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

NCT06160843 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-09-05

No results posted yet for this study

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).

Conditions

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

Interventions

DRUG

Pembrolizumab IV infusion Q3W, with daily oral Olaparib.

Pembrolizumab IV infusion 200 mg Q3W, with daily oral Olaparib 300mg BID, over a 3-week cycle.

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • National Medical Research Council (NMRC), Singapore

    collaborator OTHER_GOV

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • Soon Thye LIM, MBBS, MRCP, Grad Dip (HM) · National Cancer Centre, Singapore

  • Jason YS Chan, MBBS, MRCP, MMed, FAMS, PhD · National Cancer Centre, Singapore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2028-01-31
Completion
2028-01-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06160843 on ClinicalTrials.gov