GOG-3031 Tesaro Ruby Endometrial - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about how the study drugs (Dostarlimab and niraparib) can help slow endometrial cancer when used in combination with chemotherapy.

What is the Condition Being Studied?

Endometrial Cancer

Who Can Participate in the Study?

Adult women diagnosed with endometrial cancer

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Be randomized (like the flip of a coin) to Group 1 or Group 2
-- Group 1 will get the study drug (Dostarlimab) with chemotherapy then get dostarlimab and niraparib (a second study drug) tablets for maintenance
-- Group 2 will get a placebo (harmless solution, like saltwater) infusion with chemotherapy and placebo infusion with placebo tablets for maintenance

Both groups will:
- Get their infusions of chemotherapy with dostarlimab/placebo every 3 weeks for 18 weeks
- Get their infusions of dostarlimab or placebo every 6 weeks for up to 3 years
- Get niraparib/placebo tablets to take daily for up to 3 years
- Complete a follow-up visit 3 months after completing the study drug regimen
- Complete follow-up visits every 3 months after that

Study Details

Full Title
A Phase 3, Randomized, Double-Blind, Multicenter Study of Dostarlimab (TSR-042) Plus Carboplatin-Paclitaxel Versus Placebo Versus Placebo Plus Carboplatin-Paclitaxel in Patients with Recurrent or Primary Advanced Endometrial Cancer (RUBY)
Principal Investigator
Gynecologic Oncologist
Protocol Number
IRB: PRO00104077
NCT: NCT03981796
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698