Actively Recruiting
A Phase 3, Randomized, Open-label Study of Belzutifan Zanzalintinib Versus Cabozantinib in Participants With Advanced RCC Who Experienced Disease Recurrence During or After Prior Adjuvant Anti-PD-1L1 Therapy
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-04
904
Participants Needed
108
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Merck Sharp & Dohme LLC
Lead Sponsor
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Exelixis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating new treatments for advanced renal cell carcinoma RCC that has returned after previous therapy. This study compares the effects of two oral drug combinations belzutifan plus zanzalintinib versus cabozantinib. The aim is to find out if the combination of belzutifan and zanzalintinib helps patients live longer overall and delays cancer progression compared to cabozantinib alone. Participants in this study will be randomly assigned to one of two groups. One group will take belzutifan and zanzalintinib orally once daily, while the other group will take cabozantinib orally once daily. Treatment will continue until certain conditions require stopping. This is an open-label, phase 3 trial evaluating these treatments in people with advanced RCC who have had disease recurrence during or after prior anti-PD-1L1 therapy. During the study, participants will be monitored for progression-free survival and overall survival for up to about 73 months. Researchers will also track response rates, duration of response, side effects, and quality of life using questionnaires over about 25 months. Safety assessments and regular evaluations will be performed as part of the study. Total study participation may last several years, depending on individual circumstances and treatment continuation.
CONDITIONS
Brief Title
A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed unresectable, advanced renal cell cancer with clear cell component (Stage IV per AJCC 8th Edition)
- Measurable disease per RECIST 1.1 criteria
- Disease recurrence during adjuvant anti-PD-1/L1 therapy or within 24 months after last dose of such therapy
- No prior systemic therapy for RCC except adjuvant anti-PD-1/L1 therapy
- Age 18 years or older
You will not qualify if you...
- Clinically significant cardiovascular disease within 12 months before study intervention, including severe heart failure, unstable angina, pulmonary embolism, heart attack, stroke, or unstable arrhythmia
- Deep vein thrombosis within 3 months prior to randomization unless stable and treated with anticoagulation for at least 4 weeks
- Left ventricular ejection fraction 50% or below normal range
- Major surgery within 8 weeks before randomization or ongoing surgical complications
- Current pneumonitis or interstitial lung disease
- Symptomatic pleural effusion, ascites, or pericardial fluid requiring drainage within 4 weeks before randomization
- Gastrointestinal disorders with high risk of perforation or fistula
- Serious active nonhealing wounds, ulcers, or bone fractures
- Requirement for hemodialysis or peritoneal dialysis
- History of HIV infection
- Hepatitis B or C infection
- Pharmacologically uncompensated, symptomatic hypothyroidism
- Receipt of live or live-attenuated vaccine within 30 days before first dose of study intervention
Research Team
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