Trials / Completed
CompletedNCT01689519
A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 495 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site investigator.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Placebo supplied as tablets |
| DRUG | Vemurafenib | Vemurafenib supplied as tablets |
| DRUG | Cobimetinib | Cobimetinib supplied as tablets |
Timeline
- Start date
- 2013-01-08
- Primary completion
- 2014-05-09
- Completion
- 2019-07-21
- First posted
- 2012-09-21
- Last updated
- 2022-05-02
- Results posted
- 2015-10-30
Locations
156 sites across 19 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Norway, Russia, Spain, Sweden, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01689519. Inclusion in this directory is not an endorsement.