[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-renal-cell-carcinoma--mrcc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-renal-cell-carcinoma--mrcc":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,82,112],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100607464","phase-2-a-randomized-trial-of-fianlimab-and-cemiplimab---ipilimumab-or-ipilimumab-plus-nivolumab-in-first-line-advanced-renal-cell-carcinoma-rcc-100607464",false,"NCT07188896","A Randomized Trial of Fianlimab and Cemiplimab +\u002F- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)","A Randomized Phase 2 Trial of Fianlimab and Cemiplimab +\u002F- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)","Inclusion Criteria:\n\n1. Signed informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent.\n3. Karnofsky Performance Status ≥ 70% within 14 days prior to registration.\n4. Histological or cytological evidence of renal cell carcinoma having a clear cell component\n5. Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV \\[version 9\\]) renal cell carcinoma.\n6. Treatment naïve for systemic therapy for renal cell carcinoma including no prior neo\u002Fadjuvant systemic therapy\n7. Measurable disease according to RECIST 1.1 within 28 days prior to registration.\n8. Patient must have either a formalin-fixed, paraffin-embedded (FFPE) tissue block or unstained tumor tissue sections, obtained from preferably a metastatic lesion, preferably within 3 months or no more than 12 months with an associated pathology report. If the metastatic lesion biopsy specimen does not contain at least 20 unstained slides, supplementation with primary kidney cancer tissue is acceptable.\n9. Demonstrate adequate organ function as defined in the protocol. All screening labs to be obtained within 14 days prior to registration.\n10. Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration.\n11. Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from penile-vaginal intercourse or must use an effective method(s) of contraception. Males able to father a child who are sexually active with a female of childbearing potential must be willing to abstain from penile-vaginal intercourse or use an effective method(s) of contraception.\n12. Known HIV-infected subjects on effective anti-retroviral therapy with undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen within 6 months of registration are eligible for this trial. Testing is not required at screening unless mandated by local policy\n13. Subjects with known chronic hepatitis B virus (HBV) infection, must have an undetectable HBV viral load (serum hepatitis B virus DNA PCR that is below the limit of detection) and be on suppressive therapy, if indicated.\n14. Subjects with a history of hepatitis C virus (HCV) infection must have been treated and cured (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy). For subjects with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial. Testing is not required at screening unless mandated by local policy.\n15. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n\nExclusion Criteria:\n\n1. Prior systemic therapy against renal cell carcinoma in the neo\u002Fadjuvant or metastatic setting\n2. Any condition requiring ongoing ≥ 10 mg prednisone equivalent\u002Fday\n3. Participants with a history of myocarditis.\n4. If clinically indicated based on clinical assessment and any ECG abnormalities, optional troponin T (TnT) or troponin I (TnI) may be done as described in the protocol.\n5. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are allowed: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.\n6. Central nervous system (CNS) metastases as described in the protocol.\n7. Active infection requiring systemic therapy as described in the protocol.\n8. Pregnant or breastfeeding as described in the protocol.\n9. Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per treating physician discretion.\n10. Subjects must not receive live attenuated vaccines within 4 weeks prior to Cycle 1 Day 1 or at any time during the study. Inactivated vaccines are allowed.\n11. Known hypersensitivity to the active substances or to any of the excipients.