Study to Evaluate the Efficacy and Safety of Cetuximab in Combination with Encorafenib Plus Binimetinib As Induction Treatment in BRAF V600E Mutated MSS Initially Resectable or Potentially Resectable Advanced Colorectal Cancer

As a result of the little benefit obtained from standard treatments and the poor prognosis of these patients, the BRAF-V600E mutant MSS aCRC represents an unmet medical need requiring clinical research. The combination of encorafenib, cetuximab and binimetinib as second- or third-line treatment for mCRC resulted in significantly better outcomes than standard therapy in a phase 3 clinical trial, which also revealed treatment safety and tolerability to be acceptable. Compared to the control group (cetuximab and irinotecan or cetuximab and FOLFIRI), the triplet therapy cohort showed higher media

Trial Details

NCT ID
NCT06207656
Phase
PHASE2
Sponsor
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • EBC
Locations (sample)
  • Madrid, Spain|40.4165,-3.70256

Key Eligibility Criteria

  • 1\. Male or female participants age ≥18 years at the time of informed consent. 2. Capable of giving signed informed consent/assent. 3. Participants…
  • 4\. Participants with histologically or cytologically confirmed colorectal adenocarcinoma.
  • 5\. Presence of a BRAF V600E mutation confirmed as per standard of care according to international guidelines at any time prior to Screening.
  • 6\. Microsatellite stable (MSS) or Mismatch-Repair proficient (pMMR) disease confirmation assessed by local PCR or immunohistochemistry (IHC).

For full eligibility, visit ClinicalTrials.gov.

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