WithdrawnPhase 2

Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia

Stopped: PI is leaving the University.

United States0Started 2023-03-01

Plain-language summary

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

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. 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.

Proportion of patients with successful normalization of beta hCG

Timeframe: Up to 24 months

NCT IDNCT05405192

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01