The goal of this study is to evaluate the safety profile of dostarlimab in Indian adults with recurrent or advanced endometrial cancer.
Participants ≥18 years of age, at the time of signing the informed consent.
Documented case of dMMR/MSI-H recurrent or advanced EC that has progressed on or following prior treatment with platinum containing regimen.
Eligible for dostarlimab treatment according to the approved prescribing information and the investigator's clinical judgement.
WOCBP (Women of childbearing potential) agree to use contraceptive from screening through at least 120 days after the last dose.
Known active hepatic disease, End-Stage Renal Disease (ESRD) or known case of serious, uncontrolled medical disorder/active infections which precludes participant's inclusion in the study as per the investigator's judgement.
Either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class of the study drug.
Received prior therapy with an anti- programmed death receptor 1 (anti-PD-1), anti-PD-1- ligand-1 (anti-PD-L1) agent.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
Single group
Dostarlimab
DrugDostarlimab will be administered.
Number of Participants with Grade 3 or greater Treatment Emergent Adverse Events (TEAEs)
Number of Participants with any TEAEs
Number of Participants with Serious Adverse Events (SAEs), treatment related Adverse Events (AEs), treatment related SAEs, treatment related fatal AEs, non-fatal SAEs
Number of Participants with AEs leading to discontinuation of treatment, AEs leading to death, AEs leading to study withdrawal and AEs leading to dose modification
Change from baseline in hematology parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelet count (Giga cells per Liter)
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: