Kidney Cancer Clinical Trial

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

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.

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria

PART 1

Has locally advanced or metastatic clear cell renal cell carcinoma (ccRCC) and has progressed during treatment with at least one prior therapeutic regimen
Has a life expectancy of ≥ 3 months
Has adequate organ function
Able to swallow oral medications

PART 2 - In addition to PART 1

Received no more than three prior systemic treatment regimens in the advanced or metastatic setting
Must have received at least one but not more than two prior anti-angiogenic therapy regimens

PART 3 - In addition to PART 1

Must have received at least one vascular endothelial growth factor receptor (VEGFR) targeting tyrosine kinase inhibitor

Exclusion Criteria

PART 1

Has a history of untreated brain metastasis or history of leptomeningeal disease or spinal cord compression
Has failed to recover from the reversible effects of prior anticancer therapy
Has uncontrolled or poorly controlled hypertension
Is receiving warfarin anticoagulant therapy or expected to require warfarin
Has had any major cardiovascular event within 6 months prior to study drug administration
Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results
Has had major surgery within 4 weeks before first study drug administration
Has known human immunodeficiency virus (HIV) infection
Has an active infection requiring systemic treatment
Is participating in another therapeutic clinical trial

PART 2 - In addition to PART 1

Has received prior immunotherapy
Has any active or recent history of a known or suspected autoimmune disease

PART 3 - In addition to PART 1

Has gastrointestinal (GI) disorders
Has any history of congenital long QT syndrome

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

110

Study ID:

NCT02293980

Recruitment Status:

Active, not recruiting

Sponsor:

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

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There are 24 Locations for this study

See Locations Near You

Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
University of Colorado Cancer Center
Aurora Colorado, 80045, United States
Yale School of Medicine
New Haven Connecticut, 06510, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
Emory University Winship Cancer Institue
Atlanta Georgia, 30322, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Indiana University Simon Cancer Center
Indianapolis Indiana, 46202, United States
University of Maryland - Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
Massachusetts General Hospital - Cancer Center
Boston Massachusetts, 02114, United States
Beth Israel Deconess Medical Center
Boston Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Mount Sinai Heath System
New York New York, 10019, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
The Ohio State University
Columbus Ohio, 43210, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
University of Pittsburg Medical Center
Pittsburgh Pennsylvania, 15232, United States
The West Clinic
Germantown Tennessee, 38138, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States
Vanderbilt Medical Center
Nashville Tennessee, 37232, United States
UT Southwestern Medical Center
Dallas Texas, 75239, United States
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
University of Washington
Seattle Washington, 98109, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

110

Study ID:

NCT02293980

Recruitment Status:

Active, not recruiting

Sponsor:


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

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