TEDOPAM is a randomized (1.1.1) non-comparative phase II study. This study will assess the
efficacy and safety of OSE2101 alone or in combination with nivolumab followed by FOLFIRI
reintroduction, versus FOLFIRI as maintenance therapy in patients with advanced PDAC after
induction therapy with FOLFIRINOX.
Current standard of care for patients with advanced pancreatic ductal adenocarcinoma (PDAC)
is chemotherapy, preferential regimen being FOLFIRINOX (5FU, leucovorin, irinotecan, and
oxaliplatin) in fit patients (PS 0-1, bilirubin < 1.5 ULN). The question of how and when the
FOLFIRINOX regimen and doses can be deescalated after a period of disease control (i.e.
maintenance therapy) remains unanswered. In routine practice, oxaliplatin is usually stopped
after 6-8 cycles due to limiting neuropathy, and the fluoropyrimidine is continued, either
alone or, more frequently, in combination with irinotecan (FOLFIRI regimen), until disease
Immune therapies have opened new opportunities in cancer therapy. However, results of
immunotherapy in PDAC have been disappointing so far, with failure of checkpoint inhibitor
monotherapies (anti-CTLA4 and anti-PD-L1 monoclonal antibodies [mAb]) in progressive advanced
PDAC, while monovalent vaccines were demonstrated to be safe but with limited activity.
Pancreatic Ductal Adenocarcinoma, Locally Advanced Cancer, Metastatic Cancer
Clinical Study Identifier
GERCOR - Multidisciplinary Oncology Cooperative Group
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.