NCT06317311

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

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)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Carcinoma

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-05-07
• Primary completion: 2026-07-15
• Completion: 2027-08-31
• First posted: 2024-03-19
• Last updated: 2025-07-25

Locations

20 sites across 1 country: Japan