Actively Recruiting
DOVIPA, a Study Evaluating Efficacy and Safety of DOstarlimab and VItamin D3 With mFOLFIRINOX in PAncreatic Cancer
Led by Hopital Foch · Updated on 2025-03-18
35
Participants Needed
5
Research Sites
156 weeks
Total Duration
On this page
Sponsors
H
Hopital Foch
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DOVIPA, a Study Evaluating Efficacy and Safety of DOstarlimab and VItamin D3 With mFOLFIRINOX in PAncreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic Stage IV adenocarcinoma of the pancreas
- No prior treatment for stage IV pancreatic adenocarcinoma
- ECOG performance status 0 or 1
- Male or female aged 18 to 75 years
- Measurable disease by RECIST 1.1
- Accessible tumor tissue available for fresh biopsy
- Expected survival greater than 3 months
- Use of adequate contraception for men and women of child-bearing potential
- Adequate hematologic, hepatic, and renal function within 1 week prior to randomization
- History of hepatitis C allowed if viral load is undetectable
- No active or serious infection within the past 30 days
- Ability to understand and sign informed consent
- Affiliation with a social security regimen
You will not qualify if you...
- Endocrine or acinar pancreatic carcinoma
- Cirrhosis or unstable liver/biliary disease
- Major surgery or significant trauma within 28 days before treatment
- Known brain metastases or central nervous system tumors
- Prior anticancer treatment for pancreatic adenocarcinoma
- Known hypersensitivity to study treatment components
- Pregnancy or breastfeeding
- Clinically relevant coronary artery disease or recent myocardial infarction
- Previous malignancy within 5 years except certain skin or cervical cancers
- Central nervous system disease or peripheral neuropathy grade 1 or higher
- Significant diseases excluding study participation
- Deficiency in DPD enzyme or UGT1A1 homozygous 7/7
- Prior allogeneic stem cell or organ transplant
- Immunodeficiency or chronic systemic steroid therapy exceeding 10 mg prednisone daily
- Recent systemic steroid therapy or immunosuppressive medication
- Live vaccine within 30 days before study
- HIV positive
- Positive hepatitis B screening within 3 months before dosing
- Active autoimmune disease needing systemic treatment in past 2 years
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active infection needing systemic therapy
- Severe allergies or anaphylaxis to study drugs
- Peripheral neuropathy, bowel disease, or drug interactions contraindicating treatment
- Conditions causing hypercalcemia or hypercalciuria
- Being under guardianship or deprived of liberty
- Pregnancy, breastfeeding, or unwillingness to use contraception during and 6 months after treatment
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Marseille CRLCC
Marseille, France
Not Yet Recruiting
2
CHU Hôtel Dieu
Nantes, France
Not Yet Recruiting
3
Hôpital Européen Georges Pompidou
Paris, France
Not Yet Recruiting
4
Hôpital Saint Antoine
Paris, France
Not Yet Recruiting
5
Hôpital Foch
Suresnes, France, 92150
Actively Recruiting
Research Team
A
Asmahane BENMAZIANE TEILLET, Dr
CONTACT
T
Tassadit Ben Belkacem
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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