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A Clinical-biological Prospec...

A Clinical-biological Prospective Cohort of Patients With BRAFV600E-mutated Metastatic Colorectal Cancer

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-24

Study Completion Date

2028-07-31

Brief Summary

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The study will be conducted in patients with metastatic colorectal cancer (mCRC) harboring a BRAFV600E mutation, to collect clinical data and biological samples to be used for research but also to gather real-world clinical data concerning the treatments and the survival outcomes in patients with this pathology.

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Detailed Description

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Despite substantial progress made in the first- and second line mCRC settings, there are still unmet clinical needs for patients harboring BRAFV600E mutations, especially those with microsatellite stability (MSS) / proficient mismatch repair (pMMR) tumor. The overall survival and access to different treatment in the real-life setting are unknown. Moreover, patient prognosis remains poor and therapeutic resistance to combinations with BRAF inhibitors, is at present, nearly universal. Therefore, it seems essential to prospectively collect clinical and biological data about this rare mCRC subtype. These data will allow us to improve knowledge and to identify clinical and biological factors that could drive therapeutic decisions, predict resistance to treatments, and that are prognostic for survival. In this context, we designed this large, prospective, cohort study to collect clinical data and biological samples to be used for research but also to gather real-world clinical data concerning the treatments and the survival outcomes in patients with BRAFV600E mCRC.

This collection of clinical and biological data (tumor tissue and blood samples) will allow us to identify predictive and prognostic biomarkers with several research work packages planned:

i. To evaluate the circulating tumor DNA (ctDNA) during the metastatic first-, second-, and third-line treatment to:

* Evaluate its positive and negative predictive value.
* Identify molecular alterations preceding and explaining clinical resistance during BRAF/EGFR inhibition therapy and immunotherapy.

ii. To evaluate BRAFV600E mCRC immune environment both at the tumor and blood level (immunomonitoring).

iii. To study specific the dMMR/MSI BRAFV600E subgroup. Furthermore, the data collected will describe the therapeutic management of BRAFV600E mCRC patients in the routine-practice setting which will bring very useful data. The results of the COBRAF study could lay the groundwork to better understand BRAFV600E mCRC and to identify prognostic and predictive biomarkers helping the development of new therapeutic approaches in this population.

Conditions

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Metastatic Colorectal Cancer BRAF V600E Mutation Positive

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

The COBRAF study was designed as a prospective, multicenter, study. The study is without a therapeutic intervention and is of minimal risk and constraints (category 2 according to the "Loi Jardé"). The study will be conducted in patients with mCRC harboring a BRAFV600E mutation.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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COBRAF

A 30 mL blood samples (6 mL in each of 5 EDTA tubes) will be collected from each patient at the following timepoints:

* At the starts of cycle 1, 2 and 3,
* At 3 and 6 months after starting of each treatment line, if applicable.
* At disease progression after second-line treatment with encorafenib combined with cetuximab, if applicable.
* At disease progression after immunotherapy-based treatment in dMMR/MSI patients.

At most 390 mL of blood will be collected from each patient during the study.

Group Type OTHER

Collection of blood samples

Intervention Type OTHER

A 30 mL blood samples (6 mL in each of 5 EDTA tubes) will be collected from each patient at each timepoint.

Interventions

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Collection of blood samples

A 30 mL blood samples (6 mL in each of 5 EDTA tubes) will be collected from each patient at each timepoint.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Men and women aged 18 years or older
2. Histologically confirmed BRAFV600E metastatic colorectal cancer (mCRC), chemotherapy-naive in the metastatic setting or having initiated a first line of chemotherapy in the metastatic setting (except encorafenib-cetuximab treatment)
3. Available tumor tissue sample obtained before inclusion with sufficient tissue left for biological studies. Patients with only fine-needle aspirations are not eligible.
4. Known MMR/microsatellite status (immunohistochemistry \[IHC\] and polymerase chain reaction \[PCR\]) (or under analysis)
5. Patients must have signed a written informed consent form prior to any trial specific procedures. If the patients are physically unable to give their written consent, a trusted person of their choice, not related to the investigator or the sponsor, can confirm in writing the patient's consent.
6. Patients must be willing and able to comply with the study procedures
7. The patient must be affiliated to a social security system or benefit of such a system.

