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RECRUITINGPHASE1/PHASE2

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

An Open Label, Single-Arm, Multi-center Phase Ib/II Study to Evaluate the Efficacy of Paclitaxel in Combination With Pembrolizumab and Olaparib as a Second Line Treatment in Immune Checkpoint Inhibitor-experienced Recurrent/Advanced Gastric and Gastro-esophageal Junction(GEJ) Cancer.

NCT04592211•Yonsei University

View on ClinicalTrials.gov

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.

Detailed Description

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provided written informed consent for treatment.
•2. Age ≥ 19 years old
•3. measurable or evaluable disease based on RECIST 1.1. Lesions
•4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 on time of patient's allocation.
•5. Adequate organ function as defined by the following criteria:
•6. A life expectancy of at least 3 months
•7. Is able to swallow and retain orally administered medications
•8. Failed first-line trastuzumab treatment for HER2 positive patients
•9. Highly effective contraception for both male and female subjects if the risk of conception exists.
•10. Left ventricular ejection fraction (LVEF) ≥50%

Exclusion Criteria

•1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation
•2. Has received prior systemic anti-cancer therapy including investigational agents within 2 weeks prior to allocation.
•3. Has received prior radiotherapy within 2 weeks of start of study treatment.
•4. Has received a live vaccine within 30 days prior to the first dose of study drug.
•5. 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.
•6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
•7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.
•8. Has known active CNS metastases and/or carcinomatous meningitis.
•9. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients, PARP inhibitor and paclitaxel.
•10. Has active autoimmune disease that has required systemic treatment in the past 2 years
+6 more criteria

Locations (1)

Severance Hospital

Seoul, South Korea

Key Dates

Start Date

October 1, 2021

Primary Completion Date

December 31, 2025

Completion Date

May 31, 2026

Last Updated

July 11, 2025

Enrollment

ESTIMATED participants

Conditions

Gastric Cancer Stage IV

Interventions

olaparib+pembrolizumab+paclitaxel

DRUG

Contacts

Sun Young Rha, MD. Ph.D

CONTACT

82-2-2228-8053 rha7655@yuhs.ac

Systemic Application of Cadonilimab, LM-302, and S-1 Combined With Intraperitoneal Infusion of Paclitaxel for the Treatment of Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis

NCT06519591

Gastric Cancer Stage IVPeritoneal Metastases

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UNKNOWNPHASE2

Conversion Therapy of Sintilimab in Combination With Apatinib and Chemotherapy in Stage IV Gastric Cancer

NCT04267549

Gastric Cancer Stage IV

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Systemic Application of Cadonilimab, LM-302, and S-1 Combined With Intraperitoneal Infusion of Paclitaxel for the Treatment of Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis

Conversion Therapy of Sintilimab in Combination With Apatinib and Chemotherapy in Stage IV Gastric Cancer

Efficacy and Safety of Toripalimab Combined With Docetaxel or Nab-paclitaxel in Patients With Advanced Gastric Cancer

Maintenance Treatment With S-1 in Gastric Cancer Patients