NCT03981796

A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 785 (actual)
• Sponsor: Tesaro, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 2 part study. Part 1 is to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel followed by dostarlimab versus placebo plus carboplatin-paclitaxel followed by placebo; and Part 2 is to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel followed by dostarlimab plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo in participants with recurrent or primary advanced (Stage III or IV) endometrial cancer.

Conditions

• Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	Dostarlimab	Participants will be administered dostarlimab
DRUG	Placebo matching dostarlimab	Participants will be administered placebo matching dostarlimab
DRUG	Carboplatin	Participants will be administered carboplatin
DRUG	Paclitaxel	Participants will be administered paclitaxel
DRUG	Niraparib	Participants will be administered niraparib
DRUG	Placebo matching Niraparib	Participants will be administered placebo matching Niraparib

Timeline

• Start date: 2019-07-18
• Primary completion: 2026-11-26
• Completion: 2026-11-26
• First posted: 2019-06-11
• Last updated: 2025-09-03

Locations

169 sites across 20 countries: United States, Belarus, Belgium, Canada, Czechia, Denmark, Finland, Germany, Greece, Hungary, Israel, Italy, Netherlands, Norway, Poland, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study