Ignite Creation Date:
2024-05-06 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03358472
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2017-11-27
Brief Title:
Pembrolizumab Plus Epacadostat Pembrolizumab Monotherapy and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma KEYNOTE-669ECHO-304
Sponsor:
Incyte Corporation
Organization:
Incyte Corporation
Study Overview
Official Title:
A Phase 3 Randomized Open-Label Clinical Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Epacadostat Pembrolizumab Monotherapy and the EXTREME Regimen as First Line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma KEYNOTE-669ECHO-304
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat pembrolizumab monotherapy and the EXTREME regimen cetuximab cisplatin or carboplatin 5-fluorouracil as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma HNSCC
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None