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) (NCT05239728)
๐ฉบ Plain-English Summary (8th-Grade Level)
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).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (16 items).
Location: Mayo Clinic in Arizona - Phoenix ( Site 3554) โ Phoenix, Arizona
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
- 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
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (285 Sites)
- Mayo Clinic in Arizona - Phoenix ( Site 3554) โ Phoenix, Arizona
- City of Hope Comprehensive Cancer Center ( Site 3567) โ Duarte, California
- Moores Cancer Center-Clinical Trials Office- Genitourinary ( Site 3516) โ La Jolla, California
- UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 3520) โ Los Angeles, California
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3518) โ Orange, California
- Stanford Cancer Center ( Site 3523) โ Palo Alto, California
- University of Colorado Anschutz Medical Campus ( Site 3514) โ Aurora, Colorado
- Intermountain Health St. Mary's Regional Hospital ( Site 3562) โ Grand Junction, Colorado
- Georgetown University Medical Center ( Site 3534) โ Washington D.C., District of Columbia
- University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 3517) โ Miami, Florida
- Moffitt Cancer Center ( Site 3540) โ Tampa, Florida
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 3515) โ Marietta, Georgia
- Parkview Research Center at Parkview Regional Medical Center ( Site 3526) โ Fort Wayne, Indiana
- Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center- GU Oncology ( Site 3549) โ Baltimore, Maryland
- Massachusetts General Hospital ( Site 3571) โ Boston, Massachusetts
- Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 3572) โ Boston, Massachusetts
- Dana-Farber Cancer Institute-GU ( Site 3505) โ Boston, Massachusetts
- Cancer and Hematology Centers of Western Michigan ( Site 3502) โ Grand Rapids, Michigan
- Washington University-Internal Medicine/Oncology ( Site 3531) โ St Louis, Missouri
- St. Vincent Frontier Cancer Center-Research ( Site 3506) โ Billings, Montana
- Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 3550) โ Omaha, Nebraska
- Englewood Hospital and Medical Center ( Site 3557) โ Englewood, New Jersey
- Rutgers Cancer Institute of New Jersey ( Site 3541) โ New Brunswick, New Jersey
- Monter Cancer Center ( Site 3560) โ Lake Success, New York
- Icahn School of Medicine at Mount Sinai ( Site 3539) โ New York, New York
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.