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FFCD 2006 – NEORAF : A MULTI-CENTRE, OPEN-LABEL, PILOT TRIAL EVALUATING THE COMBINATION ENCORAFENIB AND CETUXIMAB IN A NEOADJUVANT SETTING IN PATIENTS WITH BRAF V600E-MUTATED LOCALISED COLON OR UPPER RECTUM CANCER
EU CTIS ID: 2024-514107-34-00
What this study is testing
To assess, in patients with localized BRAFV600E mutated CRC treated with neoadjuvant encorafenib and cetuximab: safety and feasibility
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Informed consent dates and signed by the patient and the investigator
- Serum total bilirubin ≤ 25 μmol/L, ALT and/or AST ≤ 2.5 x ULN.
- Cardiac function considered satisfactory: o Mean QT interval corrected for heart rate according to Fridericia formula (QTcF) ≤ 480 msec.
- Patient able to take medicinal products by mouth.
- Female Patients postmenopausal for at least one year or surgically infertile for at least 6 weeks, or effective contraception (see paragraph 9.3.3 for more details) for male and female patients of childbearing potential for 2 months after the end of the investigational treatments
- A negative pregnancy test for inclusion in the study for all female patients of child-bearing potential. In case of a “urine pregnancy test”, it must be a highly sensitive urine pregnancy test, in accordance with the recommendations of the CTFG regarding pregnancy risk management (
You likely can't join if
- Existence of distant metastases or adjacent nodules of peritoneal carcinosis (M1).
- Known severe hypersensitivity reactions to monoclonal antibodies or BRAF-inhibitors (grade ≥ 3), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
- Participation in a clinical study with administration of an investigational product within 4 weeks or five times the half-life of the investigational product, according to the longest period, prior to the first dose of the study treatment.
- Existence of a dual-tumour location.
- Persons who are deprived of their freedom or who are under guardianship.
- Known RAS mutation
See the full eligibility criteria
Who can join
- Informed consent dates and signed by the patient and the investigator
- Serum total bilirubin ≤ 25 μmol/L, ALT and/or AST ≤ 2.5 x ULN.
- Cardiac function considered satisfactory: o Mean QT interval corrected for heart rate according to Fridericia formula (QTcF) ≤ 480 msec.
- Patient able to take medicinal products by mouth.
- Female Patients postmenopausal for at least one year or surgically infertile for at least 6 weeks, or effective contraception (see paragraph 9.3.3 for more details) for male and female patients of childbearing potential for 2 months after the end of the investigational treatments
- A negative pregnancy test for inclusion in the study for all female patients of child-bearing potential. In case of a “urine pregnancy test”, it must be a highly sensitive urine pregnancy test, in accordance with the recommendations of the CTFG regarding pregnancy risk management (
- Patient to be covered by a regimen of French Social Security system.
- Age ≥18 years at time of informed consent
- Adenocarcinoma of the colon or of the upper rectum (supra-peritoneal) considered operable, histologically confirmed, localised mutated BRAF V600E determined in a biopsy specimen and resectable after CT-scan assessment.
- Stage rT4 or rT3 tumour with ≥ 5 mm extra-mural extension in CT-scan.
- Be able to provide a sufficient quantity of representative tumour sample (slides or extracted tumor DNA) for centralised analysis of RAS and BRAF mutation status.
- WHO performance status 0 or 1
- Haematological function considered satisfactory: o Polymorphonuclear neutrophils (PMN) ≥ 1,500/mm3 o Platelets ≥ 100,000/mm3 o Hb ≥ 9g/dL
- Creatinine clearance > 50 mL/min (according to MDRD formula).
- Serum magnesium within normal limits of the centre.
What rules you out
- Existence of distant metastases or adjacent nodules of peritoneal carcinosis (M1).
- Known severe hypersensitivity reactions to monoclonal antibodies or BRAF-inhibitors (grade ≥ 3), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
- Participation in a clinical study with administration of an investigational product within 4 weeks or five times the half-life of the investigational product, according to the longest period, prior to the first dose of the study treatment.
- Existence of a dual-tumour location.
- Persons who are deprived of their freedom or who are under guardianship.
- Known RAS mutation
- Peritonitis (secondary to perforation of the tumour)
- Patient in whom an indication for radiotherapy is chosen by the multidisciplinary meeting/board pre-operatively.
- Previous treatment with a BRAF inhibitor, cetuximab or other anti-EGFR treatment.
- History of acute or chronic pancreatitis within the 6 months prior to start of the study treatment.
- A history of chronic inflammatory bowel disease requiring treatment (immuno-modulators or immuno-suppressants) ≤ 12 months before start of study treatment.
- Child-Pugh class B or C cirrhosis.
- Decreased cardiovascular function or clinically significant cardiovascular disease: o History of myocardial infarction, acute coronary syndrome (including unstable angina, coronary artery bypass grafting, coronary angioplasty or stent placement) ≤ 6 months prior to start of the study treatment. o Symptomatic congestive heart failure (grade 2 or higher), history or current evidence of cardiac arrhythmia and/or a clinically significant conduction disorder ≤ 6 months prior to start of the study treatment, except atrial fibrillation with controlled heart rate and paroxysmal supra-ventricular tachycardia.
- Colonic obstruction that has not been defunctioned* *Patients with symptomatic bowel obstruction cannot be included unless the obstruction has been relieved by defunctioning
- Decreased gastro-intestinal function or GI disease which may significantly deteriorate the absorption of encorafenib
- Previous or concomitant malignant tumour within 5 years prior to the study.
- A concomitant neuro-muscular disease associated with high level of creatinine kinase (CK).
- History of infection with human immunodeficiency virus (HIV).
- Active hepatitis B or hepatitis C infection.
- Known Gilbert syndrome or known genotypes such as UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28.
- Use of medicinal plants/dietary supplements or other medicinal products or foods that are potent inducing agents or inhibitors of cytochrome P450 (CYP) 3A4/5 ≤ 1 week before start of the study treatment.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.