Status:
RECRUITING
A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Exelixis
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Key Trial Info
Start Date :
November 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 27 2032
Estimated Enrollment :
904 Patients enrolled
Trial Details
Trial ID
NCT07227402
Start Date
November 26 2025
End Date
February 27 2032
Last Update
March 9 2026
Active Locations (84)
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1
Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205)
Caba, Buenos Aires, Argentina, C1419AHN
2
Instituto Alexander Fleming ( Site 0202)
CABA, Buenos Aires, Argentina, C1426ANZ
3
Sanatorio Parque ( Site 0201)
Rosario, Santa Fe Province, Argentina, S2000DSV
4
Instituto de Oncología de Rosario ( Site 0209)
Rosario, Santa Fe Province, Argentina, S2000KZE