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

Completed · Phase 3

Conditions studied: Malignant Melanoma

In brief

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.

Key facts

Study ID

NCT01006980

Run by

Hoffmann-La Roche

People needed

675

Starts

2010-01-01

Expected to finish

2015-07-01

Last updated by the study team

2016-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adults, >/=18 years of age
• metastatic melanoma, stage IIIC or IV (AJCC)
• treatment-naïve (no prior systemic anticancer therapy)
• positive for BRAF V600E mutation
• measurable disease by RECIST criteria
• negative pregnancy test and, for fertile men and women, effective contraception during treatment and for 6 months after completion

You may not qualify if…

• active central nervous system metastases
• history of carcinomatous meningitis
• severe cardiovascular disease within 6 months prior to study drug administration
• previous malignancy within 5 years prior to study, except for basal or squamous cell carcinoma of the skin, melanoma in-situ, or carcinoma in-situ of the cervix

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — Santa Monica, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Atlanta, Georgia, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Nashville, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Seattle, Washington, United States
• Study site — Brisbane, Australia
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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