A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma (MK-3795-001)

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
NCT02293980
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • MK-3795 — DRUG
    Oral administration
  • Nivolumab — DRUG
    IV infusion
  • Cabozantinib — DRUG
    Oral administration
  • Bezlutifan — DRUG
    Oral administration

Study Details

PART 1: The primary objective of this study is to identify the maximum tolerated dose (MTD) of MK-3795, formerly called PT2385 and/or the recommended Phase 2 dose (RP2D) of MK-3795 in patients with advanced clear cell renal cell carcinoma (ccRCC). PART 2: The primary objective of this study is to identify the MTD of MK-3795 up to the RP2D, in combination with nivolumab, in patients with advanced ccRCC.As of Amendment 09 (29 Mar 2024), participants with advanced ccRCC will transition from MK-3795 to belzutifan (MK-6482) in combination with nivolumab or belzutifan alone. PART 3: The primary objective of this study is to identify the MTD of MK-3795 up to the RP2D, in combination with cabozantinib tablets, in patients with advanced ccRCC.

Key Dates

Start date
Nov 25, 2014
Status verified
May 2024
Primary completion
Jan 31, 2017
Completion
Nov 30, 2026

Study Design

Enrollment
110 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: MK-3795
    Participants with advanced ccRCC receive MK-3795 at an initial dose level of 100mg orally, twice daily (BID) up to approximately 3 weeks. Dose levels will be escalated to identify the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) for MK-3795. Each escalated dose will be continued for up to approximately 3 weeks before escalating a dose again until a dose limiting toxicity (DLT) is experienced. Thereafter, participants receive RP2D dose of MK-3795 for up to 2 cycles (each cycle length = 28 days) for up to approximately 1 year. Participants may continue to receive MK-3795 beyond 1 year at the discretion of the Sponsor.
  • Experimental: Part 2: MK-3795 + Nivolumab + Belzutifan
    Participants with advanced ccRCC in the expansion phase receive the RP2D of MK-3795 orally in combination with nivolumab 240mg by IV infusion over \~60 minutes every 2 weeks for up to \~1 year (12 cycles; each cycle length = 28 days) or until unequivocal progression or treatment discontinuation, whichever occurs later. As per Amendment 09 (29 March 2024), participants will not receive MK-3795. Participants receive nivolumab 240mg by IV infusion over \~60 minutes every 2 weeks in combination with belzutifan 120 mg once daily (QD) for up to \~1 year (12 cycles; each cycle length = 28 days) or until unequivocal progression or treatment discontinuation, whichever occurs later. If participants experience an adverse event, then nivolumab will be discontinued and participants will continue to receive belzutifan 120 mg QD alone for up to \~1 year (12 cycles; each cycle length = 28 days) or until unequivocal progression or treatment discontinuation, whichever occurs later.
  • Experimental: Part 3: MK-3795 + Cabozantinib
    Participants with advanced ccRCC in the expansion phase receive the RP2D of MK-3795 in combination with cabozantinib 20mg up to 60mg orally QD for up to approximately 1 year (12 cycles; each cycle length = 28 days) or until unequivocal progression or treatment discontinuation, whichever occurs later.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: Part 1: 3 Weeks, Part 2: 4 Weeks, Part 3: 4 Weeks ]

Locations (25)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
University of Colorado Cancer CenterAuroraColorado80045-
Yale School of MedicineNew HavenConnecticut06510-
University of Miami - Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Emory University Winship Cancer InstitueAtlantaGeorgia30322-
Rush University Medical CenterChicagoIllinois60612-
Indiana University Simon Cancer CenterIndianapolisIndiana46202-
University of Maryland - Greenebaum Cancer CenterBaltimoreMaryland21201-
Beth Israel Deconess Medical CenterBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General Hospital - Cancer CenterBostonMassachusetts02114-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
Mount Sinai Heath SystemNew YorkNew York10019-1147-
Cleveland ClinicClevelandOhio44195-
The Ohio State UniversityColumbusOhio43210-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
University of Pittsburg Medical CenterPittsburghPennsylvania15232-
The West ClinicGermantownTennessee38138-
Tennessee OncologyNashvilleTennessee37203-
Vanderbilt Medical CenterNashvilleTennessee37232-
UT Southwestern Medical CenterDallasTexas75239-
Virginia Cancer SpecialistsFairfaxVirginia22031-
Swedish Cancer InstituteSeattleWashington98104-
University of WashingtonSeattleWashington98109-
Medical College of WisconsinMilwaukeeWisconsin53226-

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