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

The goal of this clinical trial is to estimate the antitumor response of mFOLFIRINOX + Dostarlimab + oral HD vitamin D3 in patients with non-pretreated histologically confirmed metastatic Stage IV adenocarcinoma of the pancreas. The patients must have an Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) 0 or 1 and adequate organ functions. The main objective of the study will be assessed by estimating Objective response rate (ORR) according to Response Evaluation Criteria version 1.1 (RECIST 1.1) in patients with pancreatic adenocarcinoma and measurable disease. The Secondary

Trial Details

NCT ID
NCT06757244
Phase
PHASE2
Sponsor
Hopital Foch
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • Dostarlimab
  • Vitamin D3 (Cholecalciferol)
  • mFOLFIRINOX Treatment Regimen
  • LV5FU2
Locations (sample)
  • Marseille, France|43.29695,5.38107
  • Nantes, France|47.21725,-1.55336
  • Paris, France|48.85341,2.3488
  • Paris, France|48.85341,2.3488
  • Suresnes, France|48.87143,2.22929

Key Eligibility Criteria

  • Histologically confirmed metastatic Stage IV adenocarcinoma of the pancreas
  • No prior treatment for stage IV pancreatic adenocarcinoma (prior adjuvant or neoadjuvant treatment is not allowed)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
  • Male and female patients 18 - 75 years

For full eligibility, visit ClinicalTrials.gov.

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