Colorectal Cancer MetastaticCORESIMNCT06353854
Prospective National Cohort Evaluating Predictive Biomarkers of Resistance to Immunotherapy in Patients With MSI/dMMR Metastatic Colorectal Cancer (CORESIM)
An observational study of Colorectal Cancer Metastatic and Microsatellite Instability-High Colorectal Cancer, run by Federation Francophone de Cancerologie Digestive at 20 sites in France.
Trial summary
The Keynote 117 phase III trial demonstrated the superiority of pembrolizumab (anti-PD1 monoclonal antibody) versus chemotherapy +/- targeted therapy in first-line treatment of dMMR/MSI metastatic colorectal cancer (mCRC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic, Microsatellite Instability-High Colorectal Cancer
- How many people
- 600 participants
- Where
- 20 sitesFrance
- Study dates
- 12 Feb 2024to 12 Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
France20 sites, 20 recruiting
- Not yet recruiting
Ch - Centre Hospitalier de La Côte Basque
Bayonne, 64100
Franck AUDEMAR, Dr, +33 5 59 44 37 22, faudemar@ch-cotebasque.fr
Anne GUILNGAR, Dr, +33 5 59 44 37 22, aguilngar@ch-cotebasque.fr
- Not yet recruiting
Ch - Ch Beauvais
Beauvais
Fayçal HOCINE, 03 44 11 23 09, f.hocine@ch-beauvais.fr ; fayoncologie@yahoo.fr
- Not yet recruiting
CH Jean Minjoz
Besançon, 25030
Stéfano KIM, Dr, alrollin@chu-besancon.fr
- Recruiting
Polyclinique Saint Privat
Boujan-sur-Libron, 34760
Michaël HUMMELSBERGER, Dr, michael.hummelsberger@orange.fr
- Not yet recruiting
Ch - Duchenne
Boulogne-sur-Mer
Vincent BOURGEOIS, 06 84 88 43 37, vincebourgeois@hotmail.com
Vincent BOURGEOIS
- Not yet recruiting
Ch - Centre Hospitalier Metropole Savoie
Chambéry, 73011
Olivier BERTHELET, Dr, 0479965087, olivier.berthelet@ch-metropole-savoie.fr
Tarik HABET, Arc Étude, 0479965910, tarik.habet@ch-metropole-savoie.fr
- Not yet recruiting
Ch - Centre Hospitalier de Cholet
Cholet, 49300
You-Heng LAM, Dr, 02 41 49 66 79, you-heng.lam@ch-cholet.fr
Laura VALLEE, Arc Étude, 02 41 49 69 91, laura.vallee@ch-cholet.fr
- Not yet recruiting
CH - Compiegne
Compiègne
Virginie SEBBAGH, 0344236278, v.sebbagh@compiegnenoyon.fr
Virginie SEBBAGH
- Not yet recruiting
Ch - Chd Vendée
La Roche-sur-Yon, 85925
Margot LALY, Dr, +33 2 51 44 61 68, margot.laly@chd-vendee.fr
Paul GIROT, Dr, +33 2 51 44 61 68, paul.girot@chd-vendee.fr
- Not yet recruiting
CH - Louis Pasteur
Le Coudray
Sylvie APRELON, 0237303030, saprelon@ch-chartres.fr
- Recruiting
Centre Hospitalier Regional et Universitaire de Lille
Lille, 59037
ANTONY TURPIN, MD, 0320445461
- Not yet recruiting
CH Saint Joseph - Saint Luc
Lyon, 69365
Denis PERE VERGE, Dr, dpereverge@ch-stjoseph-stluc-lyon.fr; fannydenis@sfr.fr
- Not yet recruiting
Caluire et Cuire - Infirmerie Protestante de Lyon
Lyon
Johannes HARTWIG, johannes.hartwig@infirmerie-protestante.com
Johannes HARTWIG
- Not yet recruiting
Ch - Hôpital Saint Joseph
Marseille, 13285
Hervé PERRIER, Dr, 0491808211, hperrier@hopital-saint-joseph.fr
Christelle BASTHISTE-PELE, Dr, 0491808203, cbasthiste@hopital-saint-joseph.fr
- Not yet recruiting
CH Saint Joseph
Marseille
Hervé PERRIER, recherche-clinique@infirmerie-protestante.com; herve.perrier@infirmerie-protestante.com
Hervé PERRIER
- Not yet recruiting
Centre Hospitalier
Mulhouse, 68070
D. B. Vedrenne, MD, 33-3-8964-7049
- Not yet recruiting
CHR D'Orleans - Hopital de la Source
Orléans, 45100
Jean-Paul Lagasse, 33-02-3651-4704
- Recruiting
Prive - Institut Montsouris
Paris
Raphael COLLE, 0156616035, raphael.colle@imm.fr
Emilie SOULARUE, 0633312811, emilie.solarue@aphp.fr
- Not yet recruiting
Ch - Centre Hospitalier de Soisson
Soissons, 02209
Sarah MONTEMBAULT, Dr, 0326966859, sarah.montembault@ch-soissons.fr
Valérie PANIS, Arc Étude, 0322824002, paris.valerie@chu-amiens.fr
- Not yet recruiting
CH - Gustave Dron
Tourcoing
Loïc LEBELLEC, 0320694488, llebellec@ch-tourcoing.fr
Floriane RICHA, 0320694949, fverhaeghe@ch-tourcoing.fr
About this study
Official title: National French Cohort Evaluating Predictive Factors of Resistance to Immunotherapy in Patients With MSI Metastatic Colorectal Cancer
The Keynote 117 phase III trial demonstrated the superiority of pembrolizumab (anti-PD1 monoclonal antibody) versus chemotherapy +/- targeted therapy in first-line treatment of dMMR/MSI metastatic colorectal cancer (mCRC). However, primary resistance to pembrolizumab was observed in approximately 20-30% of patients treated in the Keynote 177 study. Therefore, the identification of biomarkers predictive of resistance to immunotherapy for dMMR/MSI mCRC is necessary to better select patients who benefit the most from immunotherapy, and those for whom other therapeutic approaches should be favored.
