NCT01006980

A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)

BRIM 3: A Randomized, Open-Label, Controlled, Multicenter, Phase III Study in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma With V600E BRAF Mutation Receiving Vemurafenib (RO5185426) or Dacarbazine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 675 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized, open-label study evaluated the efficacy, safety and tolerability of vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Study treatment was continued until disease progression or unacceptable toxicity occurred. The data and safety monitoring board recommended that patients in the dacarbazine group be allowed to cross over to receive vemurafenib, and the protocol was amended accordingly on January 14, 2011, as both overall survival and progression-free survival endpoints had met the prespecified criteria for statistical significance in favor of vemurafenib.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Vemurafenib	960 mg (as 240 mg tables) orally twice daily
DRUG	Dacarbazine	1000 mg/m2 intravenously every 3 weeks

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-12-01
• Completion: 2015-07-01
• First posted: 2009-11-03
• Last updated: 2016-09-28
• Results posted: 2011-11-16

Locations

111 sites across 12 countries: United States, Australia, Canada, France, Germany, Israel, Italy, Netherlands, New Zealand, Sweden, Switzerland, United Kingdom