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Study of Pembrolizumab and Temozolomide for Patients with Metastatic Colorectal Cancer Who Have Not Responded to Standard Treatments

Fast replyRegistered 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 a type of cancer called metastatic colorectal cancer, which is a form of cancer that starts in the colon or rectum and spreads to other parts of the body. The study is investigating the effects of a treatment using a medication called pembrolizumab, also known by its code name MK-3475, and another medication called temozolomide. Pembrolizumab is given as an infusion, which means it is administered directly into the bloodstream through a vein, while temozolomide is taken orally in capsule form.

The purpose of the study is to evaluate how well pembrolizumab works in patients with a specific type of metastatic colorectal cancer that has certain genetic characteristics. These patients have already tried standard treatments without success. The study involves a process called "priming," where temozolomide is used to prepare the cancer cells to respond better to pembrolizumab. This priming phase aims to increase the number of mutations in the cancer cells, which may make them more responsive to the treatment.

Participants in the study will receive pembrolizumab and temozolomide over a period of time, with regular monitoring to assess the response of the cancer to the treatment. The study will also look at the safety and tolerability of pembrolizumab, both on its own and after the priming with temozolomide. The trial is designed to gather information on how long patients live without the cancer getting worse and overall survival rates. The study is expected to continue until June 2025.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Screening phase

    A diagnosis of metastatic colorectal cancer is confirmed through tissue analysis.

    Consent is obtained for participation in the screening phase.

    Two tumor biopsies are required if eligible for the priming phase.

    Previous treatment failure with standard therapies is documented through imaging.

    A performance status is assessed to ensure normal daily activity levels.

    Tests are conducted to confirm specific genetic and protein markers in the tumor tissue.

    Normal organ function is verified through medical tests.

  2. Step 2

    Priming phase

    Consent is obtained for participation in the priming phase.

    Two tumor biopsies are performed to assess the tumor's genetic characteristics.

    The patient is informed that if the mutational load cannot be determined, access to the trial phase will not be possible.

    The patient receives temozolomide orally to increase the mutational load of the tumor. The dosage and frequency are determined by the medical team based on individual needs.

  3. Step 3

    Trial phase

    Consent is obtained for participation in the trial phase.

    The patient receives pembrolizumab through an intravenous infusion. The dosage and frequency are determined by the medical team based on individual needs.

    The patient's response to the treatment is monitored through regular imaging and medical assessments.

    Normal organ function is verified through medical tests before starting the treatment.

    Women of childbearing potential must complete a pregnancy test and use effective contraceptive methods during the trial.

Who can join the trial?

14 criteria

  • Must have a confirmed diagnosis of metastatic colorectal cancer, which means the cancer has spread from the colon or rectum to other parts of the body.
  • Must be at least 18 years old.
  • Must sign an informed consent form, which is a document that explains the study and confirms your willingness to participate.
  • Must agree to undergo two tumor biopsies, which are procedures to remove a small sample of tissue for testing.
  • Must have tried standard treatments for colorectal cancer, such as fluoropyrimidine, oxaliplatin, and irinotecan, with or without other drugs like Bevacizumab, Aflibercept, or Regorafenib, and these treatments must not have worked.
  • Must have at least one tumor that can be measured using imaging tests, like a CT scan or MRI, and this must be done within 28 days before joining the study.
  • Must have a performance status of 0 or 1 on the ECOG scale, which means you are fully active or have some symptoms but can still do light work.
  • Must have normal organ functions, which means your organs like the liver and kidneys are working properly.
  • Must have a specific genetic status called proficient MMR or MSI-Low, which are types of genetic stability in the cancer cells.
  • Must have a negative result for the MGMT protein test, which checks for a specific protein in the tumor.
  • Must have a positive result for MGMT promoter methylation, which is a specific change in the DNA of the tumor.
  • Must have documented RAS extended mutations, which are specific changes in the cancer's genes.
  • Women who can have children must take a pregnancy test and agree to use effective birth control methods during the study.
  • Must have blood tests showing normal organ functions within 10 days before starting the study treatment.

Who cannot join the trial?

8 criteria

  • Patients who do not have **metastatic colorectal cancer**. This means the cancer has spread from the colon or rectum to other parts of the body.
  • Patients who are not **MMR proficient**. MMR stands for "mismatch repair," which is a system in the body that fixes mistakes in DNA. Being proficient means this system works well.
  • Patients who do not have **extended RAS mutations**. RAS is a group of genes, and mutations in these genes can affect cancer growth.
  • Patients who have not failed standard therapies. This means they have not tried and not responded to the usual treatments for their cancer.
  • Patients who do not have **MGMT-negative tumors**. MGMT is a gene, and being negative means the gene is not active in the tumor.
  • Patients who are not treated with **TMZ**. TMZ stands for temozolomide, a type of chemotherapy used to treat certain cancers.
  • Patients who are not within the specified age range. The trial is open to certain age groups only.
  • Patients who are part of a vulnerable population. This means groups of people who might need special protection or care.
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Investigated drugs

  • Pembrolizumab

    is a medication used in this trial to treat patients with a specific type of colorectal cancer that has spread to other parts of the body. It works by helping the immune system recognize and attack cancer cells more effectively.

  • TMZ

    (Temozolomide) is used in this trial to treat tumors that are MGMT-negative. The goal of using TMZ is to increase the number of mutations in the cancer cells, which may make them more responsive to treatment with pembrolizumab.

What is already known about the treatment

Pembrolizumab – This medication is administered intravenously, typically through an infusion. It is currently being studied in clinical trials for its effectiveness in treating metastatic colorectal cancer, particularly in patients with specific genetic profiles. Pembrolizumab is primarily used for its immune-boosting properties, helping the body's immune system recognize and attack cancer cells. It works by blocking a protein called PD-1 on the surface of immune cells, which can otherwise inhibit the immune response against cancer. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of immunotherapy.

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. It often progresses through the lymphatic system or bloodstream, reaching organs such as the liver or lungs. The disease may initially present with symptoms like changes in bowel habits, blood in the stool, or abdominal discomfort. As it advances, it can lead to more severe symptoms depending on the organs affected. The spread of cancer cells can cause complications in the affected organs, impacting their function. The progression of the disease varies among individuals, influenced by factors like the cancer's genetic mutations and the patient's overall health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518526-33-01Protocol codeCPT002/2018/PO001Estimated enrolment822 patientsSponsorIfom Istituto Fondazione Di Oncologia Molecolare Ets In Breve Ifom Ets

sourced from the EU Clinical Trials Register and site verification

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