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PI is leaving the University.
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to see if Dostarlimab is an effective treatment for Gestational Trophoblastic Neoplasia (GTN).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dostarlimab Group | Experimental | Participants will receive a total of up to 20 cycles of Dostarlimab: 4 cycles of Dostarlimab at a dose of 500 mg on day 1 of each of the 21-day cycle and 16 cycles of Dostarlimab at a dose of 1000 mg on day 1 of each of the 42-day cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dostarlimab | Drug | First four cycles of Dostarlimab will be given intravenously (IV) on day 1 of each of the 21-day cycle at a dose of 500 milligrams (mg). The next 16 cycles of Dostarlimab will be given on day 1 of each of the 42-day cycles at a dose of 1,000 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with successful normalization of beta hCG | Proportion of patients with a successful normalized serum human chorionic gonadotropin (hCG) level (complete response) as measured by serum samples. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with objective response rate (ORR) | ORR is defined as achieving best response of complete or partial responses (CR or PR) as assessed via Response Evaluated Criteria in Solid Tumors (RECIST) | Up to 25 months |
| Number of Participants with treatment related-adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marilyn Huang, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D031901 | Gestational Trophoblastic Disease |
| ID | Term |
|---|---|
| D014328 | Trophoblastic Neoplasms |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000719628 | dostarlimab |
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Non-hematological Grade 3 and higher treatment-related adverse events as evaluated by treating physician using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5. |
| Up to 25 months |
| Progression-free survival (PFS) | PFS is the elapsed time from the date of treatment initiation to date of first documentation of progression (or recurrence) or death due to any cause. Patients last known to be alive and free of disease will be censored at date of last documented progression-free status. | Up to 48 months |
| Overall survival (OS) | OS is the elapsed time from treatment initiation to death. For alive patients, OS will be censored at the date last known to be alive. | Up to 48 months |
| D011252 | Pregnancy Complications, Neoplastic |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |