Phase II Study of Pembrolizumab and Olaparib Combination Therapy in Metastatic Pancreatic Cancer Patients with High Tumor Mutation Burden or Mismatch Repair Deficiency

What this Trial Is About

This research aims to evaluate the combination of pembrolizumab and olaparib in patients with metastatic pancreatic adenocarcinoma who have a high tumor mutation burden or specific genetic markers like mismatch repair deficiency or microsatellite instability. This phase II, open-label, single-arm trial focuses on patients with advanced disease and looks to assess the effectiveness of this combined therapy. Participants will receive pembrolizumab as a 200 mg intravenous infusion every three weeks, along with oral olaparib at a dose of 300 mg twice daily for 21 days in each cycle. Treatment cycles repeat every three weeks. The study includes only one treatment group receiving this combination, with dosing starting on day one of each cycle. During the study, participants will be monitored regularly through imaging and various assessments including the Objective Response Rate over about two years. Safety and side effects will be tracked, along with measures of response duration, progression-free survival, overall survival, and quality of life using cancer-specific questionnaires every 9 to 12 weeks. The total duration of participation can last up to approximately two years with ongoing evaluations.

Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer