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)
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)
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: Review the eligibility criteria below.
Location: Mayo Clinic in Arizona - Phoenix ( Site 3554) โ Phoenix, Arizona
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (285 Sites)
Showing the first 25 of 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
๐ Contact the Study Coordinator
Phone: (800) 664-4580
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
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.
More studies in Carcinoma, Renal Cell
- Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) โ San Francisco, California
- A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011) โ Chandler, Arizona
- Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03) โ San Francisco, California
- A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012) โ Birmingham, Alabama
- Exploring Relevant Immune-based Biomarkers and Circulating Tumor Cells During Treatment With Immunotherapy in Genitourinary Malignancies (CTC Immune Based Biomarkers) โ Durham, North Carolina
Explore by condition: All Carcinoma, Renal Cell clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.