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Study on Dostarlimab, Vitamin D3, and Drug Combination for Untreated Metastatic Pancreatic Cancer Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying metastatic pancreatic cancer, which is a type of cancer that has spread from the pancreas to other parts of the body. The study is testing a combination of treatments to see how effective they are in treating this disease. The treatments being tested include Dostarlimab, an immunotherapy drug that helps the immune system fight cancer cells, and Vitamin D3, which is being used in high doses. These are combined with a chemotherapy regimen known as mFOLFIRINOX, which includes several drugs: Folinic Acid (also known as leucovorin), 5-Fluorouracil (5FU), Irinotecan, and Oxaliplatin. These drugs work together to stop the growth of cancer cells.

The purpose of the study is to evaluate the effectiveness and safety of this combination of treatments in patients who have not received prior treatment for their metastatic pancreatic cancer. Participants in the study will receive these treatments over a period of time, and their response to the treatment will be closely monitored. The study aims to understand how well the cancer responds to the treatment and to assess any side effects that may occur.

Throughout the study, participants will receive regular infusions of the medications, and their health will be monitored by healthcare professionals. The study will help determine if this combination of treatments can improve outcomes for patients with metastatic pancreatic cancer. The results of this study could provide valuable information for future treatment options for this challenging disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initiation of treatment

    Upon joining the study, the treatment begins with the administration of dostarlimab. This medication is given as a 500 mg solution for infusion. The infusion is administered intravenously, which means it is delivered directly into the bloodstream through a vein.

    The treatment also includes oxaliplatin, provided as a 5 mg/ml concentrate for infusion. This is also administered intravenously.

  2. Step 2

    Oral medication

    In addition to the infusions, colecalciferol (Vitamin D3) is taken orally. This is provided as a 10,000 UI/ml solution in the form of drops.

  3. Step 3

    Combination therapy

    The treatment regimen includes irinotecan hydrochloride trihydrate, which is a 20 mg/ml solution for infusion. This is administered intravenously.

    Additionally, folinic acid is given as a 10 mg/ml solution for injection or infusion, also administered intravenously.

  4. Step 4

    Chemotherapy

    The treatment plan includes fluorouracil, provided as a 50 mg/ml concentrate for infusion. This is administered intravenously.

  5. Step 5

    Monitoring and evaluation

    Throughout the trial, the response to the treatment is monitored. The primary goal is to assess the Objective Response Rate (ORR), which measures the proportion of patients with a reduction in tumor size.

    Safety and tolerability of the treatment are evaluated according to established criteria for adverse events.

Who can join the trial?

19 criteria

  • Must have a confirmed diagnosis of **Stage IV adenocarcinoma of the pancreas**, which means the cancer has spread to other parts of the body.
  • If there is a history of **hepatitis C (HCV) infection**, the viral load must be undetectable at the time of screening.
  • No active infection or serious infection in the past 30 days.
  • Must be able to understand and willing to sign a consent form before any study procedures.
  • Must be affiliated with a social security system.
  • No previous treatment for Stage IV pancreatic adenocarcinoma is allowed.
  • Must have an **ECOG performance status** of 0 to 1, which indicates the ability to carry out daily activities.
  • Age must be between 18 and 75 years.
  • Must have a measurable disease as per specific guidelines used to evaluate tumors.
  • Must have accessible tumor tissue available for a fresh biopsy.
  • Expected to live for more than 3 months.
  • Men and women who can have children must agree to use effective birth control methods. Women must not be pregnant or breastfeeding and must have a negative pregnancy test before starting the study. Men must use a condom with spermicide and avoid donating sperm during the study and for 120 days after the last dose of the study drug.
  • Must have certain laboratory values within specific limits, including:
    • **Platelet count** of at least 100,000 cells/mm3
    • **Absolute neutrophil count (ANC)** of at least 1,500 cells/mm3
    • **Hemoglobin** level of at least 9 g/dL
    • **Liver function** tests within specific limits
    • **Kidney function** with a creatinine clearance of at least 50 mL/min
    • For those not on warfarin, certain blood clotting tests must be within limits. Those on warfarin can participate if their dose is stable and within therapeutic range.
    • **Uracilemia** level must be less than 16 ng/ml

Who cannot join the trial?

