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)

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Carcinoma, Renal Cell

In brief

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).

Key facts

Study ID

NCT05239728

Run by

Merck Sharp & Dohme LLC

People needed

1800

Starts

2022-03-15

Expected to finish

2029-09-28

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, any grade, N0, M0
• High risk RCC: pT4, any Grade N0, M0; pT any stage, any Grade, N+, M0
• 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
• Has adequate organ function

You may not qualify if…

• 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
• Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapy is allowed
• Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Has an active infection, requiring systemic therapy
• Has a known history of human immunodeficiency virus (HIV) infection, a known history of Hepatitis B or known active Hepatitis C virus infection
• Has had an allogenic tissue/solid organ transplant

Where it is running

• 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
• Moffitt Cancer Center ( Site 3540) — Tampa, Florida, United States
• Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 3515) — Marietta, Georgia, United States
• Parkview Research Center at Parkview Regional Medical Center ( Site 3526) — Fort Wayne, Indiana, United States
• Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center- GU Oncology ( Site 3549) — Baltimore, Maryland, United States
• Massachusetts General Hospital ( Site 3571) — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 3572) — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute-GU ( Site 3505) — Boston, Massachusetts, United States
• Cancer and Hematology Centers of Western Michigan ( Site 3502) — Grand Rapids, Michigan, United States
• Washington University-Internal Medicine/Oncology ( Site 3531) — St Louis, Missouri, United States
• St. Vincent Frontier Cancer Center-Research ( Site 3506) — Billings, Montana, United States
• Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 3550) — Omaha, Nebraska, United States
• Englewood Hospital and Medical Center ( Site 3557) — Englewood, New Jersey, United States
• Rutgers Cancer Institute of New Jersey ( Site 3541) — New Brunswick, New Jersey, United States
• Monter Cancer Center ( Site 3560) — Lake Success, New York, United States
• Icahn School of Medicine at Mount Sinai ( Site 3539) — New York, New York, United States
• Mayo Clinic in Arizona - Phoenix ( Site 3554) — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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