Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04697628
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2021-01-04
Brief Title:
Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer
Sponsor:
Seagen Inc
Organization:
Seagen Inc
Study Overview
Official Title:
A Randomized Open-Label Phase 3 Trial of Tisotumab Vedotin vs Investigators Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
innovaTV 301
Brief Summary:
This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer People in this study have cervical cancer that has spread to other parts of the body metastatic or has come back after being treated recurrent
Participants in this trial will be randomly assigned to one of two groups One group will be treated with tisotumab vedotin Participants in the other group will get one of five different chemotherapy drugs topotecan vinorelbine gemcitabine pemetrexed or irinotecan Participants and their doctors will know which group they are in Participants in the chemotherapy group will decide with their study doctor which drug they will take
Participants in this trial will be randomly assigned to one of two groups One group will be treated with tisotumab vedotin Participants in the other group will get one of five different chemotherapy drugs topotecan vinorelbine gemcitabine pemetrexed or irinotecan Participants and their doctors will know which group they are in Participants in the chemotherapy group will decide with their study doctor which drug they will take
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 cx-12 | OTHER | None | None |
| GOG-3057 | OTHER | GOG Foundation | None |