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

Running, not enrolling · Phase 1

Conditions studied: ccRCC, RCC, Kidney Cancer, Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT02293980

Run by

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

People needed

110

Starts

2014-11-25

Expected to finish

2026-11-30

Last updated by the study team

2024-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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