Why does immunotherapy fail in some bowel cancer patients? new study aims to find out
NCT ID NCT06353854
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Colorectal cancer metastatic are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
20 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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_RECRUITINGCompiègne, France
-
CH - Gustave Dron
NOT_YET_RECRUITINGTourcoing, France
-
CH - Louis Pasteur
NOT_YET_RECRUITINGLe Coudray, France
-
CH Jean Minjoz
NOT_YET_RECRUITINGBesançon, 25030, France
-
CH Saint Joseph
NOT_YET_RECRUITINGMarseille, France
-
CH Saint Joseph - Saint Luc
NOT_YET_RECRUITINGLyon, 69365, France
-
CHR D'Orleans - Hopital de la Source
NOT_YET_RECRUITINGOrléans, 45100, France
-
Caluire et Cuire - Infirmerie Protestante de Lyon
NOT_YET_RECRUITINGLyon, France
-
Centre Hospitalier
NOT_YET_RECRUITINGMulhouse, 68070, France
-
Centre Hospitalier Regional et Universitaire de Lille
RECRUITINGLille, 59037, France
-
Ch - Centre Hospitalier Metropole Savoie
NOT_YET_RECRUITINGChambéry, 73011, France
-
Ch - Centre Hospitalier de Cholet
NOT_YET_RECRUITINGCholet, 49300, France
-
Ch - Centre Hospitalier de La Côte Basque
NOT_YET_RECRUITINGBayonne, 64100, France
-
Ch - Centre Hospitalier de Soisson
NOT_YET_RECRUITINGSoissons, 02209, France
-
Ch - Ch Beauvais
NOT_YET_RECRUITINGBeauvais, France
-
Ch - Chd Vendée
NOT_YET_RECRUITINGLa Roche-sur-Yon, 85925, France
-
Ch - Duchenne
NOT_YET_RECRUITINGBoulogne-sur-Mer, France
-
Ch - Hôpital Saint Joseph
NOT_YET_RECRUITINGMarseille, 13285, France
-
Polyclinique Saint Privat
RECRUITINGBoujan-sur-Libron, 34760, France
-
Prive - Institut Montsouris
RECRUITINGParis, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Watch and wait: could immunotherapy let some GI cancer patients avoid surgery?
- Can a smart drug home in on Hard-to-Treat cancers?
- Can a vaccine boost immunotherapy against a stubborn cancer?
- What does recovery really look like after aggressive peritoneal cancer surgery?
- Chemo holidays put to the test: can scheduled breaks beat continuous treatment for advanced colorectal cancer?
- Can two immune boosters outsmart Chemo-Resistant colon cancer?