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Tests treatment safety and results for Pancreas Neoplasms
Official title DOVIPA, a Study Evaluating Efficacy and Safety of DOstarlimab and VItamin D3 With mFOLFIRINOX in PAncreatic Cancer
ClinicalTrials.gov ID: NCT06757244
What this study is testing
What is Dostarlimab?
Dostarlimab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for pancreas neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
- Measurable disease determined using guidelines of Response Evaluation Criteria In Solid Tumors (RECIST version 1.1)
See the full eligibility criteria
Who can join
- 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
- Measurable disease determined using guidelines of Response Evaluation Criteria In Solid Tumors (RECIST version 1.1)
- Accessible tumor tissue available for fresh biopsy
- Expected survival \>3 months
- Men and women of child-bearing potential must agree to use adequate contraception. A female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions...
- Is not a woman of childbearing potential (WOCBP), or
- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), from the screening visit to at least 6 months after the last dose of study treatment, and agrees not to donate...
- Laboratory values ≤1 week prior to randomization must be Adequate hematologic values
- Platelet count ≥100,000 cells/mm3
- Absolute neutrophil count [ANC] ≥1,500 cells/mm3
- Hemoglobin ≥9 g/dL or ≥90 g/L) Adequate hepatic function
- Aspartate aminotransferase [AST/SGOT] ≤2.5x Upper Normal Limit [UNL] (≤5x UNL if liver metastases present)
- Alanine aminotransferase [ALT/SGPT] ≤ 2.5x Upper Normal Limit (≤5x UNL if liver metastases present)
- Bilirubin ≤1.5x UNL
- Serum albumin \> 3.0 g/dL Adequate renal function serum creatinine clearance CLcr ≥ 50 mL/min) (Cocroft-Gault Formula should be used for CrCl calculation) For participants not taking warfarin: INR \<1.5 or PT \<1.5 x...
- Patients with history of hepatitis C (HCV) infection are eligible if HCV viral load is undetectable at screening. HCV screening tests are not required unless there is a known history of HCV infection.
- No evidence of active infection and no serious infection within the past 30 days.
- Patient able to understand and willing to sign and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures
- Patient affiliated to a social security regimen Non-1. Endocrine or acinar pancreatic carcinoma
- Participant has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or...
- Major surgical procedure, significant traumatic injury within 28 days prior to study treatment start. Incompletely healed wounds or anticipation of the need for major surgical procedure during the course of the study
- Known cerebral metastases, central nervous system (CNS), or epidural tumor
- Prior anticancer treatment for adenocarcinoma of the pancreas including prior adjuvant or neoadjuvant treatment
- Known dose tivity reaction to any of the components of study treatments.
- Pregnancy (absence to be confirmed by β-hCG test) or breast-feeding period
- Clinically relevant coronary artery disease or history of myocardial infarction in the last 6 months, or high risk of uncontrolled arrhythmia (for men: QTc ≥450 msec, for women: QTc ≥470 msec). Inclusion of patients...
- Previous malignancy in the last 5 years except curative treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
- History or current evidence on physical examination of central nervous system disease or peripheral neuropathy ≥ grade 1 Common Toxicity Criteria for Adverse Events (CTCAE) v5.0.
- Any significant disease which, in the investigator's opinion, would exclude the patient from the study.
- Patient with a DPD deficiency or UGT1A1 homozygous 7/7; the test should be done for all patients before 5-FU administration, according to ANSM communication regarding recommendation about high risk of no testing DPD in...
- Has undergone prior allogeneic hematopoietic stem cell transplantation
- Has had an allogeneic tissue/solid organ transplant
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent)
- Participant has received systemic steroid therapy (\>10 mg daily prednisone or equivalent) within 7 days before the first dose of the study treatment or is receiving any other form of immunosuppressive medication...
- Participant has received a live vaccine within 30 days of planned start of study therapy. COVID-19 vaccines that do not contain live viruses are allowed. Note: mRNA and adenoviral-based COVID-19 vaccines are considered...
- History of or serology positive for HIV
- Patients who have documented presence of HBsAg [or HBcAb] at Screening or within 3 months prior to first dose of study intervention are excluded. HBV screening tests are not required unless there is a known history of...
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine...
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy
- Allergy: Participant cannot have history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies or fusion proteins, sensitivity to any of the study treatments or components thereof...
- patient has a peripheral sensitive neuropathy with functional impairment prior to first course (contra-indication use with Oxaliplatin)
- concomitant use with St John's Wort - Chronic inflammatory bowel disease and/or bowel obstruction (contra-indication with Irinotecan)
- patient which has been treated with brivudine, sorivudine or their chemically related analogues, which are potent inhibitors of the enzyme dihydropyrimidine dehydrogenase (DPD), which degrades fluorouracil. Fluorouracil...
- patient has diseases/conditions associated hypercalcaemia and / or hypercalciuria. - Calcium nephrolithiasis, nephrocalcinosis, D- hypervitaminosis
- Being deprived of liberty or under guardianship
- Potential participants who are pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and/or unwilling to use highly effective contraception for up to 6 months after the last dose of...
The study team makes the final eligibility decision.
Where it's taking place
- Marseille, France
- Nantes, France
- Paris, France
- Suresnes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Marseille, France; Nantes, France; Paris, France; Suresnes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.