Phase II Study of Dostarlimab and Oral Vitamin D3 Combined with mFOLFIRINOX Chemotherapy for Untreated Metastatic Pancreatic Adenocarcinoma in Adults Aged 18 to 75

What this Trial Is About

Researchers are studying the antitumor response of a combination treatment including mFOLFIRINOX chemotherapy, Dostarlimab, and oral high-dose vitamin D3 in adults with metastatic Stage IV pancreatic adenocarcinoma who have not received prior treatment. This Phase II trial focuses on patients with good performance status ECOG 0 or 1 and adequate organ function, assessing tumor response and safety measures over a 24-month period. Participants will receive an induction therapy of four 6-week cycles combining mFOLFIRINOX chemotherapy administered on days 1, 15, and 29, along with Dostarlimab 500 mg intravenously every 3 weeks and daily oral vitamin D3 initially at 8000 IU for 14 days then 4000 IU daily. After induction, maintenance treatment involves LV5FU chemotherapy with Dostarlimab 1000 mg every 6 weeks and continued daily vitamin D3 until disease progression or unacceptable side effects occur. Throughout the study, patients will have regular safety monitoring including laboratory tests and imaging scans to evaluate tumor progression. Researchers will measure outcomes such as objective response rate by RECIST 1.1 criteria, adverse event incidence, progression-free and overall survival, and clinical benefit rate. Treatment effects and safety will be assessed up to 24 months, with ongoing follow-up during and after therapy.

DOVIPA, a Study Evaluating Efficacy and Safety of DOstarlimab and VItamin D3 With mFOLFIRINOX in PAncreatic Cancer