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RUBY-JNCT06317311

A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer

StatusActive, Not Recruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary completion moved at least 4 months later.

See at-risk trials from GlaxoSmithKline

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Record History

All 6 versions: 6 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jul 15, 2026 to Dec 14, 2026 Show 4 more changesShow less
    • Trial sites reduced: 20 → 15 locations
    • Study completion pushed from Aug 31, 2027 to Sep 30, 2028
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 2 of 14 entries
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 20 of 20 sites
    v5
  3. Enrollment target: 36 to 41v4
  4. Site details revised at 13 of 20 sitesv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 16, 2024 to May 7, 2024
    • Site details revised at 20 of 20 sites
    v2
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Durable response rate for 12 months (DRR12) assessed by Blinded independent central review (BICR)
Timeframe: Approximately 18 months

Secondary (14)

DRR12 per RECIST 1.1, assessed by investigator
Progression-free survival (PFS) per RECIST 1.1, assessed by BICR and investigator
Overall survival (OS)
Overall response rate (ORR) per RECIST 1.1 assessed by BICR
ORR per RECIST 1.1 assessed by investigator
Show 9 moreShow less
Disease control rate (DCR) per RECIST 1.1 assessed by BICR
DCR per RECIST 1.1 assessed by investigator
Duration of response (DOR) per RECIST 1.1 assessed by BICR
DOR per RECIST 1.1 assessed by investigator
Maximum concentration (Cmax) for dostarlimab
Minimum concentration (Cmin) for dostarlimab
Number of participants with adverse events (AEs), Immune-related adverse events (irAEs), and serious adverse events (SAEs) by severity
Number of participants AEs, irAEs, and SAEs leading to dose modifications such as dose delay or study intervention discontinuation
Number of participants with AEs leading to death

Arms and interventions

Dostarlimab- Carboplatin-Paclitaxel followed by Dostarlimab MonotherapyExperimental

Biologicals: Dostarlimab

Drugs: Carboplatin, Paclitaxel

Sites

15 sites in 1 country