A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005) (NCT04195750)
An Open-label, Randomized Phase 3 Study of MK-6482 Versus Everolimus in Participants With Advanced Renal Cell Carcinoma That Has Progressed After Prior PD-1/L1 and VEGF-Targeted Therapies
๐ฉบ Plain-English Summary (8th-Grade Level)
The primary objective of this study is to compare belzutifan to everolimus with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and to compare everolimus with respect to overall survival (OS). The hypothesis is that belzutifan is superior to everolimus with respect to PFS and OS.
Who can join: Review the eligibility criteria below.
Location: Faculty Office Towers 1132 ( Site 1538) โ Birmingham, Alabama
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 (172 Sites)
Showing the first 25 of 172 sites.
- Faculty Office Towers 1132 ( Site 1538) โ Birmingham, Alabama
- University of California San Diego Moores Cancer Center ( Site 1546) โ La Jolla, California
- St. Joseph Heritage Healthcare Local Lab ( Site 1531) โ Santa Rosa, California
- University of Colorado Cancer Center ( Site 1540) โ Aurora, Colorado
- UCHealth Highlands Ranch Hospital ( Site 1560) โ Highlands Ranch, Colorado
- Sibley Memorial Hospital ( Site 1559) โ Washington D.C., District of Columbia
- Northwest Georgia Oncology Centers PC ( Site 1520) โ Marietta, Georgia
- The University of Chicago Medical Center ( Site 1539) โ Chicago, Illinois
- Ochsner Medical Center ( Site 1522) โ New Orleans, Louisiana
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 1514) โ Baltimore, Maryland
- Massachusetts General Hospital ( Site 1558) โ Boston, Massachusetts
- Beth Israel Deaconess Medical Center ( Site 1501) โ Boston, Massachusetts
- Dana Farber Cancer Institute ( Site 1505) โ Boston, Massachusetts
- Henry Ford Cancer Center ( Site 1511) โ Detroit, Michigan
- Hattiesburg Clinic ( Site 1509) โ Hattiesburg, Mississippi
- St. Vincent Frontier Cancer Center ( Site 1549) โ Billings, Montana
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 1513) โ Hackensack, New Jersey
- University of Rochester Medical Center ( Site 1543) โ Rochester, New York
- University of North Carolina at Chapel Hill ( Site 1537) โ Chapel Hill, North Carolina
- Oncology Hematology Care, Inc. ( Site 1524) โ Cincinnati, Ohio
- Cleveland Clinic Main ( Site 1504) โ Cleveland, Ohio
- Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1523) โ Tulsa, Oklahoma
- Oregon Health & Science University ( Site 1553) โ Portland, Oregon
- Abramson Cancer Center ( Site 1525) โ Philadelphia, Pennsylvania
- Fox Chase Cancer Center ( Site 1506) โ Philadelphia, Pennsylvania
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
- 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) โ Phoenix, Arizona
- 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.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.