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A study of pumitamig and a drug combination versus bevacizumab and a drug combination for patients with untreated, unresectable, or metastatic colorectal cancer

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What is this trial about?

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

This study is designed to compare the effectiveness of different treatment combinations for people with Colorectal Cancer that has not been treated before, cannot be removed by surgery, or has spread to other parts of the body. The research focuses on comparing a combination involving the drug pumitamig, also known as BNT327, with a standard treatment combination that includes bevacizumab.

The treatment groups will receive various medications. One group will receive a combination of pumitamig with several chemotherapy drugs, including oxaliplatin, calcium folinate, fluorouracil, irinotecan hydrochloride trihydrate, and capecitabine. These drugs are administered through different methods, such as an infusion, which is a liquid medicine delivered directly into a vein, or by oral use, which means taking the medicine by mouth. The other group will receive a combination of bevacizumab along with a set of chemotherapy drugs.

The study is divided into two stages. The first stage aims to see how many people experience a reduction in tumor size after receiving the treatment. The second stage focuses on observing how long the treatment keeps the cancer from growing or spreading further. Throughout the process, information is gathered to understand how well the medicines work and how they are tolerated by the body.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study entry and treatment assignment

    Upon joining the study, a randomization process occurs, which means a method is used to assign you to one of two different treatment groups by chance.

    You will receive either a combination of a test drug called pumitamig with chemotherapy or a combination of a comparator drug called bevacizumab with chemotherapy.

  2. Step 2

    Treatment with pumitamig and chemotherapy

    If assigned to the test group, you will receive pumitamig, which is administered as an infusion (a liquid passed into the body through a vein).

    This group also receives chemotherapy, which are medicines used to treat cancer. the specific medicines in this group may include oxaliplatin, calcium folinate, fluorouracil, irinotecan hydrochloride trihydrate, or capecitabine, which is taken by mouth.

  3. Step 3

    Treatment with bevacizumab and chemotherapy

    If assigned to the comparator group, you will receive bevacizumab through an infusion into a vein.

    This group also receives chemotherapy medicines, which may include oxaliplatin, calcium folinate, fluorouracil, irinotecan hydrochloride trihydrate, or capecitabine, which is taken by mouth.

  4. Step 4

    Monitoring and evaluation

    During the trial, the tumor response, which is how the cancer reacts to the medicine, is monitored to see how many people benefit from the treatment.

    The progression-free survival is tracked, which measures the time from the start of the treatment until the disease gets worse or death occurs.

    Other observations include overall survival, which is the length of time lived, and duration of response, which measures how long the medicine continues to control tumor growth.

Who can join the trial?

6 criteria

  • You must be at least 18 years old.
  • You must have colorectal cancer (cancer in the large intestine or rectum) that has returned, spread to other parts of the body, or cannot be removed through surgery (an operation to cut out the tumor).
  • You must not have received any previous cancer treatments.
  • You must not have a specific type of colorectal cancer known as dMMR/MSI-H, which refers to certain genetic changes in how cells repair their DNA.
  • You must not have a BRAF V600E gene mutation, which is a specific change or error in the DNA that can cause cancer cells to grow.
  • Your cancer must be large enough or in a location that can be seen and measured using a scan (an imaging test like a CT or MRI).

Who cannot join the trial?

4 criteria

  • You cannot participate if your cancer has spread to the brain, spinal cord, or nearby areas and has not been treated (received medical care to stop or manage the disease).
  • You cannot participate if you have had another type of active cancer (cancer that is currently growing or spreading) within the last 2 years, unless it was a low-risk case that was cured locally (successfully treated in one specific area).
  • You cannot participate if you have serious heart problems, such as a recent heart attack (when blood flow to the heart is blocked), a stroke (when blood flow to the brain is blocked), blocked arteries (narrowing of the tubes that carry blood), uncontrolled high blood pressure, or certain genetic heart rhythm issues (irregular heartbeats caused by your DNA).
  • You cannot participate if you have already taken checkpoint inhibitors (medicines that help the immune system fight cancer), CD137 agonists (a type of drug that stimulates the immune system), or chemotherapy (medicine used to kill cancer cells).
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Investigated drugs

  • Pumitamig

    is a medication being tested in this study to see how well it works when combined with other cancer treatments. It is given through an IV infusion.

  • Oxaliplatin

    is a type of chemotherapy medicine used to treat cancer. It is administered as a solution through an IV infusion.

  • Calcium folinate

    is a medication used alongside certain chemotherapy drugs to help manage how the body reacts to the treatment or to improve its effectiveness. It is given as an injection.

  • Fluorouracil

    is a common chemotherapy drug used to treat various types of cancer. It is administered as a solution through an IV injection or infusion.

  • Capecitabine

    is a chemotherapy medication that is taken by mouth in pill form.

  • Irinotecan

    is a chemotherapy drug used to treat cancer. It is administered as a solution through an IV infusion.

What is already known about the treatment

  • Oxaliplatin

    This medication is administered as a solution through an intravenous infusion to treat various types of cancer. As a widely used chemotherapy agent, it works by binding to and damaging the DNA within cancer cells, which prevents them from multiplying. It belongs to a class of drugs known as platinum-based antineoplastic agents.

  • Calcium folinate

    This substance is given as an injection into a vein to help manage the effects of certain cancer treatments. It is a well-established medical tool used to protect healthy cells and enhance the effectiveness of specific chemotherapy drugs. It acts by providing a specialized form of vitamin B that supports cellular processes during treatment.

  • Fluorouracil

    This drug is administered via an injection into the bloodstream and is a standard treatment for several types of cancer. It functions by mimicking the building blocks of DNA, which tricks cancer cells into incorporating it, ultimately stopping their growth. It is classified as an antimetabolite chemotherapy medication.

  • Pumitamig

    This investigational drug is provided as a concentrated solution for intravenous infusion and is currently being studied for its ability to treat colorectal cancer. It works by targeting specific proteins on the surface of cancer cells to help the immune system recognize and destroy them. This substance is classified as an antibody-drug conjugate.

  • Capecitabine

    This medication is taken orally in pill form and is commonly used to treat various cancers. It is a specialized drug that travels through the body and is converted into an active chemotherapy agent specifically inside tumor cells. It belongs to a class of drugs called antimetabolites.

  • Bevacizumab

    This medication is administered as an intravenous infusion and is used as a standard comparison treatment in cancer clinical trials. It works by blocking a specific protein that helps tumors grow new blood vessels, effectively starving the tumor of nutrients. It is classified as a targeted therapy known as an angiogenesis inhibitor.

Investigated diseases

Colorectal cancer - This disease occurs when abnormal cells form in the colon or the rectum. These cells grow uncontrollably and can form a mass known as a tumor. As the condition progresses, the cancer cells may spread from their original location to nearby tissues or distant organs in the body. In some cases, the tumor becomes difficult to remove through surgery. The disease can also present in a state where it has already moved to other parts of the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-523224-45-00Protocol codeCA2660003Estimated enrolment990 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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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).