A Phase 3 Research Study for Women with Recurrent or Primary Advanced Endometrial Cancer

IRB/UVA Tracking #
21790
Principal Investigator
Kari E Ring
Contact
Sheena Clift
Contact Phone
434.924.2745
Official Trial Title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY OF DOSTARLIMAB (TSR-042) PLUS CARBOPLATIN-PACLITAXEL VERSUS PLACEBO PLUS CARBOPLATIN-PACLITAXEL IN PATIENTS WITH RECURRENT OR PRIMARY ADVANCED ENDOMETRIAL CANCER (RUBY)
Study Description

The UVA Cancer Center has a clinical trial for women ages 18 and over who have recurrent or primary advanced endometrial cancer.

The purpose of this trial is to find out if an investigational drug called dostarlimab (also known as TSR-042) in combination with chemotherapy (carboplatin and paclitaxel), can help delay the worsening of your cancer. If you agree to be in this study, you will be randomly assigned to receive the dostarlimab infusion or a placebo infusion. A placebo contains no active study drug and is like a sugar pill or water.

The overall trial does not have a set duration. Study treatment may continue for as long as your study doctor thinks the medicine is helping you or another reason for discontinuation has been presented. After you have stopped taking the study drug, you will be asked to stay in the study for follow-up, at which point you will be contacted via phone every 3 months to give your study team updates on your health and how you are feeling. You may also be required to visit your study doctor for additional assessments, such as regular CT/MRI scans, until the study is completed.

If eligible and you choose to participate, the costs of standard tests, procedures, and treatment of complications will be paid by your insurer in the same way as if you were not part of this study. You may be responsible for any extra costs your insurance company does not pay.

Additional information can be found here: NCT03981796

Compensation

You will be paid $40 for each completed cycle for up to 15 cycles. You will be paid following each completed visit.