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Study of Dostarlimab for Patients with Untreated Stage III Resectable Colon 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 type of colon cancer known as resectable colon cancer, specifically in patients with a subtype called pMMR/MSS. The treatment being tested is a medication called Dostarlimab, which is also known by its code names WBP-285 and TSR-042. Dostarlimab is given as a solution through an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to observe the changes in the body at a molecular level when patients with untreated colon cancer receive Dostarlimab before surgery. This approach is known as neoadjuvant therapy, which means the treatment is given to shrink the tumor before it is surgically removed. The study will help create a database of these changes, which can be used for future research. Participants will receive Dostarlimab and will be monitored for any changes in their condition, as well as for any side effects that may occur during the treatment period.

The study will also look at how well patients respond to the treatment and how it affects their overall survival. This includes tracking the time from the start of the study to any recurrence of cancer or death. The safety of Dostarlimab will be closely monitored, including any adverse effects that might lead to stopping the treatment or affect the patient's ability to undergo surgery. The study aims to provide valuable information on the effectiveness and safety of Dostarlimab as a treatment option for this type of colon cancer.

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

    Initial assessment

    The trial begins with an initial assessment to confirm eligibility. This includes a review of medical history and a physical examination.

    Blood and tissue samples are collected for analysis. These samples are used to understand the molecular and biological characteristics of the cancer.

  2. Step 2

    Treatment with dostarlimab

    The treatment phase involves the administration of dostarlimab, a medication given as an intravenous infusion.

    The dosage is 500 mg, and it is administered as a solution for infusion. The frequency and duration of administration are determined by the study protocol.

  3. Step 3

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and to identify any side effects.

    This includes blood tests and imaging studies to evaluate the cancer's response to the treatment.

  4. Step 4

    Surgery

    If the cancer is deemed resectable, surgery is performed to remove the tumor.

    The timing of the surgery is based on the response to the treatment with dostarlimab.

  5. Step 5

    Post-surgery evaluation

    After surgery, further evaluations are conducted to assess the success of the treatment and surgery.

    This includes additional blood and tissue sample analysis to understand the changes in the cancer at a molecular level.

  6. Step 6

    Long-term follow-up

    Long-term follow-up is conducted to monitor for any recurrence of cancer and to assess overall survival.

    This phase includes regular check-ups and may continue for several years after the initial treatment.

Who can join the trial?

11 criteria

  • The patient must have **untreated colon adenocarcinoma**, which is a type of colon cancer confirmed by a pathologist.
  • The patient should have an **ECOG performance status** of 0-1, which means they are fully active or have some symptoms but do not need bed rest during the day.
  • The patient must have **adequate bone marrow, kidney, and liver function**, and their blood should clot properly to safely receive the treatment.
  • The cancer should be **clinically staged** as cT3-4, cN0-2, cM0, or stage III, which describes the size and spread of the cancer.
  • The primary tumor must be **resectable**, meaning it can be surgically removed, and the patient should be fit for surgery.
  • The patient must have **MMR-p by IHC** or not be **MSI-H by PCR**, which are specific tests related to the cancer's genetic characteristics.
  • The patient or their legal representative must provide **voluntary written informed consent** before any screening procedures. They must agree to provide tumor tissue from colonoscopies and surgery, as well as necessary blood samples.
  • **Tumor and normal tissue samples** from biopsies must be available, collected during a standard diagnostic colonoscopy or a repeat colonoscopy. **Cytological specimens** like fine needle aspirates are not acceptable.
  • The patient must be **at least 18 years old** at the time of signing the informed consent.
  • The patient must use **highly effective birth control methods** during the trial and for 120 days after the last dose of treatment. These methods include implants, injectables, oral contraceptives, certain IUDs, true sexual abstinence, or having a partner who has had a vasectomy.
  • If the patient is a **woman of childbearing potential**, she must have a **negative pregnancy test** within 24 hours before the first dose of the study treatment.

Who cannot join the trial?

6 criteria

  • Participants with any other type of cancer besides **pMMR/MSS resectable colon cancer** cannot join. **pMMR/MSS** refers to a specific type of colon cancer that can be surgically removed.
  • Individuals who have already received treatment for their colon cancer are not eligible. The study is for those who have not yet been treated.
  • People with health conditions that might interfere with the study or its results may be excluded. This is to ensure the safety of participants and the accuracy of the study.
  • Participants must be within a certain age range, typically adults, to be eligible. This is to ensure the study results are applicable to the intended age group.
  • Both men and women can participate, but certain health conditions specific to gender may affect eligibility.
  • Individuals who are considered part of a vulnerable population, such as those unable to give informed consent, are not eligible to participate. This is to protect those who may not fully understand the study or its risks.
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Investigated drugs

Dostarlimab is a medication being studied for its potential use in treating colon cancer. In this trial, it is given to patients before surgery to see how it affects the cancer at a molecular level. The goal is to understand how the medication works in the body and to gather data that could help in developing future treatments for colon cancer.

What is already known about the treatment

Dostarlimab – Dostarlimab is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials, particularly for its effects on colon cancer that is resectable and has specific genetic characteristics (pMMR/MSS). The main therapeutic indication for Dostarlimab in this context is as a neoadjuvant treatment, which means it is given before the main treatment to help shrink the tumor. At the molecular level, Dostarlimab works by blocking a protein called PD-1, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor, a type of drug that helps the body's immune system fight cancer.

Investigated diseases

Colon Cancer – Colon cancer is a type of cancer that begins in the large intestine, which is the final part of the digestive tract. It often starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon. Over time, some of these polyps can become cancerous. The disease can progress through various stages, starting from localized growths to spreading to nearby lymph nodes and other organs. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. Early stages may not present noticeable symptoms, making regular screenings important for detection.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512499-36-00Estimated enrolment10 patientsSponsorUZ Leuven

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