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.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510004-49-00

Acronym

2023_0111

Enrollment

Registered

2024-08-01

Start date

2025-02-18

Completion date

Unknown

Last updated

2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non pretreated metastatic PAncreatic Cancer

Brief summary

The primary endpoint of this study is the Objective Response Rate (ORR).

Detailed description

1. To assess the safety and tolerability of mFOLFIRINOX + dostarlimab + HD vitamin D3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, 2. To evaluate the antitumor efficacy of mFOLFIRINOX + dostarlimab + HD Vitamin D3.

Interventions

DRUGZYMAD 10 000 UI/ml

DRUGsolution buvable en gouttes

DRUGOxaliplatin medac 5 mg/ml concentrate for solution for infusion

DRUG5-Fluorouracil Sandoz 50 mg/ml koncentrátum oldatos infúzióhoz

DRUGJEMPERLI 500 mg concentrate for solution for infusion

DRUGIRINOTECAN MEDAC 20 mg/ml

DRUGsolution à diluer pour perfusion

DRUGFolinic acid (as calcium folinate) 10 mg/ml solution for injection/infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study is the Objective Response Rate (ORR).	—

Secondary

Measure	Time frame
1. To assess the safety and tolerability of mFOLFIRINOX + dostarlimab + HD vitamin D3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, 2. To evaluate the antitumor efficacy of mFOLFIRINOX + dostarlimab + HD Vitamin D3.	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026