Actively Recruiting
Combination of Encorafenib Plus Cetuximab in a Neoadjuvant Setting in Patients With Braf V600E-Mutated Localised Colon or Upper Rectum Cancer (Neoraf Study)
Led by Federation Francophone de Cancerologie Digestive · Updated on 2025-09-02
30
Participants Needed
1
Research Sites
126 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
Researchers are evaluating the combination of encorafenib and cetuximab as a pre-surgery treatment for patients with colon cancer or upper rectal cancer who have a specific BRAF V600E mutation. This pilot trial aims to study about 30 patients who have this mutation confirmed, focusing on the tumor's response to this targeted therapy before surgery. If a patient's tumor does not have the mutation or has a different mutation, their treatment will stop, and they will have surgery as soon as possible. The treatment involves taking encorafenib orally at a dose of 300 mg daily for six weeks, alongside intravenous infusions of cetuximab every two weeks for three cycles. The study includes a centralized confirmation of the tumor's mutation status during the first cycle. Patients with confirmed BRAF V600E mutation and no RAS mutations will continue treatment followed by surgery. Participants will be closely monitored through assessments including tumor staging by CT scan, blood tests, and performance status evaluations. The main measure of success is the rate of significant tumor shrinkage assessed about six months after enrollment. Safety monitoring and adherence to treatment will be ensured throughout the study period, with surgery organized after the neoadjuvant treatment phase. The total participation duration varies, depending on treatment and surgery timing.
CONDITIONS
Brief 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 by patient and investigator
- Age 18 years or older at consent
- Operable, localized adenocarcinoma of colon or upper rectum confirmed by biopsy with BRAF V600E mutation
- Tumor stage rT4 or rT3 with 5 mm or more extra-mural extension on CT scan
- Ability to provide tumor samples for central RAS and BRAF mutation analysis
- WHO performance status 0 or 1
- Adequate blood counts: neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL
- Creatinine clearance above 50 mL/min
- Normal serum magnesium levels
- Total bilirubin ≤ 25 µmol/L, ALT and/or AST ≤ 2.5 times upper limit
- Corrected QT interval ≤ 480 ms
- Ability to take oral medications
- Female patients postmenopausal for at least 1 year or surgically infertile for at least 6 weeks, or use effective contraception
- Negative pregnancy test for women of childbearing potential
- Covered by French Social Security plan
You will not qualify if you...
- Presence of distant metastases or peritoneal carcinomatosis nodules
- Dual-tumor locations
- Known RAS mutation
- Peritonitis or symptomatic colonic blockage or temporary colostomy
- Indication for preoperative radiotherapy
- Previous treatment with BRAF inhibitor, cetuximab, or anti-EGFR treatment
- History of acute or chronic pancreatitis within 6 months
- Chronic inflammatory bowel disease requiring immunosuppressive treatment within 12 months
- Significant cardiovascular disease or decreased function within 6 months
- Child-Pugh class B or C liver cirrhosis
- Gastrointestinal conditions impairing drug absorption
- Malignant tumors within 5 years except certain treated skin or bladder cancers
- Neuromuscular diseases with high creatinine kinase
- History of HIV infection
- Active hepatitis B or C infection
- Known Gilbert syndrome
- Use of strong CYP3A4/5 inducers or inhibitors within 1 week prior to treatment
- Severe hypersensitivity to monoclonal antibodies or BRAF inhibitors
- Participation in another clinical trial with investigational product within 4 weeks or 5 half-lives
- Persons deprived of freedom or under guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive oral Encorafenib capsules daily for 6 weeks and intravenous Cetuximab every 2 weeks for 3 cycles over 4 weeks.
3 visits (in-person) for Cetuximab infusions on Days 1, 14, and 28
Trial Site Locations
Total: 1 location
1
Chu - Hôpital Européen Georges Pompidou
Paris, France
Actively Recruiting
Research Team
P
Project Manager
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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