RecruitingPhase 2NCT06160843

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

Sponsor

National Cancer Centre, Singapore

Enrollment

24 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Relapsed Peripheral T-Cell Lymphoma Refractory Peripheral T-Cell Lymphoma

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).

Eligibility

Min Age: 21 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer drugs — pembrolizumab (an immunotherapy) and olaparib (a PARP inhibitor) — in people whose rare T-cell blood cancer (peripheral T-cell lymphoma) has come back or stopped responding to treatment. **You may be eligible if...** - You are 21 years or older - You have been diagnosed with peripheral T-cell lymphoma (PTCL) or a related subtype (such as AITL, ALCL, NK/T-cell lymphoma, or others) - Your cancer has progressed after at least one prior treatment - You have measurable disease on scans - Your general health is good enough to function independently (ECOG score 0–1) - Your liver, kidneys, and blood counts are within acceptable ranges - You agree to use contraception during the study and for several months after **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have active brain metastases or serious autoimmune disease - You have a history of HIV, or active hepatitis B and C together - You have had a recent organ or tissue transplant - You received recent radiotherapy, a live vaccine, or other cancer therapy within the required washout period - You have severe lung disease or ongoing serious infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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