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ACTIVE NOT RECRUITING
NCT06317311
PHASE2

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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

BIOLOGICAL

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)

DRUG

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)

DRUG

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