Pembrolizumab and Olaparib Treatment for Relapsed or Refractory Peripheral T-Cell Lymphoma
Status:
Not yet recruiting
Trial end date:
2028-01-01
Target enrollment:
Participant gender:
Summary
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).
Phase:
Phase 2
Details
Lead Sponsor:
National Cancer Centre, Singapore
Collaborators:
Merck Sharp & Dohme LLC National Medical Research Council (NMRC), Singapore