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A clinical study of belzutifan and zanzalintinib in people with advanced kidney cancer (MK-6482-034)
EU CTIS ID: 2024-516993-31-00
What this study is testing
1. To compare belzutifan + zanzalintinib to belzutifan + placebo with respect to PFS per RECIST 1.1 as assessed by BICR 2. To compare belzutifan + zanzalintinib to belzutifan + placebo 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 carcinoma (RCC) with clear cell component (with or without sarcomatoid features) ie, Stage IV RCC per American Joint Committee on Cancer (8th Edition)
- Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1
- Has received no more than 3 prior systemic regimens for RCC, including only 1 prior anti-Programmed Cell Death-1/Programmed Cell Death 1 Ligand 1 therapy
You likely can't join if
- Has any of the following: a pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or required chronic supplemental oxygen
- Has a history of solid organ transplant
- Has not adequately recovered from major surgery or has ongoing surgical complications
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
- Has 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
See the full eligibility criteria
- Has a histologically confirmed diagnosis of unresectable, advanced renal cell carcinoma (RCC) with clear cell component (with or without sarcomatoid features) ie, Stage IV RCC per American Joint Committee on Cancer (8th Edition)
- Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1
- Has received no more than 3 prior systemic regimens for RCC, including only 1 prior anti-Programmed Cell Death-1/Programmed Cell Death 1 Ligand 1 therapy
- Has any of the following: a pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or required chronic supplemental oxygen
- Has a history of solid organ transplant
- Has not adequately recovered from major surgery or has ongoing surgical complications
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
- Has 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
- Has current pneumonitis/interstitial lung disease
- Has a history of human immunodeficiency virus infection
- Has Hepatitis B or Hepatitis C virus infection
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- Canada
- Korea, Republic of
- United States
- Israel
- Chile
- United Kingdom
- Argentina
- Australia
- Brazil
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; Canada; Korea, Republic of; United States; Israel; Chile and 4 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.