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A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer
Sponsor: GlaxoSmithKline
Summary
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
Official title: A Phase 2, Multicenter, Open-label, Single Arm Study of Dostarlimab Plus Carboplatin-paclitaxel Followed by Dostarlimab Monotherapy in Japanese Patients With Primary Advanced or Recurrent Endometrial Cancer (RUBY-J)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
41
Start Date
2024-05-07
Completion Date
2027-08-31
Last Updated
2025-07-25
Healthy Volunteers
No
Conditions
Interventions
Dostarlimab
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
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
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)
Locations (20)
GSK Investigational Site
Aichi, Japan
GSK Investigational Site
Chiba, Japan
GSK Investigational Site
Ehime, Japan
GSK Investigational Site
Fukuoka, Japan
GSK Investigational Site
Fukuoka, Japan
GSK Investigational Site
Gunma, Japan
GSK Investigational Site
Hokkaido, Japan
GSK Investigational Site
Hyōgo, Japan
GSK Investigational Site
Ibaraki, Japan
GSK Investigational Site
Kanagawa, Japan
GSK Investigational Site
Numakunai, Japan
GSK Investigational Site
Okayama, Japan
GSK Investigational Site
Osaka, Japan
GSK Investigational Site
Osaka, Japan
GSK Investigational Site
Saitama, Japan
GSK Investigational Site
Shizuoka, Japan
GSK Investigational Site
Tochigi, Japan
GSK Investigational Site
Tokyo, Japan
GSK Investigational Site
Tokyo, Japan
GSK Investigational Site
Tokyo, Japan