Pembrolizumab and Olaparib Treatment for Relapsed or Refractory Peripheral T-Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-99
SponsorNational Cancer Centre, Singapore
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Male/female participants who are at least 21 years of age on the day of signing informed consent with histologically or cytologically-confirmed diagnosis of peripheral T-cell lymphoma (PTCL), including angioimmunoblastic T-cell lymphoma (AITL), peripheral T-cell lymphoma of T-follicular helper cell derivation (PTCL-TFH), anaplastic large cell lymphoma (ALCL), NK/T-cell lymphoma (NKTCL), gamma-delta T cell lymphoma (GDTL), enteropathy associated T-cell lymphoma (EATL), monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), subcutaneous panniculitis like T-cell lymphoma, and PTCL, not otherwise specified (PTCL-NOS) will be enrolled in this study.
A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies: a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least the time needed to eliminate the study intervention (180 days for Olaparib; 120 days for pembrolizumab) after the last dose of study treatment.
Has received at least 2 doses of an approved anti-PD-1/L1 mAb.
Has demonstrated disease progression after anti-PD-1/L1 as defined by Cheson response criteria. The initial evidence of PD is to be confirmed by a second assessment no less than 4 weeks from the date of the first documented disease progression, in the absence of rapid clinical progression (as defined in 4.c).
Disqualifiers
A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Has received prior systemic investigational agents within 4 weeks (or shorter interval for kinase inhibitors or other short half-life drugs, per investigator discretion) or has used an investigational device within 4 weeks prior to treatment.
Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1-week washout, is permitted.
Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
Trial design
Design model
Single group
Treatments tested in this trial
Pembrolizumab IV infusion Q3W, with daily oral Olaparib.
DrugPembrolizumab IV infusion 200 mg Q3W, with daily oral Olaparib 300mg BID, over a 3-week cycle.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Study TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rates of treatment with Pembrolizumab plus Olaparib based on Cheson response criteria assessed by independent central review
The proportion of subjects in the analysis population who have complete response (CR) or partial response (PR).
Time frame
Up to 5 years.Secondary outcomes
1
Overall survival (OS).
The time from the first day of study treatment to the time of death.
Time frame
Up to 5 years.2
Progression-free survival (PFS).
The time from the first day of study treatment to the first documented disease progression, or death due to any cause, whichever occurs first.
Time frame
Up to 5 years.3
Safety analysis based on subjects who experienced toxicities as defined by CTCAE criteria..
AEs graded using CTCAE (version 5.0).
Time frame
Up to 5 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National Cancer Centre, Singapore
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
National Medical Research Council (NMRC), Singapore
Collaborator
Source ClinicalTrials.gov