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Study of Pembrolizumab, Dendritic Cell Vaccine, Trifluridine/Tipiracil, and Bevacizumab for Patients with 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 clinical trial is focused on studying a treatment for metastatic colorectal cancer, which is a type of cancer that has spread from the colon or rectum to other parts of the body. The study involves a combination of treatments, starting with Pembrolizumab, a medication that helps the immune system fight cancer, and a Dendritic Cell (DC) Vaccine, which is a type of cell therapy designed to stimulate the immune system. This is followed by a combination of Trifluridine/Tipiracil, a chemotherapy drug, and Bevacizumab, a medication that helps prevent the growth of blood vessels that feed tumors.

The purpose of the study is to evaluate the effectiveness of this sequential treatment approach. Participants will first receive the immunotherapy treatment with Pembrolizumab and the DC Vaccine. After this phase, they will receive the chemotherapy drugs Trifluridine/Tipiracil along with Bevacizumab. The study will monitor the response of the cancer to these treatments and assess the overall health and safety of the participants throughout the process.

The trial aims to provide insights into how well this combination of treatments works for patients with mismatch-repair-proficient (pMMR) or microsatellite-stable (MSS) metastatic colorectal cancer. These terms refer to specific characteristics of the cancer cells that can influence how they respond to treatment. The study will also look at how long patients live without the cancer getting worse and record any side effects experienced during the treatment. Participants will be closely monitored to ensure their safety and to gather detailed information about the treatment's impact on their cancer and overall health.

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

    Initial treatment phase

    Receive an injection of autologous tumor lysate-loaded dendritic cells intradermally. This is a cell suspension for injection.

    Begin treatment with Pembrolizumab, administered as an intravenous infusion. This is a solution for infusion.

  2. Step 2

    Combination therapy phase

    Start taking Lonsurf tablets orally. The dosage includes two types of film-coated tablets: 20 mg/8.19 mg and 15 mg/6.14 mg.

    Receive Bevacizumab as an infusion. This is a solution for infusion.

  3. Step 3

    Monitoring and evaluation

    Undergo regular assessments to monitor the response to treatment. This includes imaging tests to evaluate the size and spread of the cancer.

    Participate in safety evaluations to record any adverse effects experienced during the treatment period.

  4. Step 4

    Follow-up

    Continue to be monitored for overall survival and progression-free survival. This involves tracking the time from the start of treatment to any progression of the disease or other significant events.

    Participate in additional tests to understand the immune response and other biological markers related to the treatment.

Who can join the trial?

12 criteria

  • The participant must be willing and able to provide written consent to join the study.
  • The patient must have a disease that can be measured using a CT or MRI scan of the chest, abdomen, and pelvis.
  • The patient should have had 1-2 previous chemotherapy treatments for advanced cancer, including specific drugs if suitable.
  • The patient must have normal organ and blood function, which includes having enough white blood cells, neutrophils, and platelets, and normal levels of bilirubin, liver enzymes, and creatinine.
  • A sample from a previous surgery must have been collected and sent to a specific lab for vaccine preparation.
  • The patient must have recovered from any side effects of previous surgery to a mild level.
  • Female participants must not be pregnant or breastfeeding. Women who can become pregnant and all male patients with partners who can become pregnant must use a highly effective birth control method.
  • The patient must have a specific type of colorectal cancer confirmed by a lab test.
  • The participant can be male or female and must be 18 years or older.
  • The patient must have a life expectancy of more than 12 weeks.
  • The patient must have a performance status that shows they are able to carry out daily activities with some limitations.
  • The patient must be suitable for a procedure to collect blood cells, which includes having negative tests for certain infections, normal heart function, and recovery from previous treatment side effects.

Who cannot join the trial?

4 criteria

  • Patients with other types of cancer besides metastatic colorectal cancer cannot participate. Metastatic means the cancer has spread to other parts of the body.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who do not meet the specific health requirements or conditions set by the study cannot participate.
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Investigated drugs

  • Pembrolizumab

    is a type of immunotherapy that helps the immune system recognize and attack cancer cells. It is used in this trial to treat metastatic colorectal cancer.

  • Dendritic Cell (DC) Vaccine

    is a therapy that uses a type of immune cell called dendritic cells to help stimulate the body's immune response against cancer cells. It is combined with Pembrolizumab in this trial.

  • Trifluridine/Tipiracil

    is a chemotherapy medication used to slow down or stop the growth of cancer cells. It is used in this trial after the initial immunotherapy treatment.

  • Bevacizumab

    is a medication that works by blocking the blood supply to tumors, which can slow their growth. It is used in combination with Trifluridine/Tipiracil in this trial.

What is already known about the treatment

  • Pembrolizumab

    This medication is administered via intravenous infusion and is currently used in the treatment of various cancers, including metastatic colorectal cancer. It is a monoclonal antibody that works by blocking a specific protein on immune cells, allowing the immune system to better attack cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor and is well-documented in medical literature for its role in cancer immunotherapy.

  • Dendritic Cell Vaccine

    This vaccine is administered through injection and is used in experimental treatments for cancer, including metastatic colorectal cancer. It works by stimulating the body's immune system to recognize and attack cancer cells more effectively. The vaccine is still under investigation in clinical trials and is part of a growing field of cancer immunotherapy.

  • Trifluridine/Tipiracil

    This oral medication is used in the treatment of metastatic colorectal cancer. It combines two components: trifluridine, which interferes with DNA synthesis in cancer cells, and tipiracil, which helps maintain trifluridine levels in the body. It is classified as an antineoplastic agent and is recognized in medical literature for its role in chemotherapy.

  • Bevacizumab

    Administered via intravenous infusion, this medication is used to treat various cancers, including metastatic colorectal cancer. It works by inhibiting the growth of blood vessels that supply nutrients to tumors, effectively starving the cancer cells. Bevacizumab is classified as an angiogenesis inhibitor and is well-established in medical literature for its use in cancer treatment.

Investigated diseases

Metastatic colorectal cancer – This is a type of cancer that begins in the colon or rectum and has spread to other parts of the body, such as the liver or lungs. It typically starts as a growth, called a polyp, on the inner lining of the colon or rectum, which can become cancerous over time. As the cancer progresses, it can invade nearby tissues and organs, and eventually spread through the lymphatic system or bloodstream to distant sites. The progression of the disease can vary, with some patients experiencing rapid spread, while others may have a slower progression. Symptoms may include changes in bowel habits, blood in the stool, abdominal pain, and unexplained weight loss. The disease is often diagnosed at an advanced stage due to the lack of early symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514053-30-00Protocol codeIRST153.09Estimated enrolment36 patientsSponsorIstituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.

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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).