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Why does immunotherapy fail in some bowel cancer patients? new study aims to find out

NCT ID NCT06353854

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will follow 600 people with a specific type of advanced colorectal cancer (MSI-high) who are being treated with the immunotherapy drug pembrolizumab. The goal is to understand why about 20-30% of patients do not respond to this treatment. By analyzing tumor samples and patient data, researchers hope to identify markers that predict resistance, helping to personalize treatment decisions in the future.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pembrolizumab
What this could lead to
If successful, this could help doctors identify which patients are unlikely to benefit from pembrolizumab, allowing them to choose alternative treatments earlier.
What could go wrong
This is an observational study, not a treatment trial. It will not directly improve outcomes for participants, and the findings may not lead to immediate changes in care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Prospective inclusion of patients receiving first-line immunotherapy with pembrolizumab (as defined in the MA) for unresectable mCRC. Patients who have received pembrolizumab in the same indication on a compassionate basis since February 2021 may also be retrospectively included in the cohort.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients over 18 years old * Histologically confirmed colorectal adenocarcinoma with unresectable metastasis(s) receiving immunotherapy as first-line treatment with pembrolizumab * Tumor with microsatellite instability determined by immunohistochemistry (loss of expression of MLH1, MSH2, MSH6 and/or PMS2) and/or by molecular biology (MSI-H on microsatellite analysis from tumor DNA according to practice routine of the center) Exclusion Criteria: * Patients with another concomitant cancer at the time of diagnosis requiring systemic treatment or impacting prognosis according to the medical team. * Previous treatment with anti-PD1 or anti-PDL1. * Previous treatment with chemotherapy +/- targeted therapy for MSI/dMMR metastatic colorectal cancer. * Contraindication due to psychological or social reasons that may hinder follow-up (cognitive deficit, psychological disorders incompatible with obtaining non-opposition or consent; inability to be followed in the same center throughout the follow-up period for geographical reasons). * Pregnant women * persons under court protection or under protective supervision (guardianship or curatorship) * Opposition to participation in the study.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CH - Compiegne

    NOT_YET_RECRUITING

    Compiègne, France

  • CH - Gustave Dron

    NOT_YET_RECRUITING

    Tourcoing, France

  • CH - Louis Pasteur

    NOT_YET_RECRUITING

    Le Coudray, France

  • CH Jean Minjoz

    NOT_YET_RECRUITING

    Besançon, 25030, France

  • CH Saint Joseph

    NOT_YET_RECRUITING

    Marseille, France

  • CH Saint Joseph - Saint Luc

    NOT_YET_RECRUITING

    Lyon, 69365, France

  • CHR D'Orleans - Hopital de la Source

    NOT_YET_RECRUITING

    Orléans, 45100, France

  • Caluire et Cuire - Infirmerie Protestante de Lyon

    NOT_YET_RECRUITING

    Lyon, France

  • Centre Hospitalier

    NOT_YET_RECRUITING

    Mulhouse, 68070, France

  • Centre Hospitalier Regional et Universitaire de Lille

    RECRUITING

    Lille, 59037, France

  • Ch - Centre Hospitalier Metropole Savoie

    NOT_YET_RECRUITING

    Chambéry, 73011, France

  • Ch - Centre Hospitalier de Cholet

    NOT_YET_RECRUITING

    Cholet, 49300, France

  • Ch - Centre Hospitalier de La Côte Basque

    NOT_YET_RECRUITING

    Bayonne, 64100, France

  • Ch - Centre Hospitalier de Soisson

    NOT_YET_RECRUITING

    Soissons, 02209, France

  • Ch - Ch Beauvais

    NOT_YET_RECRUITING

    Beauvais, France

  • Ch - Chd Vendée

    NOT_YET_RECRUITING

    La Roche-sur-Yon, 85925, France

  • Ch - Duchenne

    NOT_YET_RECRUITING

    Boulogne-sur-Mer, France

  • Ch - Hôpital Saint Joseph

    NOT_YET_RECRUITING

    Marseille, 13285, France

  • Polyclinique Saint Privat

    RECRUITING

    Boujan-sur-Libron, 34760, France

  • Prive - Institut Montsouris

    RECRUITING

    Paris, France

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