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

NCT ID: NCT06897527

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2027-01-13

Brief Summary

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

Conditions

Neoplasms, Endometrial

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dostarlimab

Group Type: EXPERIMENTAL

Dostarlimab

Intervention Type: DRUG

Dostarlimab will be administered.

Interventions

Dostarlimab

Dostarlimab will be administered.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

US GSK Clinical Trials Call Center

Role: CONTACT

GSKClinicalSupportHD@gsk.com

877-379-3718

EU GSK Clinical Trials Call Center

Role: CONTACT

GSKClinicalSupportHD@gsk.com

+44 (0) 20 89904466

Other Identifiers

221460

Identifier Type: -

Identifier Source: org_study_id