A Phase III Study Comparing Vemurafenib vs Vemurafenib Plus Cobimetinib (GDC-0973) in Patients With Metastatic Melanoma (coBRIM)

This multicenter, randomized, double-blind, placebo-controlled phase III study will evaluate the safety and efficacy of vemurafenib alone and vemurafenib in combination with cobimetinib (GDC-0973), a mitogen-activated protein kinase (MEK) inhibitor, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma. Patients will be randomized to one of two treatment arms, Arm A: vemurafenib 960 mg twice a day (days 1-28 of each cycle) and placebo (days 1-21 of each cycle); Arm B: vemurafenib 960 mg twice a day (days 1-28 of each cycle) and cobimetinib (GDC-0973) 60 mg once daily (days 1-21 of each cycle). Patients will receive treatment until disease progression, unacceptable toxicity, or withdrawal of consent.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Double-blind, Placebo-controlled Study of Vemurafenib Versus Vemurafenib Plus GDC-0973 in Previously Untreated BRAF^600-mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma
Enrollment: 495
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Arms:
- Active Comparator: Placebo + vemurafenib
- Experimental: Cobimetinib + vemurafenib