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

Sponsor
GlaxoSmithKline
Study ID
NCT06317311
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dostarlimab — BIOLOGICAL
    Dostarlimab is administered via intravenous (IV) infusion at a dose of 500 milligram (mg) for first 6 cycles (each cycle is of 21 days) followed by 1,000 mg from cycle 7 (each cycle is of 42 days)
  • Carboplatin — DRUG
    Carboplatin is administered IV at a dose of Area under the concentration time curve (AUC) 5 milligram\*millilitre/ minute (mg•mL/min) for cycles 1 to 6 (each cycle is of 21 days)
  • Paclitaxel — DRUG
    Paclitaxel is administered IV at a dose of 175 milligram per meter square (mg/m2) for cycles 1 to 6 (each cycle is of 21 days)

Study Details

The goal of this clinical trial is to understand the effectiveness of dostarlimab and carboplatin-paclitaxel followed by dostarlimab monotherapy in participants with endometrial cancer

Key Dates

Start date
May 7, 2024
Status verified
Jul 2025
Primary completion
Jul 15, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
41 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dostarlimab- Carboplatin-Paclitaxel followed by Dostarlimab Monotherapy

Primary Outcome Measure

Durable response rate for 12 months (DRR12) assessed by Blinded independent central review (BICR) [ Time Frame: Approximately 18 months ]

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