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Oxaliplatin-based drug combination (including bevacizumab, tislelizumab, fluorouracil, folic acid) for patients with diagnosed metastatic colorectal cancer

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What is this trial about?

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

The trial examines patients with metastatic colorectal cancer, a type of bowel cancer that has spread to other organs. Only tumors that show the MSS/pMMR pattern (a form that usually does not trigger the immune system) are considered, and a laboratory test called next-generation sequencing looks at many genes in the tumor to decide eligibility. The treatment plan alternates a short course of chemotherapy that includes oxaliplatin, fluorouracil and folic acid together with the targeted drug bevacizumab, followed by the immune‑boosting medicine tislelizumab. The purpose is to determine whether this combination can keep the cancer from growing.

Participants receive the chemotherapy and bevacizumab by IV infusion for a few weeks, then switch to tislelizumab for another short period, and this cycle repeats several times. Doctors watch for safety, tumor response, and overall survival, while the main measure of success is progression-free survival, meaning the length of time the disease does not get worse. The study follows patients for several months to assess these outcomes.

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

    Baseline Assessments

    After joining the study, you will undergo a series of baseline examinations that include a physical exam, blood tests, and imaging scans to document the extent of the disease.

    Your tumor tissue will be analyzed for genetic characteristics that determine eligibility for the specific treatment regimen.

  2. Step 2

    First Chemotherapy Cycle With Bevacizumab

    You will receive an intravenous (IV) infusion that contains four medicines:

    Oxaliplatin 20 mg per square meter of body surface area, fluorouracil 150 mg per square meter, calcium folinate 0.15 mg per kilogram of body weight, and bevacizumab 0.36 mg per kilogram.

    All four drugs are given through a vein over a period of several hours, according to the study schedule.

  3. Step 3

    Repeating Chemotherapy Cycles With Bevacizumab

    The same combination of oxaliplatin, fluorouracil, calcium folinate, and bevacizumab will be administered repeatedly in subsequent cycles.

    Each cycle follows the same dosing amounts and is given on the interval defined by the study protocol (for example, every two weeks).

    You will be monitored closely before each infusion to ensure that blood counts and organ function remain within safe limits.

  4. Step 4

    Alternating Immunotherapy Cycle With Tislelizumab

    After a predetermined number of chemotherapy cycles, the study protocol alternates the treatment.

    During an alternating cycle, you will receive an IV infusion of tislelizumab 11 mg, while the other three chemotherapy drugs are omitted for that visit.

    This immunotherapy infusion is also given according to the study schedule and is followed by the same safety assessments as the chemotherapy cycles.

  5. Step 5

    Ongoing Safety and Efficacy Monitoring

    Throughout the treatment period, regular blood tests, physical examinations, and imaging studies (such as CT scans) will be performed to check how the disease is responding and to detect any side effects.

    Any adverse effects that arise will be evaluated and managed according to the study’s safety guidelines.

  6. Step 6

    Completion of Treatment and Final Evaluation

    When the planned number of cycles has been completed, you will undergo a final set of assessments that include imaging, laboratory tests, and a physical exam.

    These results will be used to determine the overall outcome of the treatment, including disease progression and overall survival.

Who can join the trial?

13 criteria

  • You must have a colon cancer diagnosis confirmed by looking at tissue under a microscope, and the cancer must be the type called MSS/pMMR (meaning it does not have certain DNA repair problems). This also includes the mucinous and signet‑ring cell forms.
  • You need a sample of your tumor (taken by biopsy or surgery) that can be tested with next‑generation sequencing (NGS) using the study’s OCAP platform.
  • You must be able to move around on your own (ambulatory) and have an ECOG performance status of 0 or 1, which means you are fully active or able to do light work but not strenuous activity.
  • You must be at least 18 years old.
  • Your disease must be visible on imaging (such as a CT or MRI) and show measurable spread, with at least one metastasis located below the diaphragm (in the abdomen).
  • You must not have received any chemotherapy that kills cancer cells for the metastatic disease, except if you had a pre‑surgery (neoadjuvant) treatment that ended at least six months ago.
  • Your doctors must consider the chemotherapy regimen FLOX/FOLFOX with bevacizumab to be the preferred first‑line treatment for you.
  • Your recent lab tests (done within the past two weeks) must show that your major organs (like liver, kidneys, and blood‑forming system) are working well.
  • If you are a woman who could become pregnant (WOCBP), you must have a negative pregnancy test (blood or urine) within 24 hours before starting the study drug.
  • If you are a WOCBP, you must agree to use reliable birth‑control methods for 26 weeks after your last dose of the study drug.
  • You must not be breastfeeding.
  • If you are a man who has sexual contact with a WOCBP, you must agree to use birth‑control methods for 26 weeks after the last dose of the study drug.
  • You must sign the informed consent form (ICF) and agree to follow the study visits and procedures as required by good clinical practice rules.

Who cannot join the trial?

