Actively Recruiting
Pembrolizumab and Olaparib Treatment for Relapsed or Refractory Peripheral T-Cell Lymphoma
Led by National Cancer Centre, Singapore · Updated on 2025-09-05
24
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
Sponsors
N
National Cancer Centre, Singapore
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pembrolizumab and Olaparib Treatment for Relapsed or Refractory Peripheral T-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 21 years or older with confirmed diagnosis of peripheral T-cell lymphoma (various subtypes).
- Male participants must agree to use contraception during treatment and for 180 days after last dose and avoid sperm donation during this time.
- Female participants must not be pregnant or breastfeeding and either not of childbearing potential or agree to contraception during treatment and for 180 days (Olaparib) or 120 days (Pembrolizumab) after last dose.
- Participants must have progressed on at least one prior systemic anti-cancer therapy, including anti-PD-1/L1 agents, with disease progression confirmed by Cheson criteria.
- Provide written informed consent.
- Have measurable disease based on Cheson criteria, including lesions in previously irradiated areas if progression occurred.
- Provide archival or newly obtained tumor tissue sample.
- Have ECOG performance status of 0 to 1 within 7 days prior to first dose.
- Have adequate organ function as defined by specific blood and liver function parameters within 10 days prior to treatment.
- Hepatitis B and C screening requirements are met with appropriate management.
- Have a life expectancy of at least 3 months.
You will not qualify if you...
- Female participants of childbearing potential with positive pregnancy test within 72 hours before treatment.
- Received systemic investigational agents or investigational devices within 4 weeks prior to treatment.
- Received radiotherapy within 2 weeks before treatment or have radiation-related toxicities needing corticosteroids, except limited palliative radiotherapy.
- Received live or live-attenuated vaccines within 30 days before treatment.
- Diagnosed with immunodeficiency or on high-dose systemic steroids or immunosuppressive therapy within 7 days before treatment.
- Have progressing additional malignancies requiring active treatment within past 3 years, except certain skin cancers and carcinoma in situ.
- Have active CNS metastases or carcinomatous meningitis, unless stable and off steroids.
- History of severe allergic reaction to pembrolizumab or its components.
- Active autoimmune disease requiring systemic treatment in past 2 years, except replacement therapies.
- History or current pneumonitis or interstitial lung disease needing steroids.
- Active infection needing systemic therapy.
- Known HIV infection.
- Concurrent active Hepatitis B or C infection.
- Not recovered from major surgery or have ongoing surgical complications.
- Conditions or circumstances interfering with study participation or safety as judged by investigator.
- Known psychiatric or substance abuse disorders interfering with trial cooperation.
- Pregnant, breastfeeding, or expecting to conceive or father children during study and 180 days after last treatment.
- History of allogenic tissue or solid organ transplant.
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Trial Site Locations
Total: 1 location
1
National Cancer Centre, Singapore
Singapore, Singapore, 168583
Actively Recruiting
Research Team
S
Soon Thye LIM, MBBS, MRCP, Grad Dip (HM)
CONTACT
J
Jason YS Chan, MBBS, MRCP, MMed, FAMS, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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