West Cancer Center

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

NCT03693170

Malignancy

Colorectal cancer, colon cancer, rectum cancer

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st Line

Investigational Agent

Encorafenib, Binimetinib, Cetuximab

Drug Class

BRAF inhibitor, MEK inhibitor, EGFR antibody

Axel Grothey, MD

Sponsor

Pierre Fabre Medicament

Phase

Phase 2

Status

Closed to Accrual

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

Assessment Frequency 2

Assessment Frequency Link

Path

BRAF V600E mutant

Dosing Frequency

Control Agents

Study Protocol

Randomized