22 criteria

  • Having metastatic colorectal cancer that shows MSI/dMMR (a type of genetic change that makes the cancer behave differently) excludes you.
  • If your metastatic disease can be removed by surgery right away and does not need treatment before surgery (neoadjuvant therapy), you cannot join.
  • Having cancer spread only above the diaphragm (such as only in the lungs or brain) excludes you.
  • Having untreated or symptom‑causing brain tumors, or needing steroids to control brain tumor symptoms, excludes you.
  • If you stopped previous chemotherapy that contained oxaliplatin less than 6 months ago, you are not eligible.
  • If you cannot receive the full standard dose of chemotherapy in the first treatment cycle, you cannot participate.
  • Having a partial or complete DPD deficiency (a lack of an enzyme that helps break down certain chemotherapy drugs) excludes you.
  • If you received radiation treatment to the only measurable tumor within 4 weeks before starting the study, you are not eligible.
  • If you are on a blood‑thinning medication that cannot be switched to low‑molecular‑weight heparin (LMWH) or a direct oral anticoagulant during the study, you cannot join.
  • Having a nervous system disorder that is worse than mild (CTCAE grade 1) excludes you.
  • If any medical condition would prevent you from receiving an immune checkpoint inhibitor (a type of immunotherapy), you are not eligible.
  • Using medicines that suppress the immune system within 28 days before the first study dose (except nasal steroid sprays or low‑dose systemic steroids not above 10 mg/day of prednisone) excludes you.
  • If you have a medical condition or need a medication listed in the study drug information that would stop you from receiving the study medication, you cannot participate.
  • Having taken any investigational drug that could interfere with the study treatment within 4 weeks before the first dose excludes you.
  • Known allergy (hypersensitivity) to any part of the study drug ingredients excludes you.
  • Having an ECOG performance status of 2 or higher (meaning you need considerable help with daily activities) excludes you.
  • Having a blood test showing CRP (a marker of inflammation) of 60 mg/L or higher excludes you.
  • If your lab results do not show adequate organ function (such as liver, kidney, or bone marrow), you cannot join.
  • Having a previous cancer, except for certain skin cancers, early‑stage cervical cancer, early‑stage prostate cancer, or another cancer that was cured more than 5 years ago and has not come back, excludes you.
  • Having serious heart, lung, or other illnesses that limit your daily activities (ADL) or life expectancy excludes you.
  • Being pregnant or breastfeeding excludes you.
  • Any other reason the study doctor decides you should not take part also excludes you.
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Investigated drugs

  • Bevacizumab

    is a medication that blocks a protein that helps tumors grow new blood vessels. In this trial it is given together with chemotherapy to try to keep the cancer from getting enough blood supply, which may help the other drugs work better.

  • Oxaliplatin

    is a platinum‑based chemotherapy drug that damages the DNA of cancer cells, making it harder for them to grow and divide. It is part of the short‑course chemotherapy regimen used at the start of treatment in the study.

  • Tislelizumab

    is an immune checkpoint inhibitor that helps the body’s own immune system recognize and attack cancer cells. In the trial it is given after the initial chemotherapy cycles, alternating with the chemotherapy to try to turn a non‑immunogenic tumor into one that the immune system can target.

  • Calcium folinate

    (also called folic acid) is used to boost the effect of fluorouracil, another chemotherapy drug. It helps the cancer‑killing action of fluorouracil work more effectively.

  • Fluorouracil

    is a chemotherapy medication that interferes with the production of DNA in rapidly growing cells, such as cancer cells. It is combined with oxaliplatin and calcium folinate as part of the chemotherapy regimen given in the study.

What is already known about the treatment

  • Bevacizumab

    This drug is given as an intravenous infusion of a clear solution. It is an approved medication used worldwide to treat several cancers, including metastatic colorectal cancer. It works by binding to a protein called VEGF, which stops new blood vessels from feeding the tumor. Bevacizumab belongs to the class of monoclonal antibodies that act as anti‑angiogenic agents.

  • Oxaliplatin

    Oxaliplatin is administered by intravenous infusion of a sterile solution. It is an approved platinum‑based chemotherapy for colorectal cancer and is commonly used together with other drugs. The medicine creates cross‑links in DNA, which prevents cancer cells from dividing and leads to their death. It is classified as a platinum compound and an alkylating‑like agent.

  • Tislelizumab

    Tislelizumab is delivered as an intravenous infusion of a concentrated solution. It has received regulatory approval for several solid tumors and is being studied in colorectal cancer. The drug blocks the PD‑1 checkpoint on immune cells, allowing the body’s immune system to recognize and attack the tumor. It is a monoclonal antibody classified as an immune checkpoint inhibitor.

  • Calcium folinate

    Calcium folinate is given by a quick intravenous injection or short infusion of a sterile solution. It is an approved supportive medication used with 5‑fluorouracil‑based regimens for colorectal cancer. The compound provides a reduced form of folic acid that enhances the action of fluorouracil on cancer cells. It is classified as a folate analog and a chemotherapy adjuvant.

  • Fluorouracil

    Fluorouracil is administered by intravenous injection or infusion of a sterile solution. It is a long‑standing, approved chemotherapy used for colorectal cancer and many other solid tumors. The drug mimics the natural building block uracil, interfering with DNA synthesis and causing cancer cells to die. It belongs to the antimetabolite class of pyrimidine analogues.

Investigated diseases

Metastatic colorectal cancer - Colorectal cancer that has spread from the original tumor in the colon or rectum to other parts of the body, most often the liver, lungs, or peritoneum. The disease begins as a growth in the lining of the large intestine and then invades surrounding tissue before entering the bloodstream or lymphatic system. Once cancer cells reach distant sites they form new tumor nodules that can continue to grow and interfere with normal organ function. Over time the spread can involve multiple abdominal regions, leading to increasing disease burden.
Trial detailsLast updated 7 Nov 2026
Age18+ yearsPhasePhase IITrial ID2026-526317-29-00Protocol codeMETIMMOX-3Estimated enrolment77 patientsSponsorAkershus University Hospital

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