disease: radiographic disease progression during or following ICI treatment in the 1st line setting\n   * Minimum two previous treatment regimens but no maximum limit\n3. Measurable disease per RECIST v1.1\n4. Recovery to baseline or Grade1 NCI CTCAE v5.0 from toxicities related to any prior treatments, unless adverse events are clinically nonsignificant and\u002For stable in the opinion of the investigator.\n5. Age\\>18 years of age\n6. Karnofsky performance score ≥60%\n7. Patients must have adequate organ and marrow function as defined below:\n\n   * absolute neutrophil count ≥1,000\u002FmcL\n   * platelets ≥100,000\u002FmcL\n   * total bilirubin ≤ institutional upper limit of normal (ULN)\n   * Aspartate Aminotransferase (AST) (SGOT)\u002FAlanine Aminotransferase (ALT) (SGPT ≤3 × institutional ULN\n   * creatinine ≤ institutional ULN OR\n   * glomerular filtration rate (GFR) ≥60 mL\u002Fmin\u002F1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73 m2\n\n     1. Patients with abnormal test results outside the allowable range, but are not clinically significant, may still enroll with PI's review and approval.\n     2. Laboratory reference values should account for potential normal variations due to race, ethnicity, age, sex, and gender identity (e.g., due to surgical and\u002For hormonal changes).\n8. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n9. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n10. 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.\n11. Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n12. 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.\n13. 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.\n14. 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.\n15. Patients who agree to use an adequate method of contraception throughout the study period, starting with the administration of 89Zr-DFO-girentuximab,\n16. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. 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.\n2. Patients who are receiving any other investigational agents.\n3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to girentuximab.\n4. Patients with uncontrolled intercurrent illness at the discretion of the investigator.\n5. Pregnant women are excluded from this study because belzutifan is an agent with the potential for teratogenic or abortifacient effects.",{"count":375,"type":20},12,[188],"The purpose of this study is to identify changes in Carbonic Anhydrase IX (CAIX) expression induced by hypoxia-inducible factor 2 alpha (HIF-2α) inhibition by initiating belzutifan single agent therapy and imaging CAIX expression with 89Zr-DFO-girentuximab PET before and 4 weeks after initiating treatment. This will be the first study to evaluate potential changes in CAIX expression altered by belzutifan. Information gained from this study will be leveraged to develop combinations of belzutifan with CAIX targeted agents including radioimmunotherapy in the future.",[26],"2025-09-22",{"date":381,"type":43},"2025-09-23",{"date":383,"type":43},"2025-09-15",{"date":385,"type":20},"2027-10-01",{"name":387,"class":78},"NYU Langone Health",{"id":389,"slug":390,"hasResults":11,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":21,"phases":397,"briefSummary":398,"conditions":399,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":51},"100582665","phase-1-inulin-gel-in-combination-with-ipilimumab-and-nivolumab-for-the-treatment-of-metastatic-or-locally-advanced-kidney-cell-cancer-icon-trial-100582665","NCT06866262","Inulin Gel in Combination With Ipilimumab and Nivolumab for the Treatment of Metastatic or Locally Advanced Kidney Cell Cancer, ICON Trial","Phase I\u002FII Trial of Inulin Gel in Combination With Ipilimumab and Nivolumab in Advanced Renal Cell Carcinoma [ICON Trial]","Inclusion Criteria:\n\n* Patient is ≥ 18 years of age on the day of signing informed consent.\n* Candidate for ipilimumab and nivolumab therapy for metastatic renal cancer per the treating physician investigator.\n* Patient has a performance status of ≤ 2 on the Zubrod performance scale.\n* Patient has a histological or cytological diagnosis of renal cancer with clear cell or sarcomatoid component.\n* Radiologic or clinical evidence of metastatic disease, or progressive locally advanced disease.\n* Absolute neutrophil count ≥ 1,500\u002FuL.\n* Platelets ≥ 75K\u002FμL.\n* Hemoglobin ≥ 8.5 g\u002FdL.\n* Calculated creatinine clearance is ≥ 30 ml\u002Fmin as per the Cockroft-Gault formula.