Actively Recruiting
Encorafenib Plus Cetuximab in a Neoadjuvant Setting in Patients With BRAF Mutation Localised Colon or Upper Rectum Cancer
Led by Federation Francophone de Cancerologie Digestive · Updated on 2025-09-02
30
Participants Needed
1
Research Sites
328 weeks
Total Duration
On this page
Sponsors
F
Federation Francophone de Cancerologie Digestive
Lead Sponsor
P
Pierre Fabre Laboratories
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a pilot trial which aims to assess the concept of anti-BRAF neoadjuvant treatment (encorafenib) in combination with cetuximab in patients with colon cancer or rT3/T4 supra-peritoneal upper rectal cancer based on a pre-operative CT-scan. About 10% of patients will have a mutated BRAF V600E tumour and the objective is to include 30 patients with this mutation. If the tumour is not confirmed as a carrier of the BRAF V600E mutation or has an RAS mutation according to centralised assessment, treatment will be discontinued in this patient and cancer surgery will be organised as soon as possible. The patient will be excluded from the statistical analysis and will be replaced by a new patient in order to obtain 30 patients with confirmed BRAF V600E mutation and RAS wild type . It should be noted that less than a 3% discrepancy between the numbers of local laboratory results and central analysis results, has been reported in over 600 BRAF V600E mutated colon cancers in the BEACON CRC study. Based on these figures, there should be 0 or 1 patient with discrepant results in the study presented here. Furthermore, in the hypothetical case of a patient who is an early permanent discontinuation of the study prior to surgery, this patient will be replaced in order to obtain a total of 30 patients who underwent surgery after neoadjuvant treatment.
CONDITIONS
Official Title
Encorafenib Plus Cetuximab in a Neoadjuvant Setting in Patients With BRAF Mutation Localised Colon or Upper Rectum Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 18 years or older
- Histologically confirmed operable adenocarcinoma of the colon or upper rectum with localized disease
- Confirmed BRAF V600E mutation in tumor biopsy
- Tumor stage rT4 or rT3 with 5 mm or more extra-mural extension on CT scan
- Ability to provide sufficient tumor sample for RAS and BRAF mutation analysis
- WHO performance status 0 or 1
- Satisfactory blood counts: PMN 600/mm3, platelets 100,000/mm3, hemoglobin 9 g/dL
- Creatinine clearance above 50 mL/min
- Normal serum magnesium levels
- Total bilirubin 25 bcmol/L, ALT and/or AST 2.5 times upper limit of normal
- Cardiac function with QTcF interval 480 ms
- Ability to take oral medication
- Females must be postmenopausal for at least one year, surgically infertile for 6 weeks, or use effective contraception
- Negative pregnancy test for women of childbearing potential
- Covered by French Social Security system
You will not qualify if you...
- Presence of distant metastases or peritoneal carcinomatosis nodules
- Dual tumor location
- Known RAS mutation
- Peritonitis or symptomatic colonic obstruction or temporary colostomy
- Indication for preoperative radiotherapy
- Previous treatment with BRAF inhibitor, cetuximab, or anti-EGFR therapy
- History of acute or chronic pancreatitis within 6 months
- Chronic inflammatory bowel disease requiring immune-modulating treatment within 12 months
- Significant cardiovascular disease or decreased function within 6 months
- Child-Pugh class B or C cirrhosis
- Gastrointestinal conditions impairing drug absorption
- Malignant tumors within 5 years (except certain non-invasive cancers)
- Neuromuscular diseases with high creatinine kinase
- HIV infection
- Active hepatitis B or C infection
- Known Gilbert syndrome
- Use of agents affecting CYP3A4/5 within 1 week before treatment
- Severe hypersensitivity to monoclonal antibodies or BRAF inhibitors, history of anaphylaxis, or uncontrolled asthma
- Participation in another clinical trial with investigational product recently
- Persons deprived of liberty or under guardianship
AI-Screening
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Trial Site Locations
Total: 1 location
1
Chu - Hôpital Européen Georges Pompidou
Paris, France
Actively Recruiting
Research Team
P
Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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