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NCT02293980 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Renal Cell Carcinoma and Kidney Cancer, sponsored by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

Active
Registry status
Phase 1
Development phase
110
Enrollment target
20
Study locations

NCT02293980: Active Phase 1 study of Renal Cell Carcinoma and Kidney Cancer, sponsored by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

NCT02293980 is a Phase 1 study of Renal Cell Carcinoma and Kidney Cancer that is active but no longer recruiting, run by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 110 participants, below the 242-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02293980, a Phase 1 study of Renal Cell Carcinoma and Kidney Cancer, is active but no longer recruiting, sponsored by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
110 participants
Enrollment target
20
Study locations

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.

Primary Outcome

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.

Conditions Studied

Renal Cell Carcinoma Kidney Cancer Clear Cell Renal Cell Carcinoma RCC ccRCC

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

FieldValue
Enrollment Target 110 participants
Start Date 2014-11-25
Est. Completion 2026-11-30
Phase Phase 1
Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

6 total trials

What the registry record for NCT02293980 still lists

NCT02293980 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 242-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (55% lower).

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.

NCT02293980 names 20 study sites across 14 states, led by Massachusetts, Tennessee, Ohio.

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.

What interventions are being tested in trial NCT02293980?

The interventions under investigation include: Nivolumab (DRUG), Cabozantinib (DRUG), MK-3795 (DRUG), Bezlutifan (DRUG).

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 6 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Renal Cell Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02293980's enrollment target sits among peer trials

110 50th of 121 higher than 71 of 121 other Renal Cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Renal Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02293980, the US trial registry maintained by the National Library of Medicine. NCT02293980 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.