\n* Direct bilirubin ≤ 1.5 x upper limit of normal (ULN) OR total bilirubin levels ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels \\> 1.5 ULN.\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 3 x ULN except for patients with liver metastases, AST\u002FALT should be ≤ 5 x ULN.\n* Patient received no prior systemic anti-cancer therapy for metastatic disease.\n* Patient has evaluable or measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Bone metastases, pleural effusion or ascites will be considered evaluable disease sites.\n\n  * Tumor mass: Must be accurately measurable in at least 1 dimension (longest diameter to be recorded) with a minimum size of:\n\n    * 10 mm by CT scan (CT scan slice thickness no greater than 5 mm,\n\nOr:\n\n* 20 mm by chest X-ray (if clearly defined and surrounded by aerated lung). With or without malignant lymph nodes: ≥ 15 mm in short axis when assessed by CT scan (CT scan slice thickness must be ≤ 5 mm). The measurement should be two dimensions at axial plane. The short axis should be in perpendicular to long diameter.\n\n  * Ability to understand and the willingness to review and sign a written informed consent.\n  * Both male and female patients must agree to use adequate contraceptive measures to prevent pregnancy throughout the duration of study therapy and a minimum of -5 months after stopping therapy per package insert of ipilimumab and nivolumab.\n  * Ability to ingest oral therapy.\n  * Female patient of childbearing capacity has a negative pregnancy test within 7 days of starting study therapy.\n\nExclusion Criteria:\n\n* The subject has received cytotoxic therapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) or immunosuppressants (excluding steroids) within 4 weeks or antibiotics within 2 weeks of starting study therapy.\n* Patient is currently enrolled in another clinical trial testing another investigational agent, or concurrently in another approved systemic anti-cancer therapy for renal cancer.\n* Patient is on chronic systemic steroid therapy at doses \\> 10 mg\u002Fday prednisone equivalent or on any other immunosuppressive therapy within 7 days prior to day 1 of therapy. Exception-Replacement steroid doses for adrenal insufficiency are permitted as necessary.\n* Subjects with active and uncontrolled autoimmune disease. Subjects with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll.\n* Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease must not require immediate CNS specific treatment at the time of study registration. Patients who have completed CNS therapy prior to starting therapy and clinically stabilized are also eligible.\n* Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or make study participation not in the best interest of the patient, in the opinion of the treating investigator.\n* Patient has known psychiatric or substance abuse disorders that, in the opinion of the investigator, would interfere with cooperation with the requirements of the trial.\n* Pregnant patients or patients planning donation of sperm or breast milk during the therapy and for a minimum of 5 months after stopping therapy.\n* Lactating patients if they do not agree to discontinue breast feeding through the entire duration of study participation and for 5 months after stopping therapy.\n* History of another metastatic\u002Frelapsed active malignancy. Localized skin cancers such as basal cell or squamous cell cancer are allowed.\n* Intractable nausea and vomiting refractory to therapy with antiemetics.\n* History of hypersensitivity to ipilimumab, nivolumab, inulin or the formulations excipients.\n* Known diagnosis of malabsorption disorder.\n* Concurrent use of probiotics or antibiotics.\n* Patients with a history of colectomy and\u002For gastric bypass.\n* Patients with a known diagnosis of active inflammatory bowel disease or irritable bowel syndrome.\n* History of organ transplant or stem cell\u002Fbone marrow transplant.\n* Patients with active Clostridium difficile infection within 3 months before therapy start. Active infection is defined as a stool sample positive for Clostridium difficile toxin by enzyme immunoassay (EIA) and either symptoms (frequent loose stools) OR imaging findings consistent with toxic megacolon.",{"count":396,"type":20},55,[188,63],"This phase I\u002FII trial tests the safety and effectiveness of inulin gel in combination with ipilimumab and nivolumab in treating patients with kidney cell cancer (renal cell carcinoma \\[RCC\\]) that has spread from where it first started (primary site) to other places in the body (metastatic) or has spread to nearby tissue or lymph nodes (locally advanced). Inulin is a common food additive fermentable prebiotic fiber beneficial for a healthy gut microbiome. The microbiome is the collection of all microbes, such as bacteria, fungi, viruses, and their genes, that naturally live on and inside the body. Inulin may also be used for cancer prevention and heart health, but there is less evidence to support those uses. The gut microbiome profile may improve the effectiveness of drugs called immune checkpoint inhibitors, such as ipilimumab and nivolumab. