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

GlaxoSmithKline (GSK)

Status and phase: Not yet enrolling; Phase 4

Conditions: Neoplasms, Endometrial

Treatments: Drug: Dostarlimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06897527

221460

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Dostarlimab

Experimental group

Treatment:

Drug: Dostarlimab