COLORECTAL: METASTATIC: BRAF mt: 1st Line: ANCHOR

Phase II, Open-label, Single Arm, Multicenter Study of Encorafenib, Binimetinib Plus Cetuximab in Subjects With Previously Untreated BRAF V600E -Mutant Metastatic Colorectal Cancer

Title
Pierre Fabre W00090 GE 2 01 ANCHOR Colorectal BRAF mt
Study Title

Phase II, Open-label, Single Arm, Multicenter Study of Encorafenib, Binimetinib Plus Cetuximab in Subjects With Previously Untreated BRAF V600E -Mutant Metastatic Colorectal Cancer

Site Link
Malignancy
Colorectal cancer, colon cancer, rectum cancer
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st Line
Investigational Agent
Encorafenib, Binimetinib, Cetuximab
Drug Class
BRAF inhibitor, MEK inhibitor, EGFR antibody
PI
Axel Grothey, MD
Sponsor
Pierre Fabre Medicament
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Metastatic colorectal cancer
  • Presence of BRAF V600E mutation in tumor tissue determined by local assay at any time prior to screening
  • No prior therapy for metastatic disease (this trial is a 1st line trial)
  • Measurable disease
  • ECOG PS 0-1
  • No uncontrolled BP (SBP>149 or DBP >99) despite optimal antihypertensives
  • No symptomatic CNS involvement
  • No history of Inflammatory Bowel Disease (IBD) requiring treatment in last 12 months
  • No thromboembolic events, cerebrovascular events, acute coronary snydromes, or CHF in the past 6 months
  • No known contraindication to cetuximab administration
  • No uncontrolled glaucoma, hyperviscosity syndrome, or hypercoagulability syndrome
  • No other malignancy within 3 years (if definitively treated and not recurrent) or 5 years (if not definitively treated)
  • No known HIV/HBV/HCV
Objective
  • Primary- Objective Response Rate- (local reads)
  • Secondary- ORR (central read), DoR, TTR, PFS, OS, safety, QoL
Assessment Frequency
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Assessment Frequency 2
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Assessment Frequency Link
Path
BRAF V600E mutant
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X