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving inulin gel in combination with ipilimumab and nivolumab may be safe and effective in treating in patients with metastatic or locally advanced RCC.",[400,401,26,192,93,94],"Locally Advanced Clear Cell Renal Cell Carcinoma","Locally Advanced Sarcomatoid Renal Cell Carcinoma",{"date":403,"type":43},"2025-09-09",{"date":405,"type":43},"2025-08-15",{"date":407,"type":20},"2031-08-01",{"name":409,"class":78},"University of Michigan Rogel Cancer Center",{"id":411,"slug":412,"hasResults":11,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":416,"eligibilityCriteria":417,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":21,"phases":420,"briefSummary":421,"conditions":422,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":430},"100401695","phase-3-comparing-the-outcome-of-immunotherapy-based-drug-combination-therapy-with-or-without-surgery-to-remove-the-kidney-in-metastatic-kidney-cancer-the-probe-trial-100401695","NCT04510597","Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial","Phase III Trial of Immunotherapy-Based Combination Therapy With or Without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma (PROBE Trial)","PROBE","Inclusion Criteria:\n\n* STEP 1 REGISTRATION: Participants must have a histologically proven diagnosis of clear cell or non-clear cell renal cell carcinoma. Participants with collecting duct carcinoma histology are not eligible. Participants with multifocal or bilateral tumors are eligible\n* STEP 1 REGISTRATION: Participants must have primary tumor in place\n* STEP 1 REGISTRATION: Participants must have the following scans performed, showing clinical evidence of measurable or non-measurable metastatic disease:\n\n  * Computed tomography (CT) scan of the chest (can be performed without contrast if CT contrast cannot be given)\n  * CT of abdomen and pelvis with contrast OR magnetic resonance imaging (MRI) of the abdomen and pelvis with or without contrast\n\nScans must be performed within the following timeframes:\n\n* Treatment naive participants must have scans documenting metastatic disease completed within 90 days prior to study registration\n* Previously treated participants must have scans documenting metastatic disease completed within 90 days prior to first dose of systemic treatment\n\n  * STEP 1 REGISTRATION: Participants with symptomatic metastases may have received palliative radiotherapy or receive palliative radiotherapy after registration\n  * STEP 1 REGISTRATION: Participants must have no clear contraindications to nephrectomy\n  * STEP 1 REGISTRATION: Participants must be offered the opportunity to participate in specimen bank. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System\n  * STEP 1 REGISTRATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n  * STEP 1 REGISTRATION: As part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n  * STEP 2 REGISTRATION: Participants must have at least one of the following scans performed 12 weeks (+\u002F- 2 weeks) after starting pre-randomization treatment\n* CT scan of the chest (can be performed without contrast if CT contrast cannot be given)\n* CT of abdomen and pelvis with contrast OR MRI of the abdomen and pelvis with or without contrast Scans must be performed within 28 days prior to randomization. Response should be assessed by comparing with a CT or MRI of the chest, abdomen and pelvis obtained prior to starting pre-randomization treatment. Participants with complete response in all metastatic sites are not eligible to randomize to Step 2\n\n  • STEP 2 REGISTRATION: Participants must have one of the following objective statuses after 12 weeks of pre-randomization treatment\n* Stable disease\n* Partial response\n* The treating investigator believes the patient is deriving clinical benefit from systemic therapy AND have Zubrod performance status 0-1\n\n  * STEP 2 REGISTRATION: Participants must plan to continue the immune-based therapy received during pre-randomization treatment\n  * STEP 2 REGISTRATION: Participants must be randomized on or between the 11th and 14th week of protocol-directed pre-randomization treatment therapy\n  * STEP 2 REGISTRATION: Participants must have received at least one of the minimum amounts of immunotherapy:\n* 2 infusions of nivolumab + 1 infusion of ipilimumab\n* 2 infusions of pembrolizumab\n* 2 infusions of avelumab\n\n  * STEP 2 REGISTRATION: Participants must have a planned surgery date within 42 days of randomization\n  * STEP 2 REGISTRATION: Participants must be a surgical candidate as determined by study urologist. The urology consult should be done within 42 days prior to randomization\n  * STEP 2 REGISTRATION: Participants must have a complete physical examination and medical history within 28 days prior to randomization\n  * STEP 2 REGISTRATION: Participants must have a Zubrod performance status of 0-1 within 28 days prior to randomization\n  * STEP 2 REGISTRATION: Total bilirubin =\\\u003C institutional upper limit of normal (ULN) (within 28 days prior to randomization)\n  * STEP 2 REGISTRATION: Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 3 x institutional upper limit of normal (ULN) (within 28 days prior to randomization)\n  * STEP 2 REGISTRATION: Serum creatinine =\\\u003C 1.5 x the institutional upper limit of normal (IULN) OR measured OR calculated creatinine clearance \\>= 50 mL\u002Fmin using the Cockcroft-Gault Formula) (must have been drawn and processed within 28 days prior to randomization)\n\nExclusion Criteria:\n\n* STEP 1 REGISTRATION: Participants must not have known active brain metastases. Participants with previously treated brain metastases are eligible if participant has no neurologic signs or symptoms suggestive of brain metastasis. Brain imaging studies are not required. If brain imaging studies are performed, they must be negative for disease\n* STEP 1 REGISTRATION: Participants must not have received the following prior treatment of metastatic renal cell carcinoma:\n\n  * Treatment naive participants must not have received any prior lines of systemic therapy for metastatic renal cell carcinoma beyond the line intended as part of protocol therapy\n  * Previously treated participants must not have received any systemic therapy for metastatic renal cell carcinoma beyond the one regimen received off protocol as specified in Step 1 pre-randomization treatment\n* STEP 1 REGISTRATION: Participants must not have received more than the following amounts protocol-directed pre-randomization treatment:\n\n  * Treatment naive participants must not have received any pre-randomization treatment.\n  * Previously treated participants must not be planning to receive any additional treatment prior to Step 2 randomization, and must not have received more than the following amounts of pre-randomization treatment:\n\n    * 4 infusions of nivolumab\n    * 4 infusions of ipilimumab\n    * 4 infusions of pembrolizumab\n    * 7 infusions of avelumab\n* STEP 1 REGISTRATION: Participants must not have received immunotherapy for any cancer within the following timeframes:\n\n  * Treatment naive participants must not have received any immunotherapy within a year of registration\n  * Previously treated participants must not have received any other immunotherapy within a year of the start of off protocol specified pre-randomization treatment\n* STEP 1 REGISTRATION: Participants must not have a solitary kidney and not have a transplanted kidney\n* STEP 1 REGISTRATION: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, any in situ or T1 cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for at least two years\n* STEP 1 REGISTRATION: Participants must not have been previously diagnosed with a medical condition that makes them ineligible for immune based combination therapy or nephrectomy\n* STEP 2 REGISTRATION: Participants must not show progression in the primary tumor. Participants who are considered to have pseudo progression are allowed\n* STEP 2 REGISTRATION: Participants must not have known active brain metastases. Participants with previously treated brain metastases are eligible if participant has no neurologic signs or symptoms suggestive of brain metastasis. Brain imaging studies are not required. If brain imaging studies are performed, they must be negative for disease\n* STEP 2 