Ignite Creation Date:
2024-05-06 @ 1:35 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04066491
Status:
TERMINATED
Last Update Posted:
2023-11-14
First Post:
2019-08-22
Brief Title:
Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa M7824 in Participants With 1L BTC
Sponsor:
EMD Serono Research Development Institute Inc
Organization:
EMD Serono
Study Overview
Official Title:
A Phase IIIII Multicenter Randomized Placebo-controlled Study of Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa M7824 as First-line Treatment of Biliary Tract Cancer
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Based on a review of data conducted by the Independent Data Monitoring Committee IDMC Sponsor decided to discontinue this study as the study was unlikely to achieve the primary objective of overall survival
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study consisted of an open-label safety run-in part and a randomized double-blind placebo-controlled Phase 23 part In the Phase 23 part the study was evaluated whether bintrafusp alfa in combination with the current standard of care SoC gemcitabine plus cisplatin improves overall survival OS in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic Biliary Tract Cancer BTC compared to placebo gemcitabine and cisplatin
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 |
|---|---|---|---|
| 2019-001992-35 | EUDRACT_NUMBER | None | None |