A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Recurrent or Advanced Endometrial Cancer (EC)

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGlaxoSmithKline

About this trial

The goal of this study is to evaluate the safety profile of dostarlimab in Indian adults with recurrent or advanced endometrial cancer.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Dostarlimab

Treatment groups

100 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators