REVOLUTION: Trial to Evaluate Immunotherapy Combinations with Chemotherapy for the Treatment of Patients with Previously Untreated Metastatic Pancreatic Adenocarcinoma

This is a phase 1 study that enrolls subjects with metastatic pancreatic adenocarcinoma. The purpose of this study is to learn about the safety and efficacy of a combination of 4 study drugs: ipilimumab (ipi), nab-paclitaxel (nP), gemcitabine (gem), and hydroxychloroquine (HCQ).

This is an open-label, non-randomized, exploratory platform trial designed to assess the safety and antitumor activity of immunotherapy, in combination with standard of care chemotherapy, in participants with mPDAC who have not received prior therapy. Where supportive mechanistic data are available, immunotherapy may also be combined with other treatment modalities (eg, radiation). Each cohort of this platform trial will test a different immunotherapy combination and consist of up to 2 stages: an initial stage (Stage 1) to evaluate safety, biomarkers, and/or clinical activity of the combination and an expanded cohort (Stage 2), when warranted, based on the safety, clinical activity, and/or biomarker results from Stage 1.