Study of Durvalumab and Rintatolimod Combination Therapy for Adults With Metastatic Pancreatic Ductal Adenocarcinoma

What this Trial Is About

Pancreatic ductal adenocarcinoma PDAC is a serious cancer expected to become the second leading cause of cancer-related death by 2030. This research is exploring a new treatment combination for adults with metastatic PDAC who have stable disease after chemotherapy. The study focuses on combining durvalumab, an anti-PD-L1 immune checkpoint inhibitor, with rintatolimod, a toll-like receptor 3 TLR-3 agonist, aiming to enhance the immune systems response against the tumor. Participants will receive intravenous infusions of rintatolimod twice weekly for 6 weeks, starting at 200mg and potentially increasing to 400mg. Durvalumab infusions of 1500mg begin in the second week and continue every 4 weeks for up to 48 weeks or until disease progression or unacceptable side effects occur. The study includes an initial safety phase followed by a phase II trial to assess the treatments clinical benefit and immune effects. During the study, patients will have regular infusions, blood tests, and some will have tumor biopsies before treatment and after 12 weeks. Researchers will monitor safety, immune response, disease progression, survival rates, and quality of life. The total participation can last up to one year, with close follow-up and assessments to understand the treatments impact and side effects.

Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy