Ireland
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Active, not recruiting Phase 1

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

NCT02293980 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2014-11-25
Last updated
2024-06-17

Condition(s) studied

ccRCCRCCKidney CancerClear Cell Renal Cell CarcinomaRenal Cell Carcinoma

Investigational drug(s) / intervention(s)

MK-3795Nivolumab →Cabozantinib →Bezlutifan →

MK-3795: Oral administration

Nivolumab: IV infusion

Cabozantinib: Oral administration

Bezlutifan: Oral administration

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Maximum Tolerated Dose (MTD) — Part 1: 3 Weeks, Part 2: 4 Weeks, Part 3: 4 Weeks
    MTD of MK-3795 will be determined. MTD will be defined as the dose level at which 2 or more participants experience a dose limiting toxicity (DLT) which will be deemed intolerable and the dose level below will be declared the MTD.
  • Recommended Phase 2 Dose (RP2D) — Part 1: 3 Weeks; Part 2: 4 Weeks, Part 3: 4 Weeks
    The RP2D of MK-3795 will be determined. The RP2D will be determined based on the MTD (or the optimal biological dose (OBD) if the MTD is not identified), the overall safety profile with continued treatment, and pharmacokinetic (PK) profile.

Trial sites (25)

FacilityCityRegionStatus
Cedars-Sinai Medical Center Los Angeles California
University of Colorado Cancer Center Aurora Colorado
Yale School of Medicine New Haven Connecticut
University of Miami - Sylvester Comprehensive Cancer Center Miami Florida
Emory University Winship Cancer Institue Atlanta Georgia
Rush University Medical Center Chicago Illinois
Indiana University Simon Cancer Center Indianapolis Indiana
University of Maryland - Greenebaum Cancer Center Baltimore Maryland
Massachusetts General Hospital - Cancer Center Boston Massachusetts
Beth Israel Deconess Medical Center Boston Massachusetts
Dana-Farber Cancer Institute Boston Massachusetts
Barbara Ann Karmanos Cancer Institute Detroit Michigan
Mount Sinai Heath System New York New York
Cleveland Clinic Cleveland Ohio
The Ohio State University Columbus Ohio
Fox Chase Cancer Center Philadelphia Pennsylvania
University of Pittsburg Medical Center Pittsburgh Pennsylvania
The West Clinic Germantown Tennessee
Tennessee Oncology Nashville Tennessee
Vanderbilt Medical Center Nashville Tennessee
UT Southwestern Medical Center Dallas Texas
Virginia Cancer Specialists Fairfax Virginia
Swedish Cancer Institute Seattle Washington
University of Washington Seattle Washington
Medical College of Wisconsin Milwaukee Wisconsin
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02293980 on ClinicalTrials.gov ↗ ← All trials in the USA