OncoMatch/Clinical Trials/NCT05706779
Encorafenib Plus Cetuximab in a Neoadjuvant Setting in Patients With BRAF Mutation Localised Colon or Upper Rectum Cancer
Is NCT05706779 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Encorafenib Oral Capsule + Cetuximab for colorectal cancer.
Treatment: Encorafenib Oral Capsule + Cetuximab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: BRAF V600E
mutated BRAF V600E determined in a biopsy specimen
Excluded: KRAS mutation
known RAS mutation
Excluded: NRAS mutation
known RAS mutation
Disease stage
Required: Stage LOCALISED, RT3 WITH ≥ 5 MM EXTRA-MURAL EXTENSION, RT4 (rTNM)
localised, resectable after CT-scan assessment; Tumour stage rT4 or rT3 with ≥ 5 mm extra-mural extension in a CT-scan; Existence of distant metastases or adjacent nodules of peritoneal carcinosis (M1) [excluded]
Performance status
WHO 0–1
Prior therapy
Cannot have received: BRAF inhibitor
Previous treatment with a BRAF inhibitor
Cannot have received: anti-EGFR treatment (cetuximab)
Previous treatment with cetuximab or other anti-EGFR treatment
Lab requirements
Blood counts
Polymorphonuclear neutrophils (PMN) ≥ 1,500/mm3; Platelets ≥ 100,000/mm3; Hb ≥ 9g/dL
Kidney function
Creatinine clearance > 50 mL/min (according to MDRD formula)
Liver function
Total serum bilirubin ≤ 25 μmol/L, ALT and/or AST ≤ 2.5 x ULN
Cardiac function
QTcF ≤ 480 ms; cardiac function considered satisfactory
Haematological function considered satisfactory: PMN ≥ 1,500/mm3; Platelets ≥ 100,000/mm3; Hb ≥ 9g/dL; Creatinine clearance > 50 mL/min; Serum magnesium within normal limits; Total serum bilirubin ≤ 25 μmol/L, ALT and/or AST ≤ 2.5 x ULN; QTcF ≤ 480 ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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