Status:
WITHDRAWN
Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia
Lead Sponsor:
University of Miami
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Gestational Trophoblastic Neoplasia
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see if Dostarlimab is an effective treatment for Gestational Trophoblastic Neoplasia (GTN).
Eligibility Criteria
Inclusion
- Patients with persistent unresectable Gestational Trophoblastic Neoplasia (GTN) disease
- Female patients \>18 years old.
- Pretreatment archival tissue (if available) must be submitted for correlative studies. If pre-treatment tissue is not available, this does not exclude the patient.
- Patients must have recovered from the effects of recent surgery or radiotherapy (persistent toxicity, CTCAE grade ≤1 except for alopecia, sensory neuropathy, or fatigue).
Exclusion
- Prior therapy with anti-Programed Death (PD)1/Programed Death Ligand-1 (PD-L1) or anti-CTLA4 antibody
- Participant must not be simultaneously enrolled in any interventional clinical trial.
- Participant must not have had major surgery ≤3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
- Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05405192
Start Date
March 1 2023
End Date
December 1 2028
Last Update
February 28 2023
Active Locations (1)
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1
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136