A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)
NCT ID: NCT07227402
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
904 participants
INTERVENTIONAL
2025-12-29
2032-02-27
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Belzutifan plus Zanzalintinib
Participants will receive belzutifan orally once daily (QD) PLUS zanzalintinib orally QD until one of the reasons for discontinuation of study intervention are met.
Belzutifan
Administered orally QD
Zanzalintinib
Administered orally QD
Cabozantinib
Participants will receive cabozantinib orally QD until one of the reasons for discontinuation of study intervention are met.
Cabozantinib
Administered orally QD
Interventions
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Belzutifan
Administered orally QD
Zanzalintinib
Administered orally QD
Cabozantinib
Administered orally QD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
18 Years
ALL
No
Sponsors
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Exelixis
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Related Links
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Merck Clinical Trials Information
Other Identifiers
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U1111-1311-6892
Identifier Type: REGISTRY
Identifier Source: secondary_id
2024-517136-21
Identifier Type: REGISTRY
Identifier Source: secondary_id
6482-033
Identifier Type: -
Identifier Source: org_study_id