Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia

Conditions

• Gestational Trophoblastic Neoplasia

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

The purpose of this study is to see if Dostarlimab is an effective treatment for Gestational Trophoblastic Neoplasia (GTN).

Key Dates

Start date

Mar 1, 2023

Status verified

Feb 2023

Primary completion

Dec 1, 2026

Completion

Dec 1, 2028

Study Design

Enrollment

0 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Dostarlimab Group
  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.

Primary Outcome Measure

Proportion of patients with successful normalization of beta hCG [ Time Frame: Up to 24 months ]

Locations (1)

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