\n12. Currently participating in another study or participated in any study of an investigational agent or investigational device within 30 days of the first dose of study drug.","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This three-arm randomized phase 2 trial will enroll advanced clear cell RCC patients (all IMDC risk groups). Patients will be randomized 2:2:1 to either Arm A (fianlimab\u002F cemiplimab\u002F ipilimumab), Arm B (fianlimab\u002F cemiplimab), or Arm C (standard ipilimumab\u002F nivolumab), respectively.",[26,27,28],"Advanced Renal Cell Carcinoma (aRCC)","Metastatic Renal Cell Carcinoma ( mRCC)","Clear Cell Renal Cell Carcinoma (ccRCC)","RECRUITING","2026-07-01",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2026-04-29",{"date":37,"type":20},"2030-11-30",{"name":39,"class":40},"Brian Rini","OTHER",2,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":67,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100610425","phase-1-symbiotic-gu-08-a-study-to-learn-about-the-medicine-called-pf-08634404-dosed-alone-and-in-combination-with-other-anticancer-therapies-in-adults-with-locally-advanced-or-metastatic-renal-cell-cancer-100610425","NCT07227415","Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer","AN INTERVENTIONAL PHASE 1B\u002F2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY AND IN COMBINATION WITH OTHER ANTICANCER AGENTS IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA","Inclusion Criteria:\n\n* 18 years of age or older at screening\n* Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC with diagnosis confirmed by histology\u002Fcytology\n* At least one measurable (as defined by the investigator) and untreated lesion\n* Adequate hematologic, hepatic, cardiac and renal function\n* No prior systemic therapy for RCC (immunotherapy after surgery is allowed if received \\>12 months prior)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* All International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) based risk categories\n\nExclusion Criteria:\n\nParticipants may be excluded if they meet any of the following:\n\n* Known active brain lesions including leptomeningeal metastasis, brainstem, meningeal or spinal cord metastases or compression.\n* Clinically significant risk of haemorrhage or fistula\n* History of another malignancy within 3 years\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* active autoimmune diseases requiring systemic treatment within the past 2 years\n* uncontrolled cardiac and other comorbidities within 6 months prior to the first dose\n* Major surgery or severe trauma within 4 weeks before the first dose, or planned major surgery during the study\n* History of severe bleeding tendency or coagulation dysfunction\n* History of oesophageal varices, severe ulcers, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess or acute gastrointestinal bleeding within 6 months prior to the first dose\n* Acute, chronic or symptomatic infections\n* Participants with history of immunodeficiency",{"count":50,"type":20},224,[52,23],"PHASE1","This study is testing a new medicine called PF-08634404 and how it works in adults with advanced Renal Cell Carcinoma (RCC)- a type of kidney cancer that is either locally advanced (spread to nearby tissues) or metastatic (spread to other parts of the body). The study will look at the safety of the study medicine, when given alone or with other anticancer medicines, and how this type of cancer responds to them.\n\nTo join the study, participants must be adults; with locally advanced or metastatic RCC; who have not received treatment for their advanced kidney cancer.\n\nParticipants will receive study medicine either alone or with other anticancer medicines. The medicine will be given through intravenous (IV) infusions, which means it will be injected directly into a vein. All treatments will take place at clinical study sites, where trained medical staff will take care of participants during and after each visit.",[55,56,57,58,59,60,61,62,63,64,65,27,66],"Carcinoma, Renal Cell","Advanced Renal Cell Carcinoma","Renal Cancer","Renal Neoplasm","Clear Cell Renal Cell Carcinoma","Metastatic Renal Cell Carcinoma","Clear-cell Metastatic Renal Cell Carcinoma","Carcinoma, Renal Cell Metastasis","Advanced or Metastatic Renal Cell Carcinoma","Carcinoma, Renal Cell, Advanced","Metastatic Renal Cell Cancer","Metastatic\u002FAdvanced Renal Cell Carcinoma",[68,69,70],"Renal cell carcinoma","renal cancer","renal neoplasm","2026-06-03",{"date":73,"type":33},"2026-06-04",{"date":75,"type":33},"2026-02-10",{"date":77,"type":20},"2028-11-01",{"name":79,"class":80},"Pfizer","INDUSTRY",109,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":90,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":4},"100610906","immediate-versus-deferred-cytoreductive-nephrectomy-with-ipilimumabnivolumab-in-mrcc-100610906","NCT07233668","Immediate Versus Deferred Cytoreductive Nephrectomy With Ipilimumab\u002FNivolumab in mRCC","Immediate Versus Deferred Cytoreductive Nephrectomy With Ipilimumab\u002FNivolumab in Metastatic Clear Cell Renal Cell Carcinoma: A Multicenter, Randomized, Open-Label, Phase III Trial","IVE in mRCC","Inclusion Criteria:\n\n* Participants must meet all of the following:\n* Age ≥ 19 years (male or female).