Study of Zimberelimab and Quemliclustat with Chemotherapy for Treating Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

What this Trial Is About

Researchers are evaluating the combination of zimberelimab and quemliclustat with chemotherapy mFOLFIRINOX for treating patients with borderline resectable or locally advanced pancreatic adenocarcinoma. This phase III study aims to assess the safety, tolerability, and treatment effects including resection rates and progression-free survival. Immunotherapy with monoclonal antibodies like zimberelimab may help the immune system fight cancer, while quemliclustat blocks adenosine to potentially enhance immune response against the tumor. Chemotherapy drugs work by stopping cancer cell growth and spread, and this combination may improve outcomes compared to chemotherapy alone. Participants receive intravenous zimberelimab, quemliclustat, oxaliplatin, leucovorin calcium, and irinotecan as part of the treatment. Those with borderline resectable pancreatic cancer will have tissue samples collected, while patients with locally advanced disease will undergo core biopsies. Blood samples and CT scans are taken throughout the trial to monitor the disease and treatment effects. The study includes primary objectives such as evaluating adverse events, resection rates, progression-free survival, and pancreatic fistula development, along with secondary and exploratory goals related to tumor response and biological markers. During the study, participants are closely monitored with imaging, blood tests, and biopsies to evaluate treatment response and safety. The study measures outcomes like CA 19-9 tumor marker changes, objective response rate, pathologic complete response, and overall survival up to two years. Safety is assessed up to 90 days after the last treatment dose. The trial duration and follow-up periods are designed to provide detailed information on how this combination therapy affects pancreatic cancer progression and patient outcomes.

Zimberelimab and Quemliclustat in Combination With Chemotherapy for the Treatment of Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma