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

Official Title

A Phase 3, Randomized, Double-blind, Multicentre Study of Dostarlimab (TSR-042) Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Patients With Recurrent or Primary Advanced Endometrial Cancer (RUBY)

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. Part 1 has completed enrollment, and Part 2 is open for enrollment. Both Parts consist of a Screening Period, Treatment Period, an End of Treatment (EOT) Visit, a Safety Follow-up Visit, and a Survival Assessment Period. In Part 2, participants will be randomized 1:2 to receive either carboplatin/paclitaxel/placebo or Dostarlimab/carboplatin/paclitaxel followed by Dostarlimab/niraparib or placebo iv/oral maintenance.

Trial Description

Primary Outcome:

  • Part 1 and 2: Progression-Free Survival (PFS) - based on blinded independent central review (BICR)
Secondary Outcome:
  • Part 1 and 2: Overall survival (OS)
  • Part 1 and 2: Progression free survival (PFS) - Investigator assessment
  • Part 1 and 2: Objective response rate (ORR) - BICR and Investigator assessment
  • Part 1 and 2: Duration of response (DOR) - BICR and Investigator assessment
  • Part 1 and 2: Disease control rate (DCR) - BICR and Investigator assessment
  • Part 1 and 2: Patient-reported outcomes (PROs) in the European Quality of Life scale, 5-Dimensions, 5-Levels (EQ-5D-5L)
  • Part 1 and 2: PROs in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30 [Core])
  • Part 1 and 2: PROs in the EORTC Quality of Life Questionnaire (QLQ-EN24 [Endometrial Cancer Module])
  • Part 1 and 2: Progression-free survival 2 (PFS2)
  • Part 1 and 2: Number of participants with adverse events (AEs), Serious adverse events (SAEs), adverse event of special interests (AESIs), suspected unexpected serious adverse reaction (SUSAR) and treatment-emergent adverse events (TEAEs)
  • Part 1 and 2: Number of participants with clinically significant changes in clinical laboratory parameters, vital signs, physical examination, electrocardiogram (ECG) and participants reporting the intake of concomitant medication
  • Part 1 and 2: Number of participants with Eastern Cooperative Oncology Group (ECOG) Performance Status Scores
  • Part 1 and 2: Minimum observed concentration (Cmin) and maximum observed concentration (Cmax) of dostarlimab (micrograms per milliliter)
  • Part 1 and 2: Cmin and Cmax at steady state of dostarlimab (micrograms per milliliter)
  • Part 2: Cmin and Cmax of niraparib (micrograms per milliliter)
  • Part 2: Cmin and Cmax at steady state of niraparib (micrograms per milliliter)
  • Part 1 and 2: Number of participants with anti-drug antibodies (ADA) against dostarlimab

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society