\n* Histologically confirmed synchronous metastatic clear cell renal cell carcinoma.\n* ECOG performance status 0-1.\n* At least one measurable metastatic lesion (per RECIST v1.1).\n* Primary renal tumor considered surgically resectable.\n* IMDC intermediate- or poor-risk classification.\n* Estimated life expectancy \\> 3 months.\n* Ability to understand and voluntarily sign informed consent.\n\nExclusion Criteria:\n\n* Prior systemic therapy for metastatic RCC.\n* History of another malignancy diagnosed or treated within 2 years (except for cured non-melanoma skin cancer or in-situ cancers).\n* Significant comorbid conditions making participation inappropriate, such as:\n\nModerate to severe cardiovascular, cerebrovascular, pulmonary, or hepatic disease.\n\n* History or suspicion of autoimmune disease incompatible with immune checkpoint inhibitor therapy.\n* Requirement for systemic corticosteroid therapy \\>10 mg\u002Fday prednisone equivalent, or other immunosuppressive drugs.\n* Any other condition judged by the investigator to make the patient unsuitable for trial participation.","19 Years",{"count":92,"type":20},172,[94],"NA","The goal of this clinical trial is to learn whether the timing of surgery (cytoreductive nephrectomy) improves outcomes when combined with immunotherapy (ipilimumab and nivolumab) in adults with metastatic clear cell renal cell carcinoma.\n\nThe main questions this study aims to answer are:\n\n* Does upfront (immediate) surgery before immunotherapy improve survival compared to delayed surgery after immunotherapy?\n* What medical problems (side effects or complications) occur with each treatment sequence?\n* How do the two strategies affect quality of life?\n\nResearchers will compare two groups:\n\n* Upfront surgery group: Participants will have surgery first, then receive 4 cycles of ipilimumab\u002Fnivolumab, followed by nivolumab maintenance.\n* Deferred surgery group: Participants will receive 4 cycles of ipilimumab\u002Fnivolumab first, then surgery, followed by nivolumab maintenance.\n\nParticipants will:\n\n* Be randomly assigned to one of the two groups\n* Undergo regular clinic visits, imaging tests, and blood collections for safety and biomarker studies\n* Be followed for 15 months to check disease progression, complications, survival, and quality of life\n\nThis trial will help determine the best timing for surgery in the era of immunotherapy and provide evidence for improved treatment strategies for patients with metastatic kidney cancer",[27],[60,98,99,100,101],"Immune Checkpoint Inhibitor","Cytoreductive Nephrectomy","Progression-Free Survival","Randomized Clinical Trial","NOT_YET_RECRUITING","2025-11-25",{"date":105,"type":33},"2025-12-03",{"date":107,"type":20},"2025-12-01",{"date":109,"type":20},"2029-02-01",{"name":111,"class":40},"Seoul National University Hospital",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":122,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":146},"100562294","phase-2-radiotherapy-in-combination-with-checkpoint-inhibition-for-patients-with-metastatic-kidney-cancer-100562294","NCT06601296","Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer","STING Agonist and Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer.","SPARK","Inclusion Criteria:\n\n* Patients must have metastatic ccRCC.\n* Patients must have oligoprogression defined as progression in ≤5 lesions.\n* All oligoprogression lesions must be suitable for radiation.\n* Patients must have at least one site of disease that can be safely injected with IMSA101.\n* Karnofsky Performance Status (KPS) of at least 50%.\n* Age ≥ 18 years.\n* Patients must have adequate organ and marrow function within 14 days prior to study entry.\n* All IMDC risk categories are allowed.\n\nExclusion Criteria:\n\n* Patients with progressive ultracentral\u002Fcentral chest lesions will be excluded",{"count":121,"type":20},15,[23],"To evaluate the impact of combining innate immune system activation (with IMSA101) with antigen release (through SAbR\u002FPULSAR) on limited progressing lesions during ongoing adaptive immune system activation (with maintenance Nivo).",[27,125],"OligoProgressive Metastatic Disease",[127,128,129,130,131,132,133,134,118,135,136],"renal","kidney","mrcc","metastatic","cancer","STING","PULSAR","SABr","nivolumab","IMSA 101","2025-11-07",{"date":139,"type":33},"2025-11-12",{"date":141,"type":33},"2025-04-01",{"date":143,"type":20},"2028-10",{"name":145,"class":40},"University of Texas Southwestern Medical Center",1]