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OncoMatch/Clinical Trials/NCT04592211

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

Is NCT04592211 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies olaparib+pembrolizumab+paclitaxel for gastric cancer stage iv.

Phase 1/2RecruitingYonsei UniversityNCT04592211Data as of Jun 2026Location: South Korea

Treatment: olaparib+pembrolizumab+paclitaxelPembrolizumab 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.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

olaparib+pembrolizumab+paclitaxel

Cancer type

Gastric Cancer

Biomarker criteria

Allowed: HER2 (ERBB2) amplification

Failed first-line trastuzumab treatment for HER2 positive patients

Disease stage

Required: Stage IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≥ 19

Prior therapy

Min 1 prior line

Must have received: trastuzumab (trastuzumab) — first-line

Failed first-line trastuzumab treatment for HER2 positive patients

Cannot have received: systemic anti-cancer therapy

Has received prior systemic anti-cancer therapy including investigational agents within 2 weeks prior to allocation.

Cannot have received: radiotherapy

Has received prior radiotherapy within 2 weeks of start of study treatment.

Cannot have received: investigational agent (trastuzumab)

Is currently participating in or has participated in a study of an investigational agent including trastuzumab or has used an investigational device within 4 weeks prior to the first dose of study treatment.

Lab requirements

Cardiac function

left ventricular ejection fraction (lvef) ≥50%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT04592211 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior systemic anti-cancer therapy, radiotherapy, investigational agent disqualifies patients from enrollment.

What disease stage is eligible?

Stage IV is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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