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

Launched by GLAXOSMITHKLINE · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a medication called dostarlimab in adult women in India who have recurrent or advanced endometrial cancer, a type of cancer that affects the lining of the uterus. The researchers want to find out how safe this treatment is for people who have already received other therapies that didn't work for them. The trial is not yet recruiting participants, but it aims to include women aged 18 and older who have a specific type of cancer that has progressed after previous treatments.

To be eligible for this study, participants must have a confirmed diagnosis of specific cancer characteristics and must be willing to follow certain guidelines, such as using contraception if they are able to become pregnant and agreeing to regular health check-ups throughout the trial. It’s important to note that people with certain serious health issues, those who have received similar treatments before, or those who are pregnant or breastfeeding cannot participate. If you or someone you know might be interested in this trial, it could be a chance to access a new treatment option while helping researchers learn more about it.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • Negative serum or urine pregnancy test at most 72 hours prior to the first dose of study medication.
• • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol, in accordance with applicable laws.
• Exclusion Criteria:
• • 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.
• • Received a live vaccine within 14 days of planned start of study therapy.
• • Participation in another clinical study with a study drug administered in the last 3 months.
• • Pregnant, breastfeeding, or expecting to conceive while receiving study treatment and for up to 120 days after the last dose of study treatment.
• • Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.