Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445972
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-31
Brief Title:
Substudy 06D Combination Therapies in Second Line 2L Gastroesophageal Adenocarcinoma MK-3475-06DKeymaker-U06
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 12 Open-Label Umbrella Platform Design Study to Evaluate the Safety and Efficacy of MK-2870 Plus Paclitaxel as the Second-Line Treatment of Participants With AdvancedMetastatic Gastroesophageal Adenocarcinoma Substudy 06D
Status:
RECRUITING
Status Verified Date:
2024-10
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:
This is a phase 12 multicenter open-label umbrella platform study that will evaluate the safety and efficacy of MK-2870 plus paclitaxel versus Ramucirumab plus paclitaxel for the treatment of participants with advanced or metastatic gastric adenocarcinoma gastroesophageal junction GEJ adenocarcinoma or esophageal adenocarcinoma who have failed 1 prior line of therapy This is an estimation study and no formal hypothesis testing will be performed
Detailed Description:
The master protocol is MK-3475-U06
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 |
|---|---|---|---|
| Keymaker-U06 | OTHER | Merck ID | None |
| 2023-509306-29 | OTHER | None | None |
| U1111-1299-8160 | OTHER | None | None |
| MK-3475-06D | OTHER | None | None |