Journal of Clinical Trials
Open Access

Abstract

DOVIPA, a phase II study evaluating efficacy and safety of DOstarlimab® and oral VItamin D3 with folinic acid, 5FU, Irinotecan plus oxalipaltin (mFOLFIRINOX) in non pretreated metastatic PAncreatic Cancer.

Asmahane Benmaziane*, Dahna Coupez, Nassiba Heba, Fanny Foubert, Jean Emmanuel Mitry, Baptiste Porte, Julien Taïeb, Isabelle Trouilloud, Angélique Vienot, Tassadit Ben belkacem, Jaafar Bennouna

Background: Our phase 2 trial evaluating a new combination of mFOLFIRINOX plus dostarlimab and oral vitamin D3 is justified by the high unmet need in metastatic pancreatic cancer. There is a need to find more effective combined anticancer therapy for patients with metastatic pancreatic cancer. There is also a need to incorporate a high level of translational research to better understand the mechanism of action of dostarlimab with oral vitamin D3. Pancreatic adenocarcinoma is known as a specific model for translational research in oncology because of the multiple mechanisms of resistance for chemotherapy and immunotherapy.

Methods: Our hypothesis is that the innovative regimen mFOLFIRINOX+Dostarlimab+oral vitamin D3 will be sufficiently effective to improve antitumor response in patients in with non-pre-treated metastatic pancreatic Cancer. Our trial will be a prospective, multi-centric, non-randomised, open-label, safety-run in, phase 2 study with 35 patients suffering from metastatic pancreatic cancer. Patients are being followed up in the gastroenterology or oncology departments of seven French hospitals.

Discussion: The DOVIPA study investigates a novel triplet regimen combining chemotherapy, immunotherapy, and a stromal modulator in first-line treatment of metastatic pancreatic cancer. The rationale for integrating dostarlimab and vitamin D3 with mFOLFIRINOX is supported by emerging data suggesting their potential synergistic effects. Vitamin D3, through its anti-fibrotic and immunomodulatory properties, may enhance chemotherapy delivery and immune infiltration by modifying the tumor microenvironment. Dostarlimab, a PD-1 inhibitor, is expected to counteract immune escape mechanisms and restore T-cell–mediated cytotoxicity. If the study confirms the efficacy and safety of this combination, it may open new therapeutic avenues and justify further evaluation in randomized controlled trials. Moreover, the translational component of the study may help identify predictive biomarkers of response or resistance, paving the way toward more personalized strategies in this highly lethal disease.

Trial Registration: NCT06757244

Published Date: 2025-08-27; Received Date: 2025-07-24