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New treatment option for Colorectal Cancer
Official title Encorafenib Plus Cetuximab in a Neoadjuvant Setting in Patients With BRAF Mutation Localised Colon or Upper Rectum Cancer
ClinicalTrials.gov ID: NCT05706779
What this study is testing
What is Encorafenib Oral Capsule + Cetuximab?
Encorafenib Oral Capsule + Cetuximab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Informed consent signed and dated by the patient and the investigator
- Age ≥18 years at time of informed consent
- Adenocarcinoma of the colon or of the upper rectum (supra-peritoneal) considered operable and histologically confirmed, localised, mutated BRAF V600E...
- Tumour stage rT4 or rT3 with ≥ 5 mm extra-mural extension in a CT-scan.
- rT3 with high risk: Tumour spread from the peripheral serosa and extension to the adjacent peritoneal fat of more than 5 mm in its longest diameter...
You likely can't join if
- Existence of distant metastases or adjacent nodules of peritoneal carcinosis (M1).
- Existence of a dual-tumour location.
- known RAS mutation
- Peritonitis (secondary to perforation of the tumour) or symptomatic colonic occlusion or a temporary colostomy to prevent a sub-occlusion.
- Patient in whom an indication for radiotherapy exists based on the multidisciplinary meeting/board pre-operatively.
- Previous treatment with a BRAF inhibitor, cetuximab or other anti-EGFR treatment.
See the full eligibility criteria
Who can join
- Informed consent signed and dated by the patient and the investigator
- Age ≥18 years at time of informed consent
- Adenocarcinoma of the colon or of the upper rectum (supra-peritoneal) considered operable and histologically confirmed, localised, mutated BRAF V600E determined in a biopsy specimen and resectable after CT-scan...
- Tumour stage rT4 or rT3 with ≥ 5 mm extra-mural extension in a CT-scan.
- rT3 with high risk: Tumour spread from the peripheral serosa and extension to the adjacent peritoneal fat of more than 5 mm in its longest diameter (both axial and coronal planes)
- rT4: Extension to an adjacent organ
- Patient able to provide a sufficient quantity of representative tumour sample (slides or extracted tumor DNA) for centralised analysis of RAS and BRAF mutational status.
- WHO performance status 0 or 1
- Haematological function considered satisfactory:
- Polymorphonuclear neutrophils (PMN) ≥ 1,500/mm3
- Platelets ≥ 100,000/mm3
- Hb ≥ 9g/dL
- Creatinine clearance \> 50 mL/min (according to MDRD formula).
- Serum levels of magnesium within normal limits of the centre.
- Total serum bilirubin ≤ 25 μmol/L, ALT and/or AST ≤ 2.5 x ULN.
- Cardiac function considered satisfactory: o Corrected mean QT interval for heart rate according to the Fridericia formula (QTcF) ≤ 480 ms.
- Patient able to take medicinal products by mouth (OD).
- Female Patients postmenopausal for at least one year or surgically infertile for at least 6 weeks, or effective contraception for male and female patients of childbearing potential for 2 months after the end of the...
- A negative pregnancy test for inclusion for all female patients of child-bearing FFCD 2006 - NEORAF Version 1.0- 21/October2022 Page 7 of 69 potential.
- Patient covered by a plan of the French Social Security system
What rules you out
- Existence of distant metastases or adjacent nodules of peritoneal carcinosis (M1).
- Existence of a dual-tumour location.
- known RAS mutation
- Peritonitis (secondary to perforation of the tumour) or symptomatic colonic occlusion or a temporary colostomy to prevent a sub-occlusion.
- Patient in whom an indication for radiotherapy exists based on 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 (with immuno-modulators or immuno-suppressants) ≤ 12 months before start of study treatment.
- Patient with decreased cardiovascular function or clinically significant cardiovascular disease:
- 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.
- Symptomatic congestive heart failure (CHF) (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...
- Child-Pugh class B or C cirrhosis.
- Deterioration of gastro-intestinal function or a disease which may significantly impair the absorption of encorafenib, e.g.: ulcer disease, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, small bowel...
- A previous or concomitant malignant tumour within 5 years prior to the study. Except for basal cell or squamous skin cancer, superficial cancer of the bladder, intra-epithelial carcinoma of the prostate, carcinoma in...
- A concomitant neuro-muscular disease associated with high levels of creatinine kinase (CK). Remark: inflammatory muscular disease, muscular dystrophy, amyotrophic lateral sclerosis (ALS), spinal muscular atrophy.
- History of infection with human immunodeficiency virus (HIV).
- Active infection with hepatitis B or hepatitis C.
- Known existence of Gilbert syndrome
- 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.
- 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...
- Persons who are deprived of their freedom or who are under guardianship
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.