Spots Global Cancer Trial Database for A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma (MK-3795-001)
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Trial Identification
Brief Title: A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma (MK-3795-001)
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
Study ID: NCT02293980
Study Description
Brief 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.
Detailed Description: PART 1: This is a Phase 1, multiple-dose, dose-escalation trial of MK-3795, where patients with advanced ccRCC will be assigned to sequential dose cohorts. Patient safety will be monitored with frequent physical examinations, vital sign measurements, electrocardiograms (ECGs), and hematology and chemistry laboratory studies, and by recording all adverse events (AEs). Blood will be obtained for analysis of the concentration of MK-3795 and to assess biomarkers. PART 2: This is a Phase 1 trial of MK-3795 in combination with nivolumab, where patients with advanced ccRCC will be assigned to dose cohorts. Patient safety will be monitored with frequent physical examinations, vital sign measurements, ECGs, and hematology and chemistry laboratory studies, and by recording all AEs. Blood will be obtained for analysis of the concentration of MK-3795 and to assess biomarkers. As of Amendment 09 (29 Mar 2024), participants with advanced ccRCC will transition from MK-3795 to belzutifan in combination with nivolumab or belzutifan alone. PART 3: This is a Phase 1 trial of MK-3795 in combination with cabozantinib tablets, where patients with advanced ccRCC will be assigned to dose cohorts. Patient safety will be monitored with frequent physical examinations, vital sign measurements, ECGs, and hematology and chemistry laboratory studies, and by recording all AEs. Blood will be obtained for analysis of the concentration of MK-3795 and cabozantinb and to assess biomarkers.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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