Study of Paclitaxel with Pembrolizumab and Olaparib as Second-Line Treatment for Advanced Gastric and Gastro-esophageal Junction Cancer

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 IbII 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 mgm2. 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.

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