A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study ID
NCT03634540
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Belzutifan — DRUG
    Belzutifan tablets administered orally.
  • Cabozantinib — DRUG
    Cabozantinib tablets administered orally.

Study Details

This is an open-label Phase 2 study which will evaluate the efficacy and safety of belzutifan in combination with cabozantinib in participants with advanced ccRCC. Belzutifan and cabozantinib will be administered orally once daily.

Key Dates

Start date
Sep 27, 2018
Status verified
Dec 2024
Primary completion
Feb 26, 2027
Completion
Feb 26, 2027

Study Design

Enrollment
118 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Belzutifan + Cabozantinib: Treatment Naïve (Cohort 1)
    Naïve participants will receive 120 mg belzutifan and 60 mg cabozantinib orally once daily (QD) at the same time.
  • Experimental: Belzutifan + Cabozantinib: Prior Immunotherapy (Cohort 2)
    Participants who have received prior immunotherapy will receive 120 mg belzutifan and 60 mg cabozantinib orally QD at the same time.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to approximately 2 years ]

Locations (10)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0003)Los AngelesCalifornia90048-
USC Norris Comprehensive Cancer Center ( Site 0060)Los AngelesCalifornia90033-
Sylvester Comprehensive Cancer Center ( Site 0023)MiamiFlorida33136-
Dana Farber Cancer Center ( Site 0006)BostonMassachusetts02215-
Karmanos Cancer Institute ( Site 0033)DetroitMichigan48201-
Tennessee Oncology, PLLC ( Site 0024)ChattanoogaTennessee37404-
Tennessee Oncology, PLLC ( Site 0001)NashvilleTennessee37203-
Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 0010)DallasTexas75246-
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0035)SeattleWashington98109-
Swedish Cancer Institute ( Site 0018)SeattleWashington98104-

Find similar trials in Los Angeles, CA

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute· Los Angeles, CAUSC Norris Comprehensive Cancer Center· Los Angeles, CASylvester Comprehensive Cancer Center· Miami, FLDana Farber Cancer Center· Boston, MAKarmanos Cancer Institute· Detroit, MITennessee Oncology, PLLC· Chattanooga, TN

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