A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT04586231
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Carcinoma, Renal Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belzutifan — DRUG
    Immediate-release 40 mg tablet
  • Lenvatinib — DRUG
    Capsule available in 4 mg and 10 mg dosages
  • Cabozantinib — DRUG
    Tablet available in 20 mg, 40 mg and 60 mg dosages

Study Details

This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival.

Key Dates

Start date
Feb 25, 2021
Status verified
May 2026
Primary completion
Feb 2, 2026
Completion
Feb 11, 2027

Study Design

Enrollment
747 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Belzutifan + Lenvatinib
    Belzutifan 120 mg and lenvatinib 20 mg orally once a day
  • Active Comparator: Cabozantinib
    Cabozantinib 60 mg orally once a day

Primary Outcome Measure

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) [ Time Frame: Up to approximately 34 months ]

Locations (33)

FacilityCityStateZIPSite coordinators
Ironwood Cancer & Research Centers ( Site 0077)ChandlerArizona85224-
Cedars Sinai Medical Center ( Site 0027)Los AngelesCalifornia90048-
UCLA Hematology/Oncology - Santa Monica ( Site 0048)Los AngelesCalifornia90404-
St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0095)OrangeCalifornia92868-
University of California, Irvine ( Site 0029)OrangeCalifornia92868-
Providence Saint John's Health Center ( Site 0083)Santa MonicaCalifornia90404-
Georgetown University Medical Center ( Site 0006)Washington D.C.District of Columbia20007-
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0003)OrlandoFlorida32804-
Orlando Health, Inc. ( Site 0035)OrlandoFlorida32806-
University Cancer & Blood Center, LLC ( Site 0057)AthensGeorgia30607-
Emory University Hospital ( Site 0012)AtlantaGeorgia30322-
Rush University Medical Center ( Site 0040)ChicagoIllinois60607-
Illinois Cancer Care, PC ( Site 0008)PeoriaIllinois61615-
Parkview Cancer Institute ( Site 0088)Fort WayneIndiana46845-
Norton Cancer Institute - St. Matthews ( Site 0065)LouisvilleKentucky40207-
Tulane University School of Medicine ( Site 0098)New OrleansLouisiana70112-
Lahey Hospital & Medical Center ( Site 0090)BurlingtonMassachusetts01805-
Cancer & Hematology Centers of Western Michigan ( Site 0018)Grand RapidsMichigan49503-
HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0005)Saint Louis ParkMinnesota55426-
University of Mississippi Medical Ctr ( Site 0037)JacksonMississippi39213-
Cancer Partners of Nebraska ( Site 0086)LincolnNebraska68516-
Rutgers Cancer Institute of New Jersey ( Site 0078)New BrunswickNew Jersey08903-
R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0013)Lake SuccessNew York11042-
Memorial Sloan Kettering Cancer Center ( Site 0055)New YorkNew York10065-
Levine Cancer Institute ( Site 0004)CharlotteNorth Carolina28204-
Duke Cancer Institute ( Site 0096)DurhamNorth Carolina27710-
Lehigh Valley Hospital- Cedar Crest-Oncology Clinical Trials ( Site 0056)AllentownPennsylvania18103-
University of Texas, Southwestern Medical Center ( Site 0015)DallasTexas75235-
Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 7001)Salt Lake CityUtah84112-
University of Vermont Medical Center ( Site 0001)BurlingtonVermont05401-
Blue Ridge Cancer Care - Roanoke ( Site 0043)RoanokeVirginia24014-
Seattle Cancer Care Alliance-Renal/Melanoma/MCC ( Site 0093)SeattleWashington98109-
Central Washington Health Services Association d/b/a Confluence Health ( Site 0061)WenatcheeWashington98801-

Find similar trials in Chandler, AZ

By research site
Ironwood Cancer & Research Centers· Chandler, AZCedars Sinai Medical Center· Los Angeles, CAUCLA Hematology/Oncology - Santa Monica· Los Angeles, CASt. Joseph Hospital-The Center for Cancer Prevention and Treatment· Orange, CAUniversity of California, Irvine· Orange, CAProvidence Saint John's Health Center· Santa Monica, CA

Related Studies