drugset / Trial / NCT03240211
Study of Pembrolizumab Combined With Decitabine and Pralatrexate in PTCL and CTCL
Phase 1
Active not recruiting
37 enrolled
University of Virginia
Merck Sharp & Dohme LLC · collabOtsuka Pharmaceutical Development & Commercialization, Inc. · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is an international, multicenter, multi-arm, phase Ib, model-based dose-escalation study. The primary objectives of the study in each arm is to determine the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), dose limiting toxicities (DLTs) and to evaluate the clinical efficacy at the MTD of various combinations of pembrolizumab, pralatrexate and decitabine.
Timeline
- Start
- 2022-02-02
- Primary completion
- 2025-07-24
- Completion
- 2026-05-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Decitabine | Small molecule | 10 mg/m2 | Intravenous |
| Subject | Decitabine | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Pralatrexate | Other / unclassified | 20 mg/m2 | Intravenous |
| Subject | Pralatrexate | Other / unclassified | 30 mg/m2 | Intravenous |