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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dostarlimab-Carboplatin-Paclitaxel followed by Dostarlimab Monotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dostarlimab | Biological | Dostarlimab will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| DRR12 assessed by Investigator | 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 RECIST 1.1. | Up to approximately 148 weeks |
| Progression-free survival (PFS) per RECIST 1.1, assessed by BICR |
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Inclusion Criteria:
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:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Recruiting | Jinan | Shandong | 250117 | China |
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
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.
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.
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| Carboplatin | Drug | Carboplatin will be administered. |
|
| Paclitaxel | Drug | Paclitaxel will be administered. |
|
PFS is defined as the time from the date of first dose to the date of first documented disease progression (PD) or death due to any cause, whichever comes first. |
| Up to 226 weeks |
| Progression-free survival (PFS) per RECIST 1.1, assessed by investigator | PFS is defined as the time from the date of first dose to the date of first documented PD or death due to any cause, whichever comes first. | Up to 226 weeks |
| Overall survival (OS) | OS is defined as time from first dose of study intervention to death from any cause. | Up to 226 weeks |
| Overall response rate (ORR) per RECIST 1.1 assessed by BICR | ORR is defined as the proportion of participants with confirmed CR or PR. | Up to 226 weeks |
| ORR per RECIST 1.1 assessed by Investigator | ORR is defined as the proportion of participants with confirmed CR or PR. | Up to 226 weeks |
| Duration of response (DOR) per RECIST 1.1 assessed by BICR | DOR is defined as the time from the date of first documented objective response (confirmed CR or PR) to the date of first documented PD or death due to any cause, whichever comes first. | Up to 226 weeks |
| DOR per RECIST 1.1 assessed by Investigator | DOR is defined as the time from the date of first documented objective response (confirmed CR or PR) to the date of first documented PD or death due to any cause, whichever comes first. | Up to 226 weeks |
| Serum concentration of dostarlimab | Up to 67 weeks |
| Concentration at the end of infusion (C-EOI) for dostarlimab | Up to 67 weeks |
| Trough concentration (Ctrough) for dostarlimab | Up to 67 weeks |
| Number of participants with Anti-drug antibody (ADA) against dostarlimab | Up to 226 weeks |
| Number of participants with adverse events (AEs), Immune-mediated adverse events (imAEs), and serious adverse events (SAEs) by severity | Up to 226 weeks |
| Number of participants with AEs, imAEs, and SAEs leading to dose modifications or study intervention discontinuation | Up to 226 weeks |
| Number of participants with AEs leading to death | Up to 226 weeks |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C000719628 | dostarlimab |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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