A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Chinese Participants With Primary Advanced or Recurrent Endometrial Cancer (EC)

NCT07108270 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 222258
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to see how well dostarlimab works when administered with the chemotherapy drugs carboplatin and paclitaxelin in treating EC in Chinese participants. The study aims to understand the treatments effectiveness, safety, how the drugs behave in the body, and whether it causes any immune reactions.

Conditions

Neoplasms, Endometrial

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 confirmed Complete Response (CR) or Partial Response (PR), and Duration of Response (DOR) lasting greater than or equal to (≥) 12 months, per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).

  Up to approximately 148 weeks

Secondary Outcomes (15)

• DRR12 assessed by Investigator

  Up to approximately 148 weeks

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

  Up to 226 weeks

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

  Up to 226 weeks

• Overall survival (OS)

  Up to 226 weeks

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

  Up to 226 weeks

Study Arms (1)

Dostarlimab-Carboplatin-Paclitaxel followed by Dostarlimab Monotherapy

EXPERIMENTAL

Biological: Dostarlimab; Drug: Carboplatin; Drug: Paclitaxel

Interventions

Dostarlimab BIOLOGICAL

Dostarlimab will be administered.

Dostarlimab-Carboplatin-Paclitaxel followed by Dostarlimab Monotherapy

Carboplatin DRUG

Carboplatin will be administered.

Dostarlimab-Carboplatin-Paclitaxel followed by Dostarlimab Monotherapy

Paclitaxel DRUG

Paclitaxel will be administered.

Dostarlimab-Carboplatin-Paclitaxel followed by Dostarlimab Monotherapy

Eligibility Criteria

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

You may qualify if:

• Participant has histologically or cytologically proven EC with recurrent or advanced disease.
• Participant has molecular subtype of defective mismatch repair (dMMR) or microsatellite instability high (MSI-H) determined by the central reference laboratory before study intervention.
• Participant must have primary Stage III or Stage IV disease or first recurrent EC with a low potential for cure by radiation therapy or surgery alone or in combination, and presence of at least one target lesion per RECIST 1.1 based on Investigator's assessment and meet at least 1 of the following criteria:
• Has primary Stage III to IV disease and is naive to systemic anticancer therapy for EC;
• Has first recurrent disease and is naïve to systemic anticancer therapy for EC;
• Had received prior neo-adjuvant/adjuvant anticancer therapy and had a recurrence or PD ≥6 months after completing treatment (first recurrence only).
• Participant has adequate archive tumor tissue sample for MMR/MSI status testing. If no archival tissue is available, tissue sample must be obtained before study intervention.
• 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 prior to the first dose of study intervention.
• Participant has Hepatitis B surface antigen (HBsAg) positive, or Hepatitis C virus (HCV) Ribonucleic acid (RNA) positive at screening or within 3 months prior to the first dose of study intervention.
• Participant is known human immunodeficiency virus (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 (1)

GSK Investigational Site

Jinan, Shandong, 250117, China

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

dostarlimab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; 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

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

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: August 5, 2025
• First Posted: August 7, 2025
• Study Start: November 27, 2025
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2030
• Last Updated: December 22, 2025

Record last verified: 2025-12

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 asset(s) with development terminated 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

CN (1)