West Cancer Center

MELANOMA: Adjuvant: BRAF mutant: "BRIM-8"

A phase III, randomized, double-blind, placebo-controlled study of vemurafenib (RO5185426) adjuvant therapy in patients with surgically resected, cutaneous BRAF mutant melanoma at high risk for recurrence

Title

Hoffman-La Roche GO27826

Study Title

Site Link

NCT01667419

Malignancy

Melanoma, Skin Cancer

Stage

Stage 2

Disease Setting

Adjuvant

Line Of Therapy

N/A

Investigational Agent

Vemurafenib

Drug Class

BRAF inhibitor

Brad Somer, MD

Sponsor

Hoffman-La Roche

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT01667419?term=GO27826&rank=1

Key Eligibility Criteria Details

BRAF mutation (may be enrolled with unknown status as central testing required)
Stage IIC-III

Complete surgical excision within 90 days of start
ECOG PS 0-1
Life expectancy of at least 5 years
No history of limb-perfusion therapy
No history of XRT for melanoma
No prior melanoma systemic therapy

Objective

Primary- DFS: Secondary- OS, Distant Mets Free Survival, Safety, QOL, PK

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

BRAF mutation

Dosing Frequency

Vemurafenib 960mg bid x 1yr

Control Agents

Placebo

Study Protocol

Randomized

Yes