This clinical trial is focused on studying a type of cancer called pancreatic ductal adenocarcinoma, which can be locally advanced or has spread to other parts of the body. The study is testing a treatment approach that includes a medication known as OSE2101 (also referred to by its code name, OSE2101) combined with a chemotherapy regimen called FOLFIRI, or using FOLFIRI alone. FOLFIRI is a combination of chemotherapy drugs, including fluorouracil, irinotecan, and levoleucovorin. The purpose of the study is to evaluate the effectiveness of these treatments in maintaining the health of patients who have already undergone initial treatment with another chemotherapy regimen called FOLFIRINOX.

Participants in the study will receive either the combination of OSE2101 and FOLFIRI or FOLFIRI alone. The study will monitor the participants over a period to see how well they respond to the treatment and how long they live without the cancer getting worse. The study will also look at the side effects of the treatments and how they affect the participants’ quality of life. Some participants may receive a placebo as part of the study to help compare the effects of the actual treatments.

The trial is designed to help researchers understand if the combination of OSE2101 and FOLFIRI is more effective than FOLFIRI alone in treating this type of cancer. The study will involve regular check-ups and assessments, including imaging tests like CT scans, to track the progress of the disease and the impact of the treatment. The results of this study could provide valuable information for future treatment options for patients with pancreatic ductal adenocarcinoma.