REGISTRATION: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years",{"count":419,"type":20},364,[89],"This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer.",[26,357,94],"2025-09-02",{"date":403,"type":43},{"date":426,"type":43},"2021-03-08",{"date":428,"type":20},"2033-07",{"name":103,"class":104},387,{"id":432,"slug":433,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":21,"phases":439,"briefSummary":440,"conditions":441,"keywords":447,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":51},"100588492","phase-1-imaging-of-solid-tumors-using-18f-trx-100588492","NCT06942104","Imaging of Solid Tumors Using 18F-TRX","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Advanced solid tumor malignancy in one of the following cohorts:\n\n  * Cohort 1 (n = 6): Any solid tumor malignancy with at least 3 metastatic lesions on conventional imaging\n  * Cohort 2 (n = 50):\n\n    * WHO grade 3 or 4 glioma - patients with known (by integrated molecular and histopathologic diagnosis) or presumed (by imaging; e.g., enhancing necrotic and\u002For hypervascular intrinsic brain tumor) high grade (WHO grade 3 or 4) glioma (n = 10), Locally advanced or metastatic clear cell renal cell carcinoma with at least three metastatic lesions on conventional imaging (n = 10).\n    * Metastatic castration-resistant prostate cancer with at least one metastatic lesion on conventional imaging including cross-sectional imaging of the chest, abdomen and pelvis and whole body bone scan or prostate-specific membrane antigen (PSMA) PET scan (n = 30).\n* Ability to understand and the willingness to sign a written informed consent document.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Negative serum or urine pregnancy test (women of childbearing potential only) within 72 hours of baseline procedures.\n* Absolute neutrophil count \\> 1.5 x 10\\^6\u002FL.\n* Platelets \\> 75,000 x 10\\^6\u002FL.\n* Hemoglobin \\> 8 g\u002FdL.\n* Total bilirubin \\\u003C 1.5 x upper limit of normal.\n* Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase (SGOT)) \\\u003C 2.5 x upper limit of normal (\\\u003C 5 x upper limit of normal in patients with liver metastases on conventional imaging).\n* Alanine aminotransferase (ALT)(serum glutamic-pyruvic transaminase (SGPT)) \\\u003C 2.5 x upper limit of normal (\\\u003C 5 x upper limit of normal in patients with liver metastases on conventional imaging).\n* Creatinine clearance \\> 50 ml\u002Fmin, calculated using the Cockcroft-Gault equation.\n\nExclusion Criteria:\n\n* Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures.\n* Individuals receiving strong inhibitors or inducers of CYP3A4.\n* Uncontrolled active infection or other medical condition that would preclude safe participation in the study as judged by the Investigator.\n* Individuals who are pregnant.\n\n  * Individuals of childbearing potential (defined below) must agree to undergo a urine pregnancy test prior to participating in the study scans. Pregnant individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn child secondary to administration of 18F-TRX to the study participant.\n  * A female is considered to not be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if the participant meets either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries).\n* Individuals who are breastfeeding\u002Fchestfeeding.\n\n  * Breastfeeding\u002Fchestfeeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn\u002Fnursing child secondary to administration of 18F-TRX to the study participant.\n  * Breastfeeding\u002Fchestfeeding should be discontinued before administration of 18F-TRX.",{"count":438,"type":20},56,[188],"This phase I trial tests the safety and effectiveness of 18F-TRX in detecting tumors (cancer) patients with solid tumors. 18F-TRX is an imaging tracer that is used to visualize tumors using a PET scan. It specifically targets and detects labile (unstable) iron levels within tissues, including tumors. Diagnostic procedures, such as 18F-TRX PET\u002FCT or PET\u002FMRI, may help detect tumors in patients with solid tumors",[442,443,444,400,26,247,93,94,445,446],"Solid Tumor","Solid Carcinoma","Castration-Resistant Prostate Carcinoma","Stage IVB Prostate Cancer AJCC v8","Glioma, Malignant",[448],"Imaging Studies","2025-07-17",{"date":451,"type":43},"2025-07-18",{"date":453,"type":43},"2025-07-03",{"date":455,"type":20},"2026-09-30",{"name":457,"class":78},"Rahul Aggarwal",{"id":459,"slug":460,"hasResults":11,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":21,"phases":467,"briefSummary":468,"conditions":469,"keywords":470,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":51},"100549030","early-phase-1-18f-psma-1007-petct-in-metastatic-clear-cell-renal-cell-carcinoma-100549030","NCT06428708","[18F] PSMA-1007 PET\u002FCT in Metastatic Clear Cell Renal Cell Carcinoma","Comparison of [18F] PSMA-1007 PET\u002FCT and Conventional Imaging in the Detection of Metastatic Clear Cell Renal Cell Carcinoma","Inclusion Criteria:\n\n1. Men and women with histologically-proven, metastatic renal cell carcinoma (RCC)(TNM stage Tany, Nany, M1)\n2. Must have baseline conventional imaging of the chest, abdomen, and pelvis with contrast-enhanced CT or MRI within 5 weeks of enrolment. Contrast is required unless the participant cannot for medical reasons (ie renal failure).