Ignite Creation Date:
2024-05-06 @ 12:53 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01689519
Status:
COMPLETED
Last Update Posted:
2022-05-02
First Post:
2012-09-18
Brief Title:
A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Phase III Double-Blind Placebo-Controlled Study of Vemurafenib Versus Vemurafenib Plus GDC-0973 in Previously Untreated BRAF600-Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
coBRIM
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-003008-11 | EUDRACT_NUMBER | None | None |