A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)
Public ClinicalTrials.gov record NCT01006980. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01006980
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 675 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2010 (Type not available)
- Primary completion
- Dec 2010 (Actual)
- Completion
- Jul 2015 (Actual)
- Last update posted
- Sep 28, 2016
2010 – 2015
United States locations
- U.S. sites
- 24
- U.S. states
- 17
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35243 | — |
| Not listed | Tucson | Arizona | 85724 | — |
| Not listed | Los Angeles | California | 90095-1752 | — |
| Not listed | San Francisco | California | 94117 | — |
| Not listed | Santa Monica | California | 90404 | — |
| Not listed | Aurora | Colorado | 80045 | — |
| Not listed | Atlanta | Georgia | 30322 | — |
| Not listed | Indianapolis | Indiana | 46202 | — |
| Not listed | Boston | Massachusetts | 02114 | — |
| Not listed | Boston | Massachusetts | 02115 | — |
| Not listed | Boston | Massachusetts | 02215 | — |
| Not listed | Detroit | Michigan | 48201 | — |
| Not listed | St Louis | Missouri | 63110 | — |
| Not listed | New York | New York | 10016 | — |
| Not listed | New York | New York | 10065 | — |
| Not listed | Chapel Hill | North Carolina | 27514 | — |
| Not listed | Portland | Oregon | 97213 | — |
| Not listed | Philadelphia | Pennsylvania | 19104 | — |
| Not listed | Pittsburgh | Pennsylvania | 15213-2584 | — |
| Not listed | Nashville | Tennessee | 37203 | — |
| Not listed | Nashville | Tennessee | 37232 | — |
| Not listed | Dallas | Texas | 75246 | — |
| Not listed | Salt Lake City | Utah | 84112 | — |
| Not listed | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 87 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01006980, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 28, 2016 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01006980 live on ClinicalTrials.gov.