Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04924062
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2021-06-08
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-China Extension Study
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:
None
Brief Summary:
In this China Extension study pembrolizumab plus gemcitabinecisplatin will be compared with placebo plus gemcitabinecisplatin as first-line therapy in Chinese adults 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:
The China extension study will include participants previously enrolled in China in the global study for MK-3475-966 NCT04003636 plus those enrolled during the China extension enrollment period A total of approximately 158 Chinese participants will be enrolled
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MK-3475-966 | OTHER | None | None |
| KEYNOTE-966 | OTHER | None | None |
| 195007 | REGISTRY | JAPIC-CTI | None |