Actively Recruiting
Evaluation of Paclitaxel Combined With Pembrolizumab and Olaparib as Second-Line Treatment for Recurrent/Advanced Gastric and Gastro-esophageal Junction Cancer
Led by Yonsei University · Updated on 2025-07-11
71
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment for recurrent or advanced gastric and gastro-esophageal junction cancer in patients who have previously experienced immune checkpoint inhibitor therapy. The study focuses on using pembrolizumab, a monoclonal antibody targeting the PD-1 receptor, olaparib, a PARP inhibitor, and paclitaxel, a commonly used chemotherapy drug. This is an open-label, single-arm, multi-center Phase Ib/II study aiming to assess the effectiveness of this combination as a second-line treatment. Participants will receive a combination of olaparib taken orally twice daily at doses between 100 and 200 mg, pembrolizumab administered intravenously every three weeks at 200 mg, and paclitaxel given intravenously weekly at 80 mg/m2. This treatment regimen is designed to build on previous therapies and evaluate the combined effects of these drugs in advanced cancer. The study does not include placebo or comparator groups. During the study, participants will undergo regular evaluations including assessments of disease progression every six weeks and monitoring for any dose-limiting toxicities within the first 21 days of treatment. Researchers will also evaluate overall response rates to the therapy. Monitoring includes physical exams, imaging, laboratory tests, and performance status evaluations. The total participation duration depends on treatment response and safety outcomes, with ongoing monitoring throughout the study period ending in May 2026.
CONDITIONS
Brief 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.
- Adequate organ function as defined by study criteria.
- Life expectancy of at least 3 months.
- Ability to swallow and retain oral medications.
- Failed first-line trastuzumab treatment for HER2 positive patients.
- Use of highly effective contraception if there is risk of conception.
- Left ventricular ejection fraction (LVEF) of 50% or higher.
You will not qualify if you...
- Positive urine pregnancy test within 72 hours prior to allocation for women of childbearing potential.
- Prior systemic anti-cancer therapy including investigational agents within 2 weeks before allocation.
- Radiotherapy within 2 weeks before study treatment start.
- Receipt of live vaccine within 30 days prior to first dose of study drug.
- Participation in another investigational study or use of investigational devices within 4 weeks prior to first dose.
- Diagnosis of immunodeficiency or use of high-dose systemic steroids or other immunosuppressive therapy within 7 days prior.
- Known additional malignancy requiring active treatment within past 5 years.
- Active central nervous system metastases or carcinomatous meningitis.
- Severe hypersensitivity to pembrolizumab, PARP inhibitors, or paclitaxel.
- Active autoimmune disease requiring systemic treatment in past 2 years.
- History or current pneumonitis requiring steroids.
- Active infection requiring systemic therapy.
- Known HIV infection.
- Active Hepatitis B or C infection.
- Active tuberculosis under treatment.
- Previous allogenic bone marrow, tissue, solid organ transplant, or double umbilical cord transplantation (dUCBT).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Continued until disease progression or unacceptable toxicity
Participants receive a combination of olaparib taken orally twice daily, pembrolizumab given intravenously every 3 weeks, and paclitaxel given intravenously weekly as second-line treatment for recurrent or advanced gastric and gastro-esophageal junction cancer.
Weekly visits for paclitaxel infusions and pembrolizumab infusions every 3 weeks
Trial Site Locations
Total: 1 location
1
Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
S
Sun Young Rha, MD. Ph.D
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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