Ignite Creation Date:
2024-05-06 @ 1:35 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04068753
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2019-08-22
Brief Title:
Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
Phase II Trial of Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer OU-SCC-STAR
Status:
RECRUITING
Status Verified Date:
2024-05
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:
STAR
Brief Summary:
The purpose of this research study is to test the safety of Niraparib and dostarlimab as a combination treatment and see what effects good and bad this combination treatment has on patients with recurrent or progressive cervix cancer
Detailed Description:
Patients will have tests and exams to see if they are eligible for the clinical trial If found eligible the patient will receive treatment with Niraparib daily and dostarlimab by vein every three weeks for 4 cycles then every six weeks
Patients will receive the study treatment as long as there is evidence that the tumor is not growing or spreading and they are not having any unacceptable bad side effects
Patients will be monitored during treatment with tests and exams and after treatment completion for up to 5 years
Patients will receive the study treatment as long as there is evidence that the tumor is not growing or spreading and they are not having any unacceptable bad side effects
Patients will be monitored during treatment with tests and exams and after treatment completion for up to 5 years
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 |
|---|---|---|---|
| OU-SCC-TESARO-002 | OTHER_GRANT | Tesaro Inc | None |