A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer
NCT06317311 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41
Last updated 2025-07-25
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
- 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 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 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)
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-07
- Primary Completion
- 2026-07-15
- Completion
- 2027-08-31
Countries
- Japan
Study Locations
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