Pembrolizumab, Olaparib, Recurrent/Advanced Gastric and Gastro-esophageal Junction(GEJ) Cancer

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorYonsei University

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

Qualifiers

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

Treatments tested in this trial

  • olaparib+pembrolizumab+paclitaxel

Treatment groups

71 Participants
are divided into 1 treatment group

Sponsors and collaborators