Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia

NCT05405192 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 20210967
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gestational Trophoblastic Neoplasia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Proportion of patients with objective response rate (ORR)

  Up to 25 months

• Number of Participants with treatment related-adverse events

  Up to 25 months

• Progression-free survival (PFS)

  Up to 48 months

• Overall survival (OS)

  Up to 48 months

Study Arms (1)

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.

Drug: Dostarlimab

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.

Dostarlimab Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Gestational Trophoblastic Disease

Interventions

dostarlimab

Condition Hierarchy (Ancestors)

Trophoblastic Neoplasms; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Pregnancy Complications, Neoplastic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Marilyn Huang, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 6, 2022
• Study Start: March 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)