About this trial
Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD 1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). Olaparib is a potent PARP inhibitor (PARP1, 2, and 3) that is being developed as a monotherapy as well as for combination with chemotherapy, ionizing radiation, and other anti-cancer agents including novel agents and immunotherapy. Paclitaxel is widely used in breast, lung and gastric cancer with every 3-week or weekly cycle. Various targeted anticancer agents have been investigated with paclitaxel and combination with ramucirumab, a monoclonal anti-VEGFR2 antibody, was approved as a 2nd line treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provided written informed consent for treatment.
Age ≥ 19 years old
measurable or evaluable disease based on RECIST 1.1. Lesions
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 on time of patient's allocation.
Disqualifiers
A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation
Has received prior systemic anti-cancer therapy including investigational agents within 2 weeks prior to allocation.
Has received prior radiotherapy within 2 weeks of start of study treatment.
Has received a live vaccine within 30 days prior to the first dose of study drug.
Trial design
Single group
Treatments tested in this trial
olaparib+pembrolizumab+paclitaxel
Drugolaparib, 100\~200mg, PO, bid, continuous Pembrolizumab 200mg, IV, q 3 weeks Paclitaxel 80mg/m2 IV, Q weekly
Treatment groups
Trial outcomes
Primary outcomes
progression free survival
progression free survival
Dose Limiting Toxicity
Dose Limiting Toxicity
Secondary outcomes
overall response rate
overall response rate
Sponsors and contacts
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