Encorafenib Plus Cetuximab in a Neoadjuvant Setting in Patients With BRAF Mutation Localised Colon or Upper Rectum Cancer

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 poss

Trial Details

NCT ID
NCT05706779
Phase
PHASE2
Sponsor
Federation Francophone de Cancerologie Digestive
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • Encorafenib Oral Capsule + Cetuximab
Locations (sample)
  • Paris, France|48.85341,2.3488

Key Eligibility Criteria

  • 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 V60…
  • Remark: Centralised analysis of BRAF status will be performed in order to confirm the existence of the mutation concomitantly with the 1st cycle of…

For full eligibility, visit ClinicalTrials.gov.

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