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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)

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Trial Profile

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, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Jun 2025

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At a glance

  • Drugs Dostarlimab (Primary) ; Niraparib (Primary) ; Carboplatin; Paclitaxel
  • Indications Carcinoma; Endometrial cancer; Sarcoma
  • Focus Registrational; Therapeutic Use
  • Acronyms RUBY
  • Sponsors TESARO

Most Recent Events

  • 01 Jun 2025 Results assessing Patient-reported outcomes in recurrent endometrial cancer patients treated with dostarlimab ,published in the International Journal of Gynecological Cancer
  • 17 Apr 2025 According to a GSK media release, Health Canada expanded approval to Jemperli (dostarlimab for injection) plus chemotherapy for all adult patients with primary advanced or first recurrent endometrial cancer. Aprroval is based on results of RUBY Part 1.
  • 01 Aug 2024 According to a GSK media release, the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly) in combination with carboplatin and paclitaxel (chemotherapy) followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer.

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