drugset / Trial / NCT04592211

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

NCT04592211

Phase 1/2 Recruiting 71 enrolled Yonsei University
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2021-10-01
Primary completion
2025-12-31
Completion
2026-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Olaparib Small molecule 100 mg Oral
Subject Olaparib Small molecule 200 mg Oral
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous

Indications