RecruitingPhase 2NCT06757244

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

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


Sponsor

Hopital Foch

Enrollment

35 participants

Start Date

Feb 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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 objectives are : * To assess the safety and tolerability of mFOLFIRINOX + Dostarlimab + HD Vitamin D according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 by evaluating the Median Progression Free Survival (mPFS) in months, the Median Overall Survival (mOS) in months, the Median Duration of Response (mDOR) in months and Clinical benefit rate according to RECIST 1.1 (CBR) * To further evaluate the antitumor efficacy of mFOLFIRINOX + Dostarlimab + oral HD Vitamin D by evaluating the type, frequency, and severity of treatment-emergent adverse events (TEAEs); adverse events of special interest (AESIs); safety laboratory findings There are also exploratory objectives to better understand the pancreatic adenocarcinoma. Participants will be cared for in the digestive oncology department. A selection review will be carried out to check compliance with the study eligibility criteria. Patients included in the study will be treated with 4 cycles of induction therapy. Each cycle lasts 6weeks and includes chemotherapy such as mFolfirinox D1,D15 and D29, combined with dostarlimab 500 mg every 3 weeks and daily oral vitamin D3. At the end of the induction treatment period, maintenance treatment will be instituted with LV5FU chemotherapy combined with dostarlimab 1000 mg every 6 weeks and daily oral vitamine D3. Treatment will be maintained until progression or unacceptable toxicity. Throughout this period, patients will be monitored for their safety. Imaging examinations will also be carried out to monitor the progression of tumour disease.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of an immunotherapy drug (dostarlimab), Vitamin D3, and a chemotherapy regimen (mFOLFIRINOX) as a first-line treatment for people with advanced (stage IV) pancreatic cancer that has spread to other parts of the body. **You may be eligible if...** - You have been diagnosed with stage IV pancreatic adenocarcinoma (confirmed by biopsy) - You have not yet received treatment for stage IV disease - You are between 18 and 75 years old and are in reasonably good health - Your expected survival is more than 3 months - You have adequate blood, liver, and kidney function **You may NOT be eligible if...** - You have had prior chemotherapy for pancreatic cancer (including adjuvant/neoadjuvant) - You are pregnant or breastfeeding - You have an autoimmune disease requiring treatment, active HIV, hepatitis B, or hepatitis C - You have significant heart disease or severe nerve damage - You have a known enzyme deficiency (DPD) that affects how your body processes certain chemotherapy drugs - You have severe liver disease (cirrhosis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDostarlimab

Intra-venous (i.v) dostarlimab: day1 - d21: 500mg IV q3Weeks (cycle 1 to cycle 4) then 1000 mg IV q6Weeks (from cycle 5 onwards)

DRUGVitamin D3 (Cholecalciferol)

Oral vitamin D3 8000 IU/d for 14 days, then 4000IU/d

DRUGmFOLFIRINOX Treatment Regimen

mFOLFIRINOX d1, d15, d29 cycle 1 to cycle 4 is administered as follow: oxaliplatin 85 mg/m2 on day1, IV infusion over 2 h, immediately followed by folinic acid 400 mg/m2 or calcium levofolinate 200 mg/m2 given as a 2-h IV infusion, with the addition of irinotecan 180 mg/m2 as per dose-level given as a 90-min intravenous infusion through a Y-connector immediately followed by 5- fluorouracil 2400 mg/m2 over 46 h continuous infusion.

DRUGLV5FU2

folinic acid 400 mg/m2 Or calcium levofolinate 200 mg/m2 2-h IV infusion 5- fluoro-uracil 2400 mg/m2 Over 46 h continuous infusion. From cycle 5 onwards, D1=D43


Locations(5)

Marseille CRLCC

Marseille, France

CHU Hôtel Dieu

Nantes, France

Hôpital Européen Georges Pompidou

Paris, France

Hôpital Saint Antoine

Paris, France

Hôpital Foch

Suresnes, France

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NCT06757244


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