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.
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.
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;
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.
Single group
Dostarlimab
Biological/VaccineDostarlimab will be administered.
Carboplatin
DrugCarboplatin will be administered.
Paclitaxel
DrugPaclitaxel 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).
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.
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.
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.
Overall survival (OS)
OS is defined as time from first dose of study intervention to death from any cause.
Click on the lead sponsor to view all of their trials.