NCT03955978

TSR-042 in Addition to Standard of Care Definitive Radiation for Inoperable Endometrial Cancer

A Phase I Study of PD-1 Inhibition With TSR-042 in Addition to Standard of Care Definitive Radiation for Inoperable Endometrial Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with inoperable endometrial cancer have limited treatment options. PD-L1 expression is common in endometrial cancers and RT induces tumor and systemic changes that induce the immune system. The purpose of this trial is to evaluate anti-PD-1/PD-L1 axis therapy in conjunction of standard of care RT for patients with inoperable endometrial cancer in order to establish the safety and efficacy of inducing an anti-tumor immune response.

Conditions

• Endometrial Cancer
• Cancer of the Endometrium

Interventions

Type	Name	Description
DRUG	TSR-042	-TSR-042 is administered intravenously via a 30-minute (-5-minute/+15-minute infusion window allowed) infusion
RADIATION	Brachytherapy	-This trial will include image-guided brachytherapy with three-dimensional (3-D) treatment planning and in cases where pelvic radiation is deemed appropriate by the treating radiation oncologist, external beam radiation therapy (EBRT) using intensity modulated radiation therapy (IMRT) technique.
PROCEDURE	Endometrial biopsy	-Prior to the start of treatment with TSR-042. If this biopsy yields insufficient tumor tissue, an archival sample may be requested, with Fraction 1 of brachytherapy, with Fraction 4 of brachytherapy
PROCEDURE	Blood draw for immune response	-Prior to the start of any treatment, at the time of brachytherapy fractions 1 and 4 (corresponding to endometrial biopsy), prior to fourth dose of TSR-042, 6 weeks after the completion of all protocol related therapy

Timeline

• Start date: 2019-10-15
• Primary completion: 2024-03-22
• Completion: 2029-02-01
• First posted: 2019-05-20
• Last updated: 2026-01-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study