\n\nException: Unenhanced CT of the chest is acceptable Exception: Unenhanced MRI of abdomen and pelvis is acceptable in cases of renal failure\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding\n2. Age less than 18\n3. Histology does not have any clear cell component\n4. Unable to lie flat for 30 minutes for the scan\n5. History of prior malignancy (except non-melanoma skin cancer)\n6. Unable to provide informed consent\n7. Inadequate liver function\n8. Systemic or radiation-based cancer treatment is needed urgently and anticipated to begin before PSMA scan can take place\n9. Previously exposed to systemic or radiation cancer therapy (except radiation for skin cancer)",{"count":466,"type":20},30,[23],"Staging of kidney cancer is primarily achieved by computerized tomography (CT) scans or magnetic resonance imaging (MRI). If a patient is found to have limited metastatic disease, surgical removal or radiation therapy could be considered in order to control the majority of the disease. However, if metastases are more widespread, systemic (drug) therapy may be the preferred management option. The identification of additional metastatic sites using more sensitive imaging modalities therefore has the potential to alter management, and this remains an unmet need in the field. This study will investigate the utility of positron emission tomography (PET) imaging with PSMA (prostate specific membrane antigen). Kidney cancer of the clear cell subtype has demonstrated high expression of PSMA, making it a disease in which PSMA-targeted PET imaging could help to identify occult metastatic disease.",[26],[471,472,473,474],"PSMA PET","Metastatic clear cell renal cell carcinoma","[18F]PSMA-1007","PSMA","2024-06-22",{"date":477,"type":43},"2024-06-25",{"date":479,"type":43},"2022-01-24",{"date":481,"type":20},"2025-09",{"name":483,"class":78},"Western University",{"id":485,"slug":486,"hasResults":11,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":21,"phases":493,"briefSummary":494,"conditions":495,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":51},"100546781","phase-1-cbm588-capsules-in-combination-with-nivolumab-and-ipilimumab-for-the-treatment-of-advanced-stage-kidney-cancer-100546781","NCT06399419","CBM588 Capsules in Combination With Nivolumab and Ipilimumab for the Treatment of Advanced Stage Kidney Cancer","An Open-Label, Phase I, Dose-Finding Study of CBM588 in Combination With Nivolumab\u002FIpilimumab for Patients With Advanced Stage Renal Cell Carcinoma","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principle investigator (PI) approval\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Age ≥ 18 years\n* Histologically confirmed renal cell carcinoma with clear cell renal cell carcinoma component or sarcomatoid component\n* Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer \\[AJCC\\] stage IV) renal cell carcinoma with intermediate- or poor-risk disease by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria\n* No prior systemic therapy for renal cell carcinoma (RCC) with the following exception:\n\n  * One prior adjuvant or neoadjuvant therapy for completely resectable RCC if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy\n* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy\n* Absolute neutrophil count (ANC) ≥ 1500\u002FuL without granulocyte colony-stimulating factor support\n* White blood cell count ≥ 2500\u002FuL\n* Platelets ≥ 100,000\u002FuL without transfusion\n* Hemoglobin ≥ 8 g\u002FdL\n* Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 x upper limit of normal (ULN). ALP ≤ 5 x ULN with documented bone metastases\n* Total bilirubin ≤ 1.5 x ULN (for subjects with Gilbert's disease ≤ 3 x ULN)\n* Serum albumin ≥ 2.8 g\u002Fdl\n* Prothrombin time (PT)\u002Finternational normalized ratio (INR) or partial thromboplastin time (PTT) test \\\u003C 1.3 x the laboratory ULN\n* Serum calculated creatinine clearance ≥ 50mL\u002Fmin using the Cockcroft-Gault equation\n* Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 5 months after the last dose of nivolumab for women with childbearing potential, and 7 months after the last dose of nivolumab for men\n* Female subjects of childbearing potential must not be pregnant at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes. In addition, females \\\u003C 55 years-of-age must have a serum follicle stimulating (FSH) level \\> 40 mIU\u002FmL to confirm menopause).