Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459180
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-10
Brief Title:
A Study to Compare Sacituzumab Tirumotecan MK-2870 Monotherapy Versus Treatment of Physicians Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer MK-2870-020TroFuse-020Gog-3101ENGOT-cx20
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 3 Randomized Active-controlled Open-label Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physicians Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer TroFuse-020GOG-3101ENGOT-cx20
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will have two phases a sacituzumab tirumotecan safety run-in and a Phase 3 portion The safety run-in phase will be used to evaluate the efficacy and safety of sacituzumab tirumotecan at the dose for evaluation in the Phase 3 portion The purpose of this study is to compare the efficacy and safety of sacituzumab tirumotecan versus treatment of physicians choice as second-line treatment for participants with recurrent or metastatic cervical cancer in the Phase 3 portion
The primary study hypotheses are that in the Phase 3 portion sacituzumab tirumotecan results in a superior overall survival compared to TPC in participants with high trophoblast cell surface antigen 2 TROP2 expression level and in all participants
The primary study hypotheses are that in the Phase 3 portion sacituzumab tirumotecan results in a superior overall survival compared to TPC in participants with high trophoblast cell surface antigen 2 TROP2 expression level and in all participants
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 |
|---|---|---|---|
| ENGOT-cx20 | OTHER | European Network of Gynaecological Oncological Trial Groups ENGOT | None |
| MK-2870-020 | OTHER | None | None |
| TroFuse-020 | OTHER | None | None |
| 2023-508323-12 | REGISTRY | None | None |
| U1111-1298-0563 | OTHER | None | None |
| GOG-3101 | OTHER | None | None |