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A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma (MK-3795-001)
NCT02293980 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Cabozantinib
- DRUG MK-3795
- DRUG Bezlutifan
Study Locations (20)
Massachusetts
- Massachusetts General Hospital - Cancer Center — Boston
- Beth Israel Deconess Medical Center — Boston
- Dana-Farber Cancer Institute — Boston
Tennessee
- The West Clinic — Germantown
- Tennessee Oncology — Nashville
- Vanderbilt Medical Center — Nashville
Ohio
- Cleveland Clinic — Cleveland
- The Ohio State University — Columbus
Pennsylvania
- Fox Chase Cancer Center — Philadelphia
- University of Pittsburg Medical Center — Pittsburgh
California
- Cedars-Sinai Medical Center — Los Angeles
Colorado
- University of Colorado Cancer Center — Aurora
Connecticut
- Yale School of Medicine — New Haven
Florida
- University of Miami - Sylvester Comprehensive Cancer Center — Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2014-11-25 |
| Est. Completion | 2026-11-30 |
| Phase | Phase 1 |
Sponsor
Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)4 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02293980
The ClinicalTrials.gov registry entry for NCT02293980 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 4 interventions — of which Nivolumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02293980 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Massachusetts, Tennessee, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02293980 about?
NCT02293980 is a clinical study titled "A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma (MK-3795-001)". 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 i...
What is the current status of trial NCT02293980?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 110 participants. The study started on 2014-11-25. Estimated completion is 2026-11-30.
What conditions does trial NCT02293980 study?
This clinical trial studies the following conditions: Renal Cell Carcinoma, Kidney Cancer, Clear Cell Renal Cell Carcinoma, RCC, ccRCC. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02293980?
The interventions under investigation include: Nivolumab (DRUG), Cabozantinib (DRUG), MK-3795 (DRUG), Bezlutifan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02293980?
This trial is sponsored by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02293980 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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