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Active, not recruiting Phase 2

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

NCT06317311 · tracked via the Priya Life Science Japan tracker
Phase
Phase 2
Started
2024-05-07
Last updated
2025-07-25

Condition(s) studied

Carcinoma

Investigational drug(s) / intervention(s)

Dostarlimab →Carboplatin →Paclitaxel →

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)

Study 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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Participant has histologically or cytologically proven endometrial cancer with recurrent or advanced disease. 2. Participant has molecular subtype of defective mismatch repair/microsatellite instability high (dMMR/MSI-H) or mismatch repair proficient/microsatellite stable (MMRp/MSS) determined. 3. Participant must have primary Stage III or Stage IV disease or first recurrent endometrial cancer with a low potential for cure by radiation therapy or surgery alone or in combination, and presence of at least one measurable lesion per RECIST 1.1 based on Investigator's assessment. 4. Participant is not pregnant or breastfeeding and agrees to use a highly effective contraceptive method during the study period if a woman of childbearing potential (WOCBP). 5. Participant has an Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0 or 1. 6. Participant has adequate organ function, as assessed by hematologic, renal, hepatic and coagulation parameters. Exclusion Criteria: 1. Participant has a concomitant malignancy, or participant has a prior non-endometrial invasive malignancy who has been disease-free for \<3 years or who received any active treatment in the last 3 years for that malignancy. Non-melanoma skin cancer is allowed. 2. Participant has any medical history of interstitial lung disease or pneumonitis. 3. Participant has cirrhosis or current unstable liver or biliary disease. 4. Participant has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both. 5. Participant has a diagnosis of immunodeficiency. 6. Participant has received prior therapy with an anti- Programmed death protein 1 (PD-1), anti- Programmed death ligand 1 (PD-L1), anti- Programmed death ligand 2 (PD-L2), or anti- Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) agent. 7. Participant has not recovered adequately from AEs. 8. Participant has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy, or immunotherapy) within 21 days or \<5 times the half-life of the most recent therapy prior to the first dose of study intervention, whichever is shorter. 9. Participant has received any live vaccine within 30 days of the first dose of study intervention. Vaccination against coronavirus disease 2019 (COVID-19) using vaccines that are authorized via the appropriate regulatory mechanisms are not exclusionary. 10. Participant has HBsAg positive, or HCV RNA positive. 11. Participant is known HIV infection. 12. Participant is currently participating and receiving study intervention or has participated in a study of an investigational agent and received study intervention or used an investigational device within 4 weeks of the first dose of treatment. 13. Participant with contraindication to carboplatin and paclitaxel.

Primary outcome measure(s)

  • Durable response rate for 12 months (DRR12) assessed by Blinded independent central review (BICR) — Approximately 18 months
    DRR12 is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR) lasting greater than or equal to (≥) 12 months, per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

Trial sites (20)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06317311 on ClinicalTrials.gov ↗ ← All trials in Japan