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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

October 15, 2019

Primary Completion Date

March 22, 2024

Study Completion Date

December 18, 2025

Conditions
Endometrial CancerCancer of the Endometrium
Interventions
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

Trial Locations (1)

63110

Washington University School of Medicine, St Louis

All Listed Sponsors
collaborator

Tesaro, Inc.

INDUSTRY

lead

Washington University School of Medicine

OTHER

NCT03955978 - TSR-042 in Addition to Standard of Care Definitive Radiation for Inoperable Endometrial Cancer | Biotech Hunter | Biotech Hunter