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

Title
Pfizer C4221015 (BRAF mt CRC, BREAKWATER)
Study Title

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

Site Link
Malignancy
Colon, Rectum, Colorectal
Stage
Disease Setting
Line Of Therapy
Investigational Agent
Encorafenib, cetuximab
Drug Class
BRAF inhibitor, EGFR antibody
PI
Axel Grothey, MD
Sponsor
Pfizer
Phase
Status
Key Eligibility Criteria
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
Objective
  • Primary
    • OS
  • Secondary
    • ORR
    • DoR
    • TTR
    • PFS
    • PFS2
    • Safety
    • QOL
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
X