Pembrolizumab and Olaparib Treatment for Relapsed or Refractory Peripheral T-Cell Lymphoma

The goal of this clinical trial is to evaluate the efficacy and safety of Pembrolizumab in combination with Olaparib in participants with relapsed/refractory Peripheral T-cell Lymphoma (PTCL). The study mainly aims to evaluate: * objective response rate (ORR) as per Cheson response criteria assessed by the independent central review * overall survival and progression-free survival * adverse events by CTCAE version 5.0 The administration of Pembrolizumab and Olaparib to participants will occur on Day 1 of each 3-week dosing cycle and will continue until disease progression or unacceptable toxicity, up to 35 cycles. Treatment with Olaparib will proceed continuously from Day 1 of Cycle 1, in 3-week dosing cycles in parallel with Pembrolizumab, up to 35 cycles, unless specific withdrawal/discontinuation criteria are met. After the end of treatment, each subject will be followed for 30 days for adverse event (AE) monitoring (serious AEs \[SAEs\] will be collected for 90 days after the end of treatment or 30 days after the end of treatment if the subject initiates new anticancer therapy, whichever is earlier).

NCT Number	NCT06160843
Lead Sponsor	National Cancer Centre, Singapore Collaborators: Merck Sharp & Dohme LLC, National Medical Research Council (NMRC), Singapore
Conditions	Relapsed Peripheral T-Cell Lymphoma, Refractory Peripheral T-Cell Lymphoma
Enrollment	24 participants
Start Date	2024-07-01
Primary Completion	2028-01 (estimated)
Study Completion	2028-01 (estimated)
Updated on ClinicalTrials.gov	2025-09-05