BRIM 3: A Randomized, Open-label, Controlled, Multicenter, Global Study on Progression-free and Overall Survival in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma With V600E BRAF Mutation Receiving RO5185426 or Dacarbazine
18 Years
N/A
Both
Malignant Melanoma
Trial Information
BRIM 3: A Randomized, Open-label, Controlled, Multicenter, Global Study on Progression-free and Overall Survival in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma With V600E BRAF Mutation Receiving RO5185426 or Dacarbazine
Inclusion Criteria:
- adult patients, >/=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
Exclusion Criteria:
- active CNS 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Description:
An Overall survival event was defined as death due to any cause. The number of participants with overall survival events is reported.
Outcome Time Frame:
From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
NO25026
NCT ID:
NCT01006980
Start Date:
January 2010
Completion Date:
June 2014
Related Keywords:
- Malignant Melanoma
- Melanoma
Name | Location |
|---|---|
| Albany, Georgia 31701 | |
| Birmingham, Alabama 35294 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Columbia, Missouri 65203 | |
| Albany, New York 12208 | |
| Philadelphia, Pennsylvania 19104 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| Flint, Michigan 48532 | |
| Denver, Colorado | |
| Boston, Massachusetts | |
| Charlotte, North Carolina | |
| Eugene, Oregon | |
| Indianapolis, Indiana | |
| Salt Lake City, Utah 84112 |
