Study of Pembrolizumab Combined With Decitabine and Pralatrexate in PTCL and CTCL
Status:
Not yet recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Owen A. O'Connor University of Virginia
Collaborators:
Merck Sharp & Dohme Corp. Otsuka Pharmaceutical Development & Commercialization, Inc. Samsung Medical Center University of Bologna