Ignite Creation Date:
2024-07-17 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469944
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-17
Brief Title:
Substudy 06C A Study of Sacituzumab Tirumotecan MK-2870 With Pembrolizumab MK-3475 and Chemotherapy in Participants With First-Line Locally Advanced UnresectableMetastatic Gastroesophageal Adenocarcinoma MK-3475-06CKEYMAKER-U06
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 12 Open-Label Umbrella Platform Design Study of MK-2870 With Pembrolizumab MK-3475 and Chemotherapy in Participants With 1L Locally Advanced UnresectableMetastatic Gastroesophageal Adenocarcinoma Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma and Esophageal Adenocarcinoma Substudy 06C
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 tolerability of sacituzumab tirumotecan with pembrolizumab and fluoropyrimidine chemotherapy for the first-line 1L treatment of participants with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 HER2-negative gastric gastroesophageal junction or esophageal adenocarcinoma
This substudy will have two phases a safety lead-in phase and an efficacy phase The safety lead-in phase will be used to evaluate the safety and tolerability and to establish a recommended Phase 2 dose RP2D for sacituzumab tirumotecan in combination with chemotherapy and immunotherapy There is no formal hypothesis in this study
This substudy will have two phases a safety lead-in phase and an efficacy phase The safety lead-in phase will be used to evaluate the safety and tolerability and to establish a recommended Phase 2 dose RP2D for sacituzumab tirumotecan in combination with chemotherapy and immunotherapy There is no formal hypothesis in this study
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 |
|---|---|---|---|
| MK-3475-06C | OTHER | None | None |
| KEYMAKER-06C | OTHER | None | None |
| 2023-509307-33 | REGISTRY | None | None |
| U1111-1299-8084 | OTHER | None | None |