9 criteria

  • Patients who have already received treatment for their pancreatic cancer cannot participate.
  • Patients with other serious health conditions that might interfere with the study treatment are not eligible.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients with a history of allergic reactions to similar drugs used in the study are excluded.
  • Patients who are unable to follow the study procedures or attend the required visits are not eligible.
  • Patients with certain infections, like HIV or hepatitis, are not allowed to participate.
  • Patients with a history of another type of cancer within the last 5 years, except for some skin cancers, are excluded.
  • Patients who have had a major surgery within the last 4 weeks cannot join the study.
  • Patients who are currently participating in another clinical trial are not eligible.
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Investigated drugs

  • Dostarlimab

    is a medication used in this trial to help the immune system recognize and attack cancer cells. It is a type of immunotherapy that targets specific proteins on cancer cells, potentially slowing down or stopping their growth.

  • Vitamin D3

    is included in the trial to support overall health and potentially enhance the effectiveness of cancer treatment. It is a vitamin that helps maintain bone health and may have additional benefits in cancer therapy.

  • Folinic Acid

    is used in combination with other chemotherapy drugs to enhance their effectiveness. It helps protect healthy cells and boosts the cancer-fighting effects of the treatment.

  • 5-Fluorouracil (5FU)

    is a chemotherapy drug that works by interfering with the DNA and RNA of cancer cells, preventing them from growing and dividing. It is a common treatment for various types of cancer.

  • Irinotecan

    is another chemotherapy drug used in this trial. It works by inhibiting an enzyme needed for cancer cell division, thereby slowing or stopping the growth of cancer cells.

  • Oxaliplatin

    is a chemotherapy medication that damages the DNA of cancer cells, leading to cell death. It is often used in combination with other drugs to treat different types of cancer.

What is already known about the treatment

  • Dostarlimab

    Dostarlimab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic pancreatic cancer. It is a monoclonal antibody that works by blocking a specific protein on cancer cells, helping the immune system to recognize and attack these cells. This medication is classified as an immune checkpoint inhibitor and is being evaluated for its potential to improve antitumor responses when used in combination with other treatments.

  • Vitamin D3

    Vitamin D3 is taken orally and is being investigated in clinical trials for its role in enhancing the treatment of metastatic pancreatic cancer. It is a form of vitamin D that helps regulate calcium and phosphate in the body, but in this context, it is being studied for its potential to support cancer treatment. Vitamin D3 is classified as a vitamin supplement and is being tested for its ability to improve the effectiveness of chemotherapy when used alongside other medications.

  • Folinic Acid

    Folinic acid is administered intravenously and is used in combination with other drugs to treat metastatic pancreatic cancer. It enhances the effects of chemotherapy drugs by stabilizing the binding of these drugs to cancer cells, thereby increasing their effectiveness. Folinic acid is classified as a chemoprotective agent and is an important component of combination chemotherapy regimens.

  • 5-Fluorouracil (5FU)

    5-Fluorouracil is given intravenously and is a well-established chemotherapy drug used in the treatment of various cancers, including metastatic pancreatic cancer. It works by interfering with the DNA synthesis of cancer cells, preventing their growth and division. This medication is classified as an antimetabolite and is a key part of combination chemotherapy protocols.

  • Irinotecan

    Irinotecan is administered intravenously and is used in the treatment of metastatic pancreatic cancer as part of combination chemotherapy. It works by inhibiting an enzyme necessary for DNA replication in cancer cells, leading to cell death. Irinotecan is classified as a topoisomerase inhibitor and is used to enhance the effectiveness of other chemotherapy drugs.

  • Oxaliplatin

    Oxaliplatin is given intravenously and is used in combination with other drugs to treat metastatic pancreatic cancer. It works by forming cross-links in DNA, which prevents cancer cells from dividing and growing. Oxaliplatin is classified as a platinum-based chemotherapy drug and is an integral part of combination chemotherapy regimens.

Investigated diseases

Metastatic Pancreatic Cancer – This is a type of cancer that begins in the pancreas and spreads to other parts of the body. The pancreas is an organ located behind the stomach that plays a role in digestion and blood sugar regulation. In metastatic pancreatic cancer, cancer cells break away from the original tumor and travel through the bloodstream or lymphatic system to form new tumors in other organs. This disease often progresses rapidly, with symptoms that may include abdominal pain, weight loss, and jaundice. As the cancer spreads, it can affect the function of the organs it invades, leading to a variety of complications. The progression of the disease can vary depending on the location and extent of the metastasis.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510004-49-00Protocol code2023_0111Estimated enrolment35 patientsSponsorHospital Foch

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).