CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 785 enrolled
Drug / intervention
Dostarlimab +5 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03981796
NCT03981796Phase 3Active
CompareCT.gov

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)

Tesaro, Inc.·interventional·Posted Jun 11, 2019·Updated Sep 3, 2025

In Brief

A Phase 3 clinical trial evaluating Dostarlimab, Placebo matching dostarlimab, and 4 other interventions for Neoplasms. Active but no longer recruiting, targeting 785 participants across 169 sites in 20 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesBelarus, Belgium, Canada, Czechia, Denmark, Finland, Germany, Greece, Hungary, Israel, Italy, Netherlands, Norway, Poland, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsEuropean Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation

Timeline

Phase 3Active
20202021202220232024202520262027
First PostedJun 11, 2019
Enrollment StartJul 18, 2019
Primary CompletionNov 26, 2026
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 7.1 years agoPrimary completion in 5 months

Interventions

Dostarlimabbiological

Participants will be administered dostarlimab

Placebo matching dostarlimabdrug

Participants will be administered placebo matching dostarlimab

Carboplatindrug

Participants will be administered carboplatin

Paclitaxeldrug

Participants will be administered paclitaxel

Niraparibdrug

Participants will be administered niraparib

Placebo matching Niraparibdrug

Participants will be administered placebo matching Niraparib