Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • 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)

    Cancer Categories
    • Gynecologic
    Karmanos Trial ID
    • GOG-3031
    NCT ID
    • NCT03981796
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase III
    Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug
    • Phase III
    Principal Investigator
    • Radhika
      Gogoi, M.D., Ph.D.

      Oncology - Gynecologic, Oncology - Surgical View Profile

    Objective:

    Primary Objective(s):
    1. To compare the PFS of treatment with dostarlimab plus carboplatin-paclitaxel to treatment with placebo plus carboplatin-paclitaxel, as assessed by the RECIST v.1.1, in the following:
      • All subjects with recurrent or primary advanced endometrial cancer
      • Subjects with MSI-H recurrent or primary advanced endometrial cancer
    Secondary Objective(s):
    1. To evaluate the following measures of clinical benefit of treatment with dostarlimab plus carboplatin-paclitaxel compared to treatment with placebo plus carboplatin-paclitaxel in subjects with recurrent or primary advanced endometrial cancer:
      • PFS based on blinded independent central review (BICR)
      • OS
      • ORR
      • DOR
      • Disease control rate (DCR)
      • Patient-reported outcomes (PROs): European Quality of Life scale, 5-Dimensions, 5-Levels (EQ-5D-5L) and European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ-C30 [Core] and QLQ-EN24 [Endometrial Cancer Module])
    2. To evaluate the safety and tolerability of dostarlimab plus carboplatin-paclitaxel compared to placebo plus carboplatin-paclitaxel
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266

    Karmanos Cancer Institute at Lawrence and Idell Weisberg Cancer Treatment Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266