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

Sponsor
Yonsei University
Study ID
NCT04592211
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Gastric Cancer Stage IV

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 1, 2021
Status verified
Jul 2025
Primary completion
Dec 31, 2025
Completion
May 31, 2026

Study Design

Enrollment
71 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: olaparib+pembrolizumab+paclitaxel
    olaparib+pembrolizumab+paclitaxel

Primary Outcome Measure

progression free survival [ Time Frame: 6 weeks ]

Central Contacts