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) (NCT04736706)
An Open-label, Randomized Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or MK-1308A in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, as First-Line Treatment in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
๐ฉบ Plain-English Summary (8th-Grade Level)
The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC). The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants.
Who can join: Review the eligibility criteria below.
Location: The University of Alabama at Birmingham ( Site 0010) 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 (262 Sites)
Showing the first 25 of 262 sites.
- The University of Alabama at Birmingham ( Site 0010) โ Birmingham, Alabama
- UC San Diego ( Site 0050) โ La Jolla, California
- Cedars Sinai Medical Center ( Site 0027) โ Los Angeles, California
- University of California Irvine ( Site 0029) โ Orange, California
- UCLA Hematology Oncology Santa Monica ( Site 0048) โ Santa Monica, California
- Hartford Hospital ( Site 0024) โ Hartford, Connecticut
- Advent Health Hematology & Oncology ( Site 0003) โ Orlando, Florida
- University Cancer & Blood Center, LLC ( Site 0057) โ Athens, Georgia
- Emory University Winship Cancer Institute ( Site 0012) โ Atlanta, Georgia
- Rush University Medical Center ( Site 0040) โ Chicago, Illinois
- Parkview Cancer Institute ( Site 0088) โ Fort Wayne, Indiana
- Norton Cancer Institute - St. Matthews ( Site 0065) โ Louisville, Kentucky
- Ochsner Medical Center ( Site 0049) โ New Orleans, Louisiana
- New England Cancer Specialists ( Site 0082) โ Scarborough, Maine
- Massachusetts General Hospital ( Site 0094) โ Boston, Massachusetts
- Beth Israel Deaconess Medical Center ( Site 0089) โ Boston, Massachusetts
- Dana Farber Cancer Institute ( Site 0093) โ Boston, Massachusetts
- Lahey Hospital & Medical Center ( Site 0090) โ Burlington, Massachusetts
- Henry Ford Hospital ( Site 0038) โ Detroit, Michigan
- Cancer & Hematology Centers of Western Michigan ( Site 0018) โ Grand Rapids, Michigan
- HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0005) โ Saint Louis Park, Minnesota
- Regions Hospital ( Site 0095) โ Saint Paul, Minnesota
- University of Mississippi Medical Center ( Site 0037) โ Jackson, Mississippi
- Dartmouth Hitchcock Medical Center ( Site 0075) โ Lebanon, New Hampshire
- Roswell Park Cancer Institute ( Site 0032) โ Buffalo, 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.
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 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.