Clinical Research Directory
Browse clinical research sites, groups, and studies.
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)
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
MK-3795
Oral administration
Nivolumab
IV infusion
Cabozantinib
Oral administration
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