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West Cancer Center
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COLORECTAL: METASTATIC: 1ST LINE: BRAF MT: BREAKWATER

An open-label, multicenter, randomized Phase 3 study of first-line encorafenib plus cetuximab with or without chemotherapy versus standard of care therapy with a safety lead-in of encorafenib and cetuximab plus chemotherapy in participants with metastatic BRAF V600E-mutant colorectal cancer

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Colon, Rectum, Colorectal

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Investigational Agent

Encorafenib, cetuximab

Drug Class

BRAF inhibitor, EGFR antibody

PI

Sponsor

Pfizer

Path

Key Eligibility Criteria Details
  • Age 16 or greater
  • Histologically or cytologically confirmed Stage IV CRC
  • Must contain a BRAF V600E mutation on local (FMI or Caris) or central testing
  • No prior systemic treatment in metastatic setting
  • Prior adjuvant or neoadjuvant therapy is OK only if relapse/metastasis is 6 months or greater from the end of the neo/adjuvant treatment
  • No history of acute or chronic pancreatitis
  • No symptomatic brain mets
  • Must have measurable disease
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