Read the detailed description
The primary endpoint is the identification of predictive factors of resistance to pembrolizumab in first-line treatment of MSI and/or dMMR metastatic colorectal cancer
CORESIM is a retrospective and prospective multicenter national French cohort. National recruitment will be carried out in all French centers, including the FFCD, AGEO, GERCOR, and UNICANCER, representing more than 150 centers and most French sites, public and private hospitals.
In France, pembrolizumab for first-line treatment of patients with MSI mCRC was accessible via its compassionate use in February 2021, then its reimbursement was effective in June 2023 Patients treated with pembrolizumab will be included prospectively on the start date of the study, i.e. on February 2024; patients treated since February 2021 via compassionate use of pembrolizumab will be included retrospectively A total of 600 patients are expected. The theoretical duration of inclusion is set at 2 years. All patients will be followed up for 3 years.
- Keywords
- immunotherapy resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective group | Registration of patients treated with pembrolizumab since February 2021. Collection of tumour sample archives will be associated | |
| Prospective group | Recruitment of metastatic colorectal cancer patients with microsatellite instability prior to the first administration of pembrolizumab immunotherapy. Blood and tumour sampling will be combined. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of predictive factors of resistance to pembrolizumab in first-line treatment of MSI and/or dMMR metastatic colorectal cancer
Primary resistance will be defined as immediate progression of the disease (at the time of the first assessment, excluding pseudoprogression) Secondary resistance will be defined as progression occurring after control of the disease.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start12 Feb 2024
- Primary completion12 Feb 2029 (estimated)
- Study completion12 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federation Francophone de Cancerologie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aziz ZAANAN, MD, PhD, Principal investigator, Hôpital Européen Georges Pompidou APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353854
- Sponsor's protocol ID
- FFCD 2112-CORESIM
- Acronym
- CORESIM
- Status last verified
- Oct 2025
- First submitted
- 28 Mar 2024
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National French Cohort Evaluating Predictive Factors of Resistance to Immunotherapy in Patients With MSI Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06353854
- Acronym / sponsor ID
- CORESIM / FFCD 2112-CORESIM
- Keywords
- immunotherapy resistance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Federation Francophone de Cancerologie DigestiveUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 12 Feb 2029 (estimated)
- Study completion
- 12 Feb 2030 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Keynote 117 phase III trial demonstrated the superiority of pembrolizumab (anti-PD1 monoclonal antibody) versus chemotherapy +/- targeted therapy in first-line treatment of dMMR/MSI metastatic colorectal cancer (mCRC). However, primary resistance to pembrolizumab was observed in approximately 20-30% of patients treated in the Keynote 177 study. Therefore, the identification of biomarkers predictive of resistance to immunotherapy for dMMR/MSI mCRC is necessary to better select patients who benefit the most from immunotherapy, and those for whom other therapeutic approaches should be favored.
Detailed description
The primary endpoint is the identification of predictive factors of resistance to pembrolizumab in first-line treatment of MSI and/or dMMR metastatic colorectal cancer
CORESIM is a retrospective and prospective multicenter national French cohort. National recruitment will be carried out in all French centers, including the FFCD, AGEO, GERCOR, and UNICANCER, representing more than 150 centers and most French sites, public and private hospitals.
In France, pembrolizumab for first-line treatment of patients with MSI mCRC was accessible via its compassionate use in February 2021, then its reimbursement was effective in June 2023 Patients treated with pembrolizumab will be included prospectively on the start date of the study, i.e. on February 2024; patients treated since February 2021 via compassionate use of pembrolizumab will be included retrospectively A total of 600 patients are expected. The theoretical duration of inclusion is set at 2 years. All patients will be followed up for 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective group | – | –Registration of patients treated with pembrolizumab since February 2021. Collection of tumour sample archives will be associated |
| Prospective group | – | –Recruitment of metastatic colorectal cancer patients with microsatellite instability prior to the first administration of pembrolizumab immunotherapy. Blood and tumour sampling will be combined. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of predictive factors of resistance to pembrolizumab in first-line treatment of MSI and/or dMMR metastatic colorectal cancer
Time frame: 2 years
Primary resistance will be defined as immediate progression of the disease (at the time of the first assessment, excluding pseudoprogression) Secondary resistance will be defined as progression occurring after control of the disease.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aziz ZAANAN, MD, PhD principal investigator
Hôpital Européen Georges Pompidou APHP
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Metastatic and Microsatellite Instability-High Colorectal Cancer, run by Federation Francophone de Cancerologie Digestive at 20 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aziz ZAANAN, MD, PhD (03 80 66 80 13, aziz.zaanan@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of predictive factors of resistance to pembrolizumab in first-line treatment of MSI and/or dMMR metastatic colorectal cancer (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.