Study on the Safety and Effectiveness of mFOLFIRINOX with or without BNT321 as Additional Treatment After Surgery for Pancreatic Cancer

Sponsor: BioNTech SE

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06069778

Provider View

This clinical trial is testing a combination of chemotherapy and a new drug, BNT321, to see if it is safe and effective as an additional treatment after surgery for pancreatic cancer. The study will explore different doses and compare outcomes with and without BNT321.

Patient Parameters

Program Overview

This study is investigating whether adding a new drug, BNT321, to the standard chemotherapy treatment mFOLFIRINOX can improve outcomes for patients who have had surgery to remove pancreatic cancer. The trial will start by testing different doses of BNT321 to find the safest and most effective amount. Once the best dose is determined, the study will compare the effects of mFOLFIRINOX with and without BNT321 on patients' recovery and survival. The treatment will be given every two weeks, and the study will monitor patients for side effects and how well the cancer is controlled.

Description

The trial is divided into two phases. In Phase I, researchers will test different doses of BNT321 combined with mFOLFIRINOX chemotherapy to find the safest and most effective dose. This phase will involve a small group of patients to ensure the treatment is safe. Once the best dose is identified, the study will move to Phase II.

In Phase II, a larger group of patients will be randomly assigned to receive either mFOLFIRINOX alone or mFOLFIRINOX with BNT321. This phase aims to determine if adding BNT321 improves the time patients remain free of cancer and their overall survival. Researchers will also study how the body processes the drugs and any immune responses triggered by the treatment.

Throughout the study, patients will receive treatment every two weeks and will be closely monitored for side effects and the effectiveness of the treatment. The study will also collect blood samples to understand how the drugs work in the body and their impact on the cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and have signed a consent form agreeing to participate.
  • Able to attend scheduled visits and follow the treatment plan.
  • Have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
  • Diagnosed with pancreatic cancer and have had surgery to remove the tumor.
  • No signs of cancer spread to other parts of the body.
  • Fully recovered from surgery and ready to start chemotherapy.
  • Willing to provide blood samples for research purposes.
  • Agree not to participate in other clinical trials during this study.
  • Women of childbearing potential must not be pregnant and agree to use effective birth control during the study and for a specified time after treatment.
  • Men must agree to use birth control and not donate sperm during the study and for a specified time after treatment.

Exclusion Criteria

  • Pregnant or breastfeeding women, or those planning to become pregnant or father children during the study.
  • Have a medical or psychological condition that could affect participation or safety in the study.
  • Have had major surgery recently that could affect recovery.
  • Have significant heart problems or abnormal heart rhythms.
  • Have a history of severe allergic reactions to similar drugs.
  • Have other active cancers that may need treatment soon.
  • Have had previous treatment for pancreatic cancer.
  • Have active infections that require treatment.
  • Have a history of HIV, hepatitis B, or hepatitis C infections that are not well controlled.
  • Have received another investigational drug or device recently.
  • Have certain genetic conditions or enzyme deficiencies that affect drug metabolism.
  • Have received a live vaccine recently.
  • Have a history of tuberculosis or are currently infected.

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