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

NCT06317311 | Active Not Recruiting Phase 2

• 1 other identifier: 221968
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 20

Brief 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

Keywords

Endometrial cancer; Dostarlimab; Carboplatin; Paclitaxel

Outcome Measures

Primary Outcomes (1)

• Durable response rate for 12 months (DRR12) assessed by Blinded independent central review (BICR)

  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)

  Approximately 18 months

Secondary Outcomes (14)

• DRR12 per RECIST 1.1, assessed by investigator

  Approximately 18 months

• Progression-free survival (PFS) per RECIST 1.1, assessed by BICR and investigator

  Up to approximately 3 years

• Overall survival (OS)

  Up to approximately 3 years

• Overall response rate (ORR) per RECIST 1.1 assessed by BICR

  Up to approximately 3 years

• ORR per RECIST 1.1 assessed by investigator

  Up to approximately 3 years

Study Arms (1)

Dostarlimab- Carboplatin-Paclitaxel followed by Dostarlimab Monotherapy

EXPERIMENTAL

Biological: Dostarlimab; Drug: Carboplatin; Drug: Paclitaxel

Interventions

Dostarlimab BIOLOGICAL

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)

Dostarlimab- Carboplatin-Paclitaxel followed by Dostarlimab Monotherapy

Carboplatin 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)

Dostarlimab- Carboplatin-Paclitaxel followed by Dostarlimab Monotherapy

Paclitaxel 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)

Dostarlimab- Carboplatin-Paclitaxel followed by Dostarlimab Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has histologically or cytologically proven endometrial cancer with recurrent or advanced disease.
• Participant has molecular subtype of defective mismatch repair/microsatellite instability high (dMMR/MSI-H) or mismatch repair proficient/microsatellite stable (MMRp/MSS) determined.
• 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.
• 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).
• Participant has an Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0 or 1.
• Participant has adequate organ function, as assessed by hematologic, renal, hepatic and coagulation parameters.

You may not qualify if:

• 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.
• Participant has any medical history of interstitial lung disease or pneumonitis.
• Participant has cirrhosis or current unstable liver or biliary disease.
• Participant has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.
• Participant has a diagnosis of immunodeficiency.
• 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.
• Participant has not recovered adequately from AEs.
• 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.
• Participant has HBsAg positive, or HCV RNA positive.
• Participant is known HIV infection.
• 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.
• Participant with contraindication to carboplatin and paclitaxel.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (20)

GSK Investigational Site

Aichi, 464-8681, Japan

Location

GSK Investigational Site

Chiba, 260-8717, Japan

Location

GSK Investigational Site

Ehime, 791-0280, Japan

Location

GSK Investigational Site

Fukuoka, 811-1395, Japan

Location

GSK Investigational Site

Fukuoka, 830-0011, Japan

Location

GSK Investigational Site

Gunma, 373-8550, Japan

Location

GSK Investigational Site

Hokkaido, 060-8648, Japan

Location

GSK Investigational Site

Hyōgo, 673-8558, Japan

Location

GSK Investigational Site

Ibaraki, 305-8576, Japan

Location

GSK Investigational Site

Kanagawa, 259-1193, Japan

Location

GSK Investigational Site

Numakunai, 028-3695, Japan

Location

GSK Investigational Site

Okayama, 700-8558, Japan

Location

GSK Investigational Site

Osaka, 541-8567, Japan

Location

GSK Investigational Site

Osaka, 569-8686, Japan

Location

GSK Investigational Site

Saitama, 350-1298, Japan

Location

GSK Investigational Site

Shizuoka, 411-8777, Japan

Location

GSK Investigational Site

Tochigi, 329-0498, Japan

Location

GSK Investigational Site

Tokyo, 104-0045, Japan

Location

GSK Investigational Site

Tokyo, 135-8550, Japan

Location

GSK Investigational Site

Tokyo, 160-8582, Japan

Location

MeSH Terms

Conditions

Carcinoma; Endometrial Neoplasms

Interventions

dostarlimab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: May 7, 2024
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

JP (20)