A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma (MK-3795-001)
Public ClinicalTrials.gov record NCT02293980. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, Multiple-Dose, Dose-Escalation Trial of PT2385 Tablets, a HIF-2α Inhibitor, in Patients With Advanced Clear Cell Renal Cell Carcinoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02293980
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Industry
- Enrollment
- 110 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 25, 2014 (Actual)
- Primary completion
- Jan 31, 2017 (Actual)
- Completion
- Nov 30, 2026 (Estimated)
- Last update posted
- Jun 17, 2024
2014 – 2026
United States locations
- U.S. sites
- 25
- U.S. states
- 18
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | — |
| Yale School of Medicine | New Haven | Connecticut | 06510 | — |
| University of Miami - Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| Emory University Winship Cancer Institue | Atlanta | Georgia | 30322 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Indiana University Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| University of Maryland - Greenebaum Cancer Center | Baltimore | Maryland | 21201 | — |
| Massachusetts General Hospital - Cancer Center | Boston | Massachusetts | 02114 | — |
| Beth Israel Deconess Medical Center | Boston | Massachusetts | 02215 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Mount Sinai Heath System | New York | New York | 10019-1147 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| University of Pittsburg Medical Center | Pittsburgh | Pennsylvania | 15232 | — |
| The West Clinic | Germantown | Tennessee | 38138 | — |
| Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| Vanderbilt Medical Center | Nashville | Tennessee | 37232 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75239 | — |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | — |
| Swedish Cancer Institute | Seattle | Washington | 98104 | — |
| University of Washington | Seattle | Washington | 98109 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02293980, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 17, 2024 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02293980 live on ClinicalTrials.gov.