Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia

Gestational Trophoblastic Neoplasia Clinical Trial

Official title:

Phase 2 Single Agent Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia (GTN)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05405192
• Other study ID #: 20210967
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 1, 2023
• Est. completion date: December 1, 2028

Study information

• Verified date: February 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2028
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with persistent unresectable Gestational Trophoblastic Neoplasia (GTN) disease

2. Female patients >18 years old.

3. Pretreatment archival tissue (if available) must be submitted for correlative studies. If pre-treatment tissue is not available, this does not exclude the patient.

4. 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 Criteria:

1. Prior therapy with anti-Programed Death (PD)1/Programed Death Ligand-1 (PD-L1) or anti-CTLA4 antibody

2. Participant must not be simultaneously enrolled in any interventional clinical trial.

3. Participant must not have had major surgery =3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.

4. 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.

Related Conditions & MeSH terms

• Gestational Trophoblastic Disease
• Gestational Trophoblastic Neoplasia
• Neoplasms

Intervention

Drug:
• Dostarlimab
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.

Locations

Country	Name	City	State
United States	University of Miami Sylvester Comprehensive Cancer Center	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of Participants with treatment related-adverse events	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
Secondary	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
Secondary	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