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A clinical study of belzutifan and zanzalintinib in people with advanced kidney cancer (MK-6482-033)
EU CTIS ID: 2024-517136-21-00
What this study is testing
1. To compare belzutifan + zanzalintinib to cabozantinib with respect to PFS per RECIST 1.1 as assessed by BICR. 2. To compare belzutifan + zanzalintinib to cabozantinib with respect to OS.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has a histologically confirmed diagnosis of unresectable, advanced renal cell cancer (RCC) with clear cell component (with or without sarcomatoid features) ie, Stage IV renal cell cancer per 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 likely can't join if
- 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.
- Has a requirement for hemodialysis or peritoneal dialysis.
- Has history of human immunodeficiency virus infection.
- Has hepatitis B or hepatitis C virus.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- Had deep vein thrombosis within 3 months before randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before randomization.
See the full eligibility criteria
- Has a histologically confirmed diagnosis of unresectable, advanced renal cell cancer (RCC) with clear cell component (with or without sarcomatoid features) ie, Stage IV renal cell cancer per 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.
- 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.
- Has a requirement for hemodialysis or peritoneal dialysis.
- Has history of human immunodeficiency virus infection.
- Has hepatitis B or hepatitis C virus.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- 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 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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Australia
- Mexico
- United Kingdom
- Korea, Republic of
- Brazil
- Canada
- Singapore
- Argentina
- Hong Kong
- Taiwan
- Chile
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Australia; Mexico; United Kingdom; Korea, Republic of; Brazil and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.