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A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)

A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (MK-6482-022)

NCT05239728•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy. The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has a histologically or cytologically confirmed diagnosis of RCC with clear cell component per American Joint Committee on Cancer (AJCC) (8th Edition), with or without sarcomatoid features
•Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading:
•1. Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, any grade, N0, M0
•2. High risk RCC: pT4, any Grade N0, M0; pT any stage, any Grade, N+, M0
•3. M1 NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, ≤2 years from nephrectomy (metachronous)
•Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants
•Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization
•Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days before randomization.
•Male participants must agree to continue contraception at least 7 days after the last dose of belzutifan/placebo
•Female participants of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of pembrolizumab or at least 30 days after last dose of belzutifan/placebo, whichever occurs last
+1 more criteria

Exclusion Criteria

•Has had a major surgery, other than nephrectomy plus resection of preexisting metastases for M1 NED participants, within 4 weeks prior to randomization
•Has a pulse oximeter reading \<92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
•Has clinically significant cardiovascular disease within 6 months from first dose of study intervention
•Has other clinically significant disorders such as: serious active nonhealing wound/ulcer/bone fracture; requirement for hemodialysis or peritoneal dialysis
•Has preexisting brain or bone metastatic lesions
•Has received prior systemic therapy for RCC
•Has received prior radiotherapy for RCC
•Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention; administration of killed vaccines are allowed
•Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
•Has a known additional malignancy (other than RCC treated with nephrectomy and/or metastasectomy) that is progressing or has required active treatment within the past 3 years
+5 more criteria

Locations (285)

Mayo Clinic in Arizona - Phoenix ( Site 3554)

Phoenix, Arizona, United States

City of Hope Comprehensive Cancer Center ( Site 3567)

Duarte, California, United States

Moores Cancer Center-Clinical Trials Office- Genitourinary ( Site 3516)

La Jolla, California, United States

UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 3520)

Los Angeles, California, United States

University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3518)

Orange, California, United States

Stanford Cancer Center ( Site 3523)

Palo Alto, California, United States

University of Colorado Anschutz Medical Campus ( Site 3514)

Aurora, Colorado, United States

Intermountain Health St. Mary's Regional Hospital ( Site 3562)

Grand Junction, Colorado, United States

Georgetown University Medical Center ( Site 3534)

Washington D.C., District of Columbia, United States

University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 3517)

Miami, Florida, United States

Key Dates

Start Date

March 15, 2022

Primary Completion Date

October 28, 2026

Completion Date

September 28, 2029

Last Updated

August 14, 2025

Enrollment

1,800

ESTIMATED participants

Conditions

Carcinoma, Renal Cell

Interventions

Belzutifan

DRUG

Pembrolizumab

BIOLOGICAL

Placebo

DRUG

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NCT07227415

Carcinoma, Renal CellAdvanced Renal Cell Carcinoma+11 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer

Autologous Dendritic Cell Vaccine in Kidney Cancer

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