NCT07227402 A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)
| NCT ID | NCT07227402 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Merck Sharp & Dohme LLC |
| Condition | Renal Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 904 participants |
| Start Date | 2025-11-26 |
| Primary Completion | 2032-02-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 904 participants in total. It began in 2025-11-26 with a primary completion date of 2032-02-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 or goes away) after treatment with belzutifan (MK-6482) and zanzalintinib compared to cabozantinib. 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.
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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 * Has pharmacologically uncompensated, symptomatic hypothyroidism * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Contact & Investigator
Medical Director
STUDY DIRECTOR
Merck Sharp & Dohme LLC
Frequently Asked Questions
Who can join the NCT07227402 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07227402 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 904 participants.
Is NCT07227402 currently recruiting?
Yes, NCT07227402 is actively recruiting participants. Contact the research team at Trialsites@msd.com for enrollment information.
Where is the NCT07227402 trial being conducted?
This trial is being conducted at Anchorage, United States, Fullerton, United States, Westbrook, United States, Baltimore, United States and 11 additional locations.
Who is sponsoring the NCT07227402 clinical trial?
NCT07227402 is sponsored by Merck Sharp & Dohme LLC. The principal investigator is Medical Director at Merck Sharp & Dohme LLC. The trial plans to enroll 904 participants.