OncoMatch/Clinical Trials/NCT06160843
Pembrolizumab and Olaparib Treatment for Relapsed or Refractory Peripheral T-Cell Lymphoma
Is NCT06160843 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pembrolizumab IV infusion Q3W, with daily oral Olaparib. for relapsed peripheral t-cell lymphoma.
Treatment: Pembrolizumab IV infusion Q3W, with daily oral Olaparib. — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic anti-cancer therapy
Participants must have progressed on treatment with at least one prior systemic anti-cancer therapy including investigational agents. These may include an anti-PD-1/L1 mAb administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.
Cannot have received: systemic investigational agent
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.
Cannot have received: radiotherapy
Exception: Two weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1-week washout, is permitted.
Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
Lab requirements
Blood counts
absolute neutrophil count (anc)≥500/μl; platelets ≥25 000/μl; hemoglobin ≥8 g/dl
Kidney function
creatinine or measured or calculated creatinine clearance (gfr can also be used in place of creatinine or crcl) ≤1.5 × uln or ≥30 ml/min for participant with creatinine levels >1.5 × institutional uln
Liver function
total bilirubin ≤1.5 ×uln or direct bilirubin ≤uln for participants with total bilirubin levels >1.5 × uln; ast (sgot) and alt (sgpt) ≤2.5 × uln (≤5 × uln for participants with liver metastases)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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