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ACTIVE NOT RECRUITING
NCT02293980
PHASE1

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

Sponsor: Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 1, Multiple-Dose, Dose-Escalation Trial of PT2385 Tablets, a HIF-2α Inhibitor, in Patients With Advanced Clear Cell Renal Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2014-11-25

Completion Date

2026-11-30

Last Updated

2024-06-17

Healthy Volunteers

No

Interventions

DRUG

MK-3795

Oral administration

DRUG

Nivolumab

IV infusion

DRUG

Cabozantinib

Oral administration

DRUG

Bezlutifan

Oral administration

Locations (25)

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Yale School of Medicine

New Haven, Connecticut, United States

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Emory University Winship Cancer Institue

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Indiana University Simon Cancer Center

Indianapolis, Indiana, United States

University of Maryland - Greenebaum Cancer Center

Baltimore, Maryland, United States

Massachusetts General Hospital - Cancer Center

Boston, Massachusetts, United States

Beth Israel Deconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Mount Sinai Heath System

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, United States

The West Clinic

Germantown, Tennessee, United States

Tennessee Oncology

Nashville, Tennessee, United States

Vanderbilt Medical Center

Nashville, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Swedish Cancer Institute

Seattle, Washington, United States

University of Washington

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States