Exclusion Criteria

1. Patient with another cancer concomitantly with the mCRC requiring treatment or influencing the prognosis according to the medical staff.
2. Patients for whom the follow-up will not be assured by the investigator or its team.
3. Any condition that may jeopardize patient participation in the study as well as non-contraception for men and women with child-bearing potential, and pregnancy or breast feeding for women.
4. Persons deprived of their liberty or under protective custody or guardianship.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christelle DE LA FOUCHARDIERE, MD

Role: PRINCIPAL_INVESTIGATOR

CENTRE LEON BERARD - LYON

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France

Central Contacts

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Emilie BRUMENT

Role: CONTACT

[email protected]

+33(0)1 71 93 61 64

Anne-Sophie BACH, PHD

Role: CONTACT

[email protected]

+33(0)6 10 33 00 51

Facility Contacts

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Annie PEYTIER, MD

Role: primary

[email protected]

Lola-Jade PALMIERI, MD

Role: primary

[email protected]

+33(0)5 56 33 33 33

Slim LASSOUED, MD

Role: primary

[email protected]

Marine JARY, MD

Role: primary

[email protected]

+33(0)4 73 75 05 08

Elisabeth CAROLA, MD

Role: primary

Charlotte FENIOUX, MD

Role: primary

[email protected]

David SOLUB, MD

Role: primary

Role: primary

Christelle DE LA FOUCHARDIERE, MD

Role: primary

[email protected]

Role: primary

Faiza KHEMISSA, MD

Role: primary

[email protected]

04 68 61 89 01

David TOUGERON, MD

Role: primary

[email protected]

+33(0)5 49 44 37 51

Olivier BOUCHE, MD

Role: primary

[email protected]

+33(0)3 28 78 31 13

Role: primary

Romain CHAUTARD, MD

Role: primary

[email protected]

+33(0)2 47 47 75 78

Marie MULLER, MD

Role: primary

[email protected]

03 83 15 51 79

Edwige BAUDRY, MD

Role: primary

Valentine DISDERO, MD

Role: primary

Other Identifiers

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2022-A02232-41

Identifier Type: OTHER

Identifier Source: secondary_id

UC-GIG-2210/PRODIGE75

Identifier Type: -

Identifier Source: org_study_id

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A Clinical-biological Prospective Cohort of Patients With BRAFV600E-mutated Metastatic Colorectal Cancer

Study Results

Basic Information

Brief Summary

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Detailed Description

Conditions

Study Design

Study Groups

COBRAF

Collection of blood samples

Interventions

Collection of blood samples

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Pierre Fabre Medicament

UNICANCER

Responsible Party

Principal Investigators

Christelle DE LA FOUCHARDIERE, MD

Locations

Centre Hospitalier D'Avignon

Centre Hospitalier de Bayeux

Chu Simone Veil

Institut Bergonie

CH Fleyriat

Ch de Cahors

CH Dr TECHER

Infirmerie Protestante de Lyon

Chu Estaing de Clermont-Ferrand

GHPSO

Aphp - Hopital Henri Mondor

Groupe Hospitalier Mutualiste de Grenoble

Chu de Grenoble Alpes - Hopital Michallon

CH Louis Pasteur

Groupe Hospitalier Emile Roux

Hopital Franco-Britannique

Chu Dupuytren

Centre Leon Berard

Hôpital privé Jean Mermoz

Hopital de La Timone

Intitut Paoli Calmettes

Grand Hopital de L'Est Francilien - Site de Meaux

Centre Antoine Lacassagne

CHR d'Orléans

Aphp - Hopital Saint Louis

Hopital Saint Antoine

Aphp - Hopital Bichat

Aphp - La Pitie Salpetriere

Institut Mutualiste Montsouris

Gh Diaconesses Croix Saint Simon

Hopital Europeen Georges Pompidou

Ch Perpignan

Chu Poitiers

Chu de Reims

Chu Rennes Pontchaillou

Chu de Rouen

Hôpital Privé de la Loire

Hnia Begin

Ch de Saint Malo

Centre Paul Strauss

Hnia Saint Anne

Chu de Tours

Chru de Nancy

Institut de Cancerologie de Lorraine

Centre d'Oncologie Saint Yves

Countries

Central Contacts

Emilie BRUMENT

Anne-Sophie BACH, PHD

Facility Contacts

Annie PEYTIER, MD

Lola-Jade PALMIERI, MD