\n\n  * Note: Documentation may include review of medical records, medical examinations, or medical history interview by study site\n\nExclusion Criteria:\n\n* Prior treatment with ipilimumab and\u002For nivolumab\n* Current use, or intent to use, probiotics, yogurt, or bacterial fortified foods during the period of treatment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Active interstitial lung disease (ILD)\u002Fpneumonitis or history of ILD\u002Fpneumonitis requiring treatment with systemic steroids\n* Known medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results\n* Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment\n* Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis). Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment\n* Administration of a live, attenuated vaccine within 30 days before first dose of study treatment\n* The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  * Any condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days before first dose of study treatment. Note: Inhaled, intranasal, intra-articular, or topical steroids are permitted. Adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent are permitted. Transient short-term use of systemic corticosteroids for allergic conditions (e.g., contrast allergy) is also allowed\n  * Active infection requiring systemic treatment. Acute or chronic hepatitis B or C infection, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness requiring systemic treatments, or known positive test for tuberculosis infection where there is clinical or radiographic evidence of active mycobacterial infection\n  * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan\n  * Malabsorption syndrome\n  * Uncompensated\u002Fsymptomatic hypothyroidism\n  * Moderate to severe hepatic impairment (Child-Pugh B or C)\n  * Requirement for hemodialysis or peritoneal dialysis\n  * History of solid organ or allogenic stem cell transplant\n  * Other clinically significant disorders that would preclude safe study participation\n\n    * Any active, known, or suspected autoimmune disease will be excluded, with the following exceptions:\n\n      * Type 1 diabetes mellitus\n      * Hypothyroidism only requiring hormone replacement\n      * Skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment\n      * Conditions not expected to recur in the absence of an external trigger\n* Pregnant or lactating females\n* Inability to swallow tablets\u002Fcapsules or unwillingness or inability to receive IV administration\n* Previously identified allergy or hypersensitivity to components of the study treatment formulations or history of severe infusion-related reactions to monoclonal antibodies. Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption are also excluded\n* Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast\n* Exclusion of subjects with a history of myocarditis or congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), as well as unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction 6 months prior to study entry\n* Exclusion of subjects whose baseline pulse oximetry is less than 92% on room air\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":492,"type":20},28,[188],"This phase I trial tests the safety, side effects, best dose, and effectiveness of CBM588 in combination with nivolumab and ipilimumab in treating patients with kidney cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). CBM588 is a live biotherapeutic that may help improve the effects of immunotherapy. Nivolumab and ipilimumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread by enhancing the ability of the body's immune cells to attack tumor cells. CBM588 in combination with nivolumab and ipilimumab may be safe, tolerable, and\u002For effective in treating patients with advanced stage kidney cancer.",[92,356,191,26,357,192,93,94],"2024-05-28",{"date":498,"type":43},"2024-05-30",{"date":500,"type":20},"2024-06-19",{"date":502,"type":20},"2026-10-19",{"name":504,"class":50},"Osel, Inc."]