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Study on the Safety and Effectiveness of mFOLFIRINOX with or without BNT321 for Patients with Resected Pancreatic Cancer

Verified siteRegistered drugNo placebo
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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 the treatment of pancreatic ductal adenocarcinoma, a type of cancer that begins in the ducts of the pancreas. The study will evaluate the safety, tolerability, and effectiveness of a treatment regimen called mFOLFIRINOX, which is a combination of several chemotherapy drugs, with or without an additional drug known as BNT321. BNT321 is a type of protein called a monoclonal antibody that targets specific cancer cells. The trial is designed for patients who have had a surgical procedure to remove the cancer, known as a curative resection.

The purpose of the study is to determine if adding BNT321 to the standard mFOLFIRINOX treatment improves outcomes for patients. The study will be conducted in two phases. In the first phase, the focus will be on assessing the safety of BNT321 when used with mFOLFIRINOX and determining the appropriate dose for the second phase. The second phase will compare the effectiveness of mFOLFIRINOX with BNT321 against mFOLFIRINOX alone in preventing the return of cancer after surgery.

Participants in the trial will receive the treatments through intravenous infusion, which means the medication will be delivered directly into the bloodstream through a vein. The study will monitor patients for any side effects and measure how long they remain free of cancer after treatment. The trial aims to provide valuable information on whether the addition of BNT321 can offer better protection against the recurrence of pancreatic cancer following surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, the patient will have already signed an informed consent form, indicating understanding and agreement to participate in the study.

    The patient must meet specific health criteria, including a confirmed diagnosis of pancreatic ductal adenocarcinoma and a complete surgical resection of the tumor.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility, which includes a review of medical history and current health status.

    Laboratory tests will be conducted to ensure the patient meets the necessary health parameters for participation.

  3. Step 3

    Phase I treatment

    The patient will receive a combination of medications known as mFOLFIRINOX, which includes folinic acid, irinotecan hydrochloride, fluorouracil, and oxaliplatin, administered through intravenous infusion.

    Additionally, the patient may receive BNT321, a human antibody, also administered as a solution for infusion.

    The primary goal of this phase is to assess the safety and determine the recommended dose of BNT321 when combined with mFOLFIRINOX.

  4. Step 4

    Phase II treatment

    In this phase, the patient will continue to receive mFOLFIRINOX, with or without BNT321, based on randomization.

    The focus is on evaluating the effectiveness of the treatment in preventing the return of cancer after surgery.

  5. Step 5

    Regular monitoring

    Throughout the trial, the patient will attend scheduled visits for health monitoring, including laboratory tests and imaging studies to assess the response to treatment.

    The patient will be monitored for any side effects or adverse reactions to the medications.

  6. Step 6

    Completion of treatment

    Upon completion of the treatment cycles, the patient will undergo a final assessment to evaluate the overall health status and treatment outcomes.

    The patient will continue to be monitored for any long-term effects or recurrence of the disease.

Who can join the trial?

16 criteria

  • You must sign a form that shows you understand and agree to participate in the study.
  • You should be willing and able to attend scheduled visits, follow the treatment plan, and adhere to any lifestyle restrictions required by the study.
  • You need to have an ECOG performance status of 0 to 1, which means you are fully active or have some symptoms but can still do light work.
  • If you are a man who is sexually active with a woman who can become pregnant, you must agree to use condoms with a sperm-killing agent and ensure your partner uses a highly effective form of birth control during the study and for a specified time after the last dose of the study drugs.
  • You must have a confirmed diagnosis of pancreatic ductal adenocarcinoma (PDAC), a type of pancreatic cancer.
  • You should have had a complete surgical removal of the tumor (R0 or R1 resection) between 21 and 84 days before starting the study medication. You also need to provide tumor tissue from the surgery or a biopsy.
  • You must not have any signs of cancer spread, such as in other organs or fluid buildup in the abdomen or around the lungs, based on a scan done within four weeks before starting the study medication.
  • If you are a man, you must agree not to donate sperm during the study and for a specified time after the last dose of the study drugs.
  • If you are a woman who can become pregnant, you must agree to use a highly effective form of birth control and ensure your male partner uses condoms with a sperm-killing agent during the study and for a specified time after the last dose of the study drugs. If you cannot use a highly effective method for medical reasons, using condoms with a sperm-killing agent is acceptable.
  • You must have fully recovered from surgery and be able to receive chemotherapy.
  • Your blood tests must show acceptable levels, including white blood cells, red blood cells, platelets, liver enzymes, bilirubin, kidney function, and protein levels.
  • If you are a woman who can become pregnant, you must have a negative pregnancy test at the start of the study. Women who are postmenopausal or permanently sterilized do not need to take this test.
  • You must agree to allow the collection of blood samples to study how the drug moves through your body.
  • If you are a woman who can become pregnant, you must agree not to donate eggs for assisted reproduction during the study and for a specified time after the last dose of the study drugs.
  • You must agree not to participate in another study involving an experimental drug during this study.
  • You must be over 18 years old or considered an adult according to local laws when you sign the consent form.

Who cannot join the trial?

7 criteria

  • Patients who have not had surgery to remove their pancreatic cancer.
  • Patients who have not been diagnosed with pancreatic ductal adenocarcinoma, a type of pancreatic cancer.
  • Patients who have not had their cancer completely or partially removed (R0 or R1 resection).
  • Patients who are not able to safely receive the study treatment.
  • Patients who are not in the age range specified for the study.
  • Patients who are not able to follow the study procedures or attend study visits.
  • Patients who are part of a vulnerable population that the study cannot safely include.
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Investigated drugs

  • BNT321

    is an investigational medication being studied for its potential use in treating pancreatic cancer. In this trial, it is being tested to see if it can be safely combined with another treatment regimen and to determine the best dose to use in future studies. The goal is to see if adding BNT321 can help improve outcomes for patients who have had surgery to remove pancreatic cancer.

  • mFOLFIRINOX

    is a combination of chemotherapy drugs used to treat pancreatic cancer. It includes several medications that work together to kill cancer cells and prevent them from growing. In this trial, mFOLFIRINOX is being used as a standard treatment to see if it is more effective when combined with BNT321 compared to using mFOLFIRINOX alone.

What is already known about the treatment

BNT321 – BNT321 is administered intravenously and is currently being studied in clinical trials as an adjuvant therapy for pancreatic ductal adenocarcinoma following surgical resection. It is in the investigational stage, with ongoing research to determine its safety and efficacy. The main therapeutic indication is for patients who have undergone surgery for pancreatic cancer. BNT321 works by targeting specific cancer cell markers, potentially enhancing the immune system's ability to fight cancer cells. It is classified as an investigational monoclonal antibody.

Investigated diseases

Pancreatic Ductal Adenocarcinoma – This is a type of cancer that begins in the ducts of the pancreas, which is an organ located behind the stomach. It is known for its aggressive nature and tendency to spread quickly to nearby organs. The disease often progresses silently, with symptoms appearing only in advanced stages, such as jaundice, weight loss, and abdominal pain. Surgical resection, where the tumor is removed, is a common approach when the cancer is detected early enough. However, even after surgery, there is a risk of recurrence, making ongoing monitoring and additional treatments necessary. The disease's progression can vary, but it typically involves the growth of cancerous cells that can invade other parts of the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-506014-47-00Protocol codeBNT321-02Estimated enrolment260 patientsSponsorBioNTech SE

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