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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

Useful links and downloads for this trial

Clinicaltrials.gov

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