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A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of Oleclumab (MEDI9447) With or Without Durvalumab in Combination With Chemotherapy in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma
Participants in this trial will be randomised into one of 6 Arms of treatment, across two distinct cohorts. In cohort A, patients must have previously untreated metastatic pancreatic cancer (1st line metastatic disease). In Cohort B, patients with metastatic pancreatic cancer may have been previously treated with gemcitabine-based chemotherapy (without exposure to 5-FU, capecitabine, oxaliplatin) 2nd line metastatic disease. Two Arms across Cohort A and B (Arm A1 and Arm B1) will act as a comparators to the trial treatment, in which participants will either receive gemcitabine and nab-paclitaxel or mFOLFOX chemotherapy. In Arm A2 participants will receive gemcitabine and nab-paclitaxel plus MEDI9447, and in Arm A3 participants will also receive durvalumab on top of the Arm A2 treatment. In Arm B2 participants will receive mFOLXFOX chemotherapy plus MEDI9447, and in Arm B3 participants will also receive durvalumab on top of the Arm B2 treatment. All treatment will be given until disease progression.