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| ID | Type | Description | Link |
|---|---|---|---|
| OU-SCC-TESARO-002 | Other Grant/Funding Number | Tesaro, Inc. |
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| Name | Class |
|---|---|
| Tesaro, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niraparib + dostarlimab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niraparib | Drug | Niraparib: 200 mg, oral, once daily, days 1-21 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with response to treatment | The proportion of patients treated with Niraparib and dostarlimab who achieve CR or PR, evaluated using RECIST v1.1 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who experience toxicity | To determine the nature and degree of toxicity in combination of Niraparib and dostarlimab | 2 years |
| Duration of patients with response | To estimate the duration of response of patients treated with combination of Niraparib and dostarlimab |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debra Richardson, MD | Stephenson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Melvin and Bren Simon Comprehensive Cancer Center | Indianapolis | Indiana | 46202 | United States | ||
| Louisiana State University Health Science Center |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C545685 | niraparib |
| C000719628 | dostarlimab |
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| dostarlimab |
| Drug |
dostarlimab: 500 mg IV, every three weeks for 4 cycles followed by 1000 mg every six weeks for up to two years |
|
| up to 5 years |
| Progression free survival | To estimate the progression free survival of patients treated with combination of Niraparib and dostarlimab | up to 5 years |
| Overall survival | To estimate the overall survival of patients treated with combination of Niraparib and dostarlimab | up to 5 years |
| New Orleans |
| Louisiana |
| 70112 |
| United States |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22903 | United States |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |