A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)
Recruiting now · Phase 3
Conditions studied: Renal Cell Carcinoma
In brief
Researchers are looking for more ways to treat advanced renal cell carcinoma (RCC) that is recurrent. Researchers want to learn if recurrent advanced renal cell carcinoma (RCC) responds (gets smaller or goes away) after treatment with belzutifan (MK-6482) and zanzalintinib compared to cabozantinib. The goal of this study is to learn if: People who take belzutifan and zanzalintinib live longer overall and without the cancer getting worse than people who take cabozantinib.
Key facts
- Study ID
- NCT07227402
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 904
- Starts
- 2025-11-26
- Expected to finish
- 2032-02-27
- Last updated by the study team
- 2026-08-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The main inclusion criteria include but are not limited to the following:
- Has a histologically confirmed diagnosis of unresectable, advanced renal cell cancer (RCC) with clear cell component (with or without sarcomatoid features) i.e., Stage IV renal cell cancer per American Joint Committee on Cancer (AJCC) (8th Edition)
- Has measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
- Has disease recurrence during adjuvant anti-programmed cell death 1/programmed cell death ligand 1 (PD-1/L1) therapy or recurrence ≤24 months following the last dose of adjuvant anti-PD-1/L1 therapy
- Has received no other prior systemic therapy for their RCC except for their adjuvant anti-PD-1/L1 therapy
You may not qualify if…
- The main exclusion criteria include but are not limited to the following:
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, new-onset angina, pulmonary embolism, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
- Had deep vein thrombosis within 3 months before randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before randomization
- Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition or echocardiogram
- Has had major surgery within 8 weeks before randomization or has not adequately recovered from major surgery or has ongoing surgical complications
- Has current pneumonitis/interstitial lung disease
- Has symptomatic pleural effusion (for example cough, dyspnea, pleuritic chest pain), ascites, or pericardial fluid requiring drainage within 4 weeks prior to randomization
- Has a gastrointestinal disorder including those associated with a high risk of perforation or fistula formation
- Has a serious active nonhealing wound/ulcer/bone fracture
- Has a requirement for hemodialysis or peritoneal dialysis
- Has history of human immunodeficiency virus infection
- Has hepatitis B or hepatitis C virus
- Has pharmacologically uncompensated, symptomatic hypothyroidism
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Where it is running
- Providence Medical Foundation ( Site 0141) — Fullerton, California, United States (enrolling)
- USC Norris Comprehensive Cancer Center ( Site 0126) — Los Angeles, California, United States (enrolling)
- Cedars-Sinai Medical Center ( Site 0112) — Los Angeles, California, United States (enrolling)
- New England Cancer Specialists ( Site 0132) — Westbrook, Maine, United States (enrolling)
- Greater Baltimore Medical Center ( Site 0145) — Baltimore, Maryland, United States (enrolling)
- Metro-Minnesota Community Clinical Oncology ( Site 0144) — Saint Louis Park, Minnesota, United States (enrolling)
- Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0131) — Omaha, Nebraska, United States (enrolling)
- Carolina Oncology Specialists, PA ( Site 9002) — Charlotte, North Carolina, United States (enrolling)
- Thompson Cancer Survival Center ( Site 0125) — Knoxville, Tennessee, United States (enrolling)
- Hospital Aleman ( Site 0204) — CABA, Buenos Aires, Argentina (enrolling)
- Hospital Italiano de Buenos Aires. ( Site 0203) — Caba, Buenos Aires, Argentina (enrolling)
- Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205) — Caba, Buenos Aires, Argentina (enrolling)
- Instituto Alexander Fleming ( Site 0202) — CABA, Buenos Aires, Argentina (enrolling)
- Hospital Universitario Austral ( Site 0212) — Pilar, Buenos Aires, Argentina (enrolling)
- Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0208) — Caba., Buenos Aires F.D., Argentina (enrolling)
- Sanatorio Parque ( Site 0201) — Rosario, Santa Fe Province, Argentina (enrolling)
- Instituto de Oncología de Rosario ( Site 0209) — Rosario, Santa Fe Province, Argentina (enrolling)
- Hospital Privado Universitario de Córdoba ( Site 0207) — Córdoba, Argentina (enrolling)
- Macquarie University-MQ Health Clinical Trials Unit ( Site 2100) — Sydney, New South Wales, Australia (enrolling)
- Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0600) — Linz, Upper Austria, Austria (enrolling)
- Medizinische Universitat Wien ( Site 0601) — Vienna, Austria (enrolling)
- Cliniques Universitaires Saint-Luc ( Site 0703) — Brussels, Bruxelles-Capitale, Region de, Belgium (enrolling)
- Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 0701) — Genk, Limburg, Belgium (enrolling)
- UZ Gent ( Site 0702) — Ghent, Oost-Vlaanderen, Belgium (enrolling)
- Alaska Oncology and Hematology ( Site 0133) — Anchorage, Alaska, United States (enrolling)
Full record on ClinicalTrials.gov
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