Ignite Creation Date:
2024-05-06 @ 8:32 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02768207
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2016-05-09
Brief Title:
A Study to Detect V-Raf Murine Sarcoma Viral Oncogene Homolog B1 BRAF V600 Mutation on Cell-Free Deoxyribonucleic Acid cfDNA From Plasma in Participants With Advanced Melanoma
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Single Arm Open Label Phase II Multicenter Study to Assess The Detection of The BRAF V600 Mutation on cfDNA From Plasma in Patients With Advanced Melanoma
Status:
COMPLETED
Status Verified Date:
2019-08
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:
None
Brief Summary:
This is a single arm multicenter open label and non-randomized clinical study on adult participants with unresectable or metastatic melanoma The study will be conducted in two phases Pre-screening phase will assess the BRAF V600 mutation in a new mutation analysis triggered by a mutant plasma cfDNA test result Treatment phase will assess the clinical outcome for the participants treated with vemurafenib plus cobimetinib The length of the study will be approximately 38 months
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 |
|---|---|---|---|
| 2015-001731-20 | EUDRACT_NUMBER | None | None |