Ignite Creation Date:
2024-05-06 @ 9:41 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03040999
Status:
COMPLETED
Last Update Posted:
2024-02-26
First Post:
2017-02-01
Brief Title:
Study of Pembrolizumab MK-3475 or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma MK-3475-412KEYNOTE-412
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Randomized Phase III Study of Pembrolizumab Given Concomitantly With Chemoradiation and as Maintenance Therapy Versus Chemoradiation Alone in Subjects With Locally Advanced Head and Neck Squamous Cell Carcinoma KEYNOTE-412
Status:
COMPLETED
Status Verified Date:
2024-08
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:
The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation CRT and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma LA HNSCC The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival EFS
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-003934-25 | EUDRACT_NUMBER | Merck | None |
| MK-3475-412 | OTHER | None | None |
| 173640 | REGISTRY | None | None |
| KEYNOTE-412 | OTHER | None | None |