Ignite Creation Date:
2024-05-06 @ 1:23 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04003636
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2019-06-28
Brief Title:
Pembrolizumab MK-3475 Plus GemcitabineCisplatin Versus Placebo Plus GemcitabineCisplatin for First-Line Advanced andor Unresectable Biliary Tract Carcinoma BTC MK-3475-966KEYNOTE-966
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 3 Randomized Double Blind Study of Pembrolizumab Plus GemcitabineCisplatin Versus Placebo Plus GemcitabineCisplatin as First-Line Therapy in Participants With Advanced andor Unresectable Biliary Tract Carcinoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
KEYNOTE-966
Brief Summary:
This is a study of pembrolizumab plus gemcitabinecisplatin versus placebo plus gemcitabinecisplatin as first-line therapy in participants with advanced andor unresectable biliary tract carcinoma The primary hypothesis is pembrolizumab plus gemcitabinecisplatin is superior to placebo plus gemcitabinecisplatin with respect to overall survival OS
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 |
|---|---|---|---|
| 2019-000944-82 | EUDRACT_NUMBER | JAPIC-CTI | None |
| MK-3475-966 | OTHER | None | None |
| KEYNOTE-966 | OTHER | None | None |
| 195007 | REGISTRY | None | None |