Actively Recruiting
Pembrolizumab, Olaparib, Recurrent/Advanced Gastric and Gastro-esophageal Junction(GEJ) Cancer
Led by Yonsei University · Updated on 2025-07-11
71
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pembrolizumab, Olaparib, Recurrent/Advanced Gastric and Gastro-esophageal Junction(GEJ) Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent for treatment.
- Age 19 years or older.
- Measurable or evaluable disease based on RECIST 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at allocation.
- Adequate organ function according to study definitions.
- Life expectancy of at least 3 months.
- Ability to swallow and retain oral medications.
- Failed first-line trastuzumab treatment if HER2 positive.
- Use of highly effective contraception if the risk of conception exists.
- Left ventricular ejection fraction (LVEF) of 50% or higher.
You will not qualify if you...
- Women of childbearing potential with a positive urine pregnancy test within 72 hours before allocation.
- Prior systemic anti-cancer therapy including investigational agents within 2 weeks before allocation.
- Prior radiotherapy within 2 weeks before starting study treatment.
- Receipt of a live vaccine within 30 days before the first study drug dose.
- Participation in another investigational study or use of investigational devices within 4 weeks before the first study drug dose.
- Diagnosis of immunodeficiency or use of chronic systemic steroid or other immunosuppressive therapy within 7 days before the first study drug dose.
- Known additional malignancy progressing or requiring treatment within past 5 years.
- Known active central nervous system metastases or carcinomatous meningitis.
- Severe hypersensitivity (grade 3 or higher) to pembrolizumab, PARP inhibitors, paclitaxel, or their excipients.
- Active autoimmune disease requiring systemic treatment in past 2 years.
- History of pneumonitis requiring steroids or current pneumonitis.
- Active infection requiring systemic therapy.
- Known history of HIV infection.
- Active Hepatitis B or C infection as defined by study criteria.
- Active tuberculosis under treatment.
- Previous allogenic bone marrow, tissue/solid organ transplant, or double umbilical cord transplantation.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
S
Sun Young Rha, MD. Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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