A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma (MK-3795-001)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) trials in the USA
Other trials for the same condition
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