A Phase 2 interventional study of Dostarlimab and Carboplatin in Neoplasms, Endometrial, sponsored by GlaxoSmithKline. Recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
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.
1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.
This study's planned enrollment of 30 is below the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
Biological: Dostarlimab · Drug: Carboplatin · Drug: Paclitaxel
Dostarlimab will be administered.
Carboplatin will be administered.
Paclitaxel will be administered.
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).
Time frame: Up to approximately 148 weeks
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.
Time frame: Up to approximately 148 weeks
Progression-free survival (PFS) per RECIST 1.1, assessed by BICR
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.
Time frame: 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.
Time frame: Up to 226 weeks
Overall survival (OS)
OS is defined as time from first dose of study intervention to death from any cause.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 226 weeks
Serum concentration of dostarlimab
Time frame: Up to 67 weeks
Concentration at the end of infusion (C-EOI) for dostarlimab
Time frame: Up to 67 weeks
Trough concentration (Ctrough) for dostarlimab
Time frame: Up to 67 weeks
Number of participants with Anti-drug antibody (ADA) against dostarlimab
Time frame: Up to 226 weeks
Number of participants with adverse events (AEs), Immune-mediated adverse events (imAEs), and serious adverse events (SAEs) by severity
Time frame: Up to 226 weeks
Number of participants with AEs, imAEs, and SAEs leading to dose modifications or study intervention discontinuation
Time frame: Up to 226 weeks
Number of participants with AEs leading to death
Time frame: Up to 226 weeks
Plan to share: Yes — 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
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
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