Actively Recruiting
DOVIPA Phase II Study Evaluating Dostarlimab and Oral Vitamin D3 with mFOLFIRINOX in Untreated Metastatic Pancreatic Cancer
Led by Hopital Foch · Updated on 2025-03-18
35
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hopital Foch
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Male and female patients aged 18 to 75 years
- Measurable disease per RECIST 1.1 guidelines
- Accessible tumor tissue available for fresh biopsy
- Expected survival greater than 3 months
- Use of effective contraception for men and women of child-bearing potential
- Adequate hematologic, hepatic, and renal function within 1 week prior to randomization
- Undetectable HCV viral load if history of hepatitis C
- No active infection or serious infection within 30 days prior to enrollment
- Ability to understand and sign informed consent
- Affiliated to 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 injury 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 medical conditions excluding participation
- DPD deficiency or UGT1A1 homozygous 7/7 genotype
- Prior allogeneic stem cell or organ transplantation
- Immunodeficiency or chronic systemic steroid therapy above 10 mg prednisone equivalent
- Recent systemic steroid therapy or immunosuppressive medication
- Live vaccine within 30 days before treatment
- History or positive test for HIV
- Positive HBV infection markers
- Active autoimmune disease requiring recent systemic treatment
- History or current pneumonitis or interstitial lung disease
- Active infection requiring systemic therapy
- Severe allergic reactions to antibodies or study drugs
- Peripheral neuropathy with functional impairment prior to treatment
- Concomitant use of St John's Wort or related compounds
- Recent treatment with certain antiviral drugs affecting fluorouracil
- Diseases causing hypercalcemia or hypercalciuria
- Being deprived of liberty or under guardianship
- Pregnancy, breastfeeding, or unwillingness to use effective contraception during and 6 months after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or discontinuation
Participants receive a combination treatment of intravenous dostarlimab, oral vitamin D3, and mFOLFIRINOX chemotherapy regimen. Dostarlimab is given every 3 weeks for the first 4 cycles then every 6 weeks thereafter. Vitamin D3 is taken orally daily, starting with a higher dose for 14 days followed by a maintenance dose. mFOLFIRINOX is administered on days 1, 15, and 29 for the first 4 cycles, then LV5FU2 chemotherapy replaces mFOLFIRINOX from cycle 5 onwards on days 1, 15, and 29.
Visits on days 1, 15, and 29 of each cycle during the first 4 cycles; then visits every 6 weeks from cycle 5 onwards
Duration - Up to 24 months after last dose
Participants are monitored for safety and efficacy outcomes including adverse events and survival after treatment ends.
Periodic visits during follow-up as scheduled by the study
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
T
Tassadit Ben Belkacem
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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