drugset / Trial / NCT02293980
A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma (MK-3795-001)
Phase 1
Active not recruiting
110 enrolled
Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2014-11-25
- Primary completion
- 2017-01-31
- Completion
- 2026-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MK-3795 | Unknown | 100 mg | Oral |
| Subject | MK-3795 | Unknown | 800 mg | Oral |
| Subject | MK-3795 | Unknown | 1800 mg | Oral |
| Background | Belzutifan | Small molecule | 120 mg | Oral |
| Background | Cabozantinib | Small molecule | 20 mg | Oral |
| Background | Cabozantinib | Small molecule | 60 mg | Oral |
| Background | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |