10
Participants
Start Date
October 15, 2019
Primary Completion Date
March 22, 2024
Study Completion Date
December 18, 2025
TSR-042
-TSR-042 is administered intravenously via a 30-minute (-5-minute/+15-minute infusion window allowed) infusion
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.
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
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
Washington University School of Medicine, St Louis
Tesaro, Inc.
INDUSTRY
Washington University School of Medicine
OTHER