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

Phase 4, Open Label, Non-comparative, Interventional, Multicenter Study to Evaluate the Safety of Dostarlimab in Adult Patients in India With Mismatch Repair Deficient (dMMR)/Microsatellite Instability-high (MSI-H) Recurrent or Advanced Endometrial Cancer (EC) That Has Progressed on or Following Prior Treatment With a Platinum-containing Regimen

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

Study Overview

• Status: Not yet recruiting
• Conditions: Neoplasms, Endometrial
• Intervention / Treatment: Drug: Dostarlimab

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: US GSK Clinical Trials Call Center; Phone Number: 877-379-3718; Email: GSKClinicalSupportHD@gsk.com
• Study Contact Backup: Name: EU GSK Clinical Trials Call Center; Phone Number: +44 (0) 20 89904466; Email: GSKClinicalSupportHD@gsk.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dostarlimab	Drug: Dostarlimab; Dostarlimab will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Grade 3 or greater Treatment Emergent Adverse Events (TEAEs)	Up to 25 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with any TEAEs	Up to 25 weeks
Number of Participants with Serious Adverse Events (SAEs), treatment related Adverse Events (AEs), treatment related SAEs, treatment related fatal AEs, non-fatal SAEs	Up to 25 weeks
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	Up to 25 weeks
Change from baseline in hematology parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelet count (Giga cells per Liter)	Baseline (Day 1) up to 25 weeks
Change from baseline in hematology parameter: Red Blood Cell (RBC) count (Trillion cells per Liter)	Baseline (Day 1) up to 25 weeks
Change from baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter)	Baseline (Day 1) up to 25 weeks
Change from baseline in hematology parameter: Reticulocytes (Percentage of reticulocytes)	Baseline (Day 1) up to 25 weeks
Change from baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters)	Baseline (Day 1) up to 25 weeks
Change from baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms)	Baseline (Day 1) up to 25 weeks
Change from baseline in clinical chemistry parameters: Blood urea nitrogen [BUN], glucose, calcium, sodium, and potassium levels (Millimoles per Liter)	Baseline (Day 1) up to 25 weeks
Change from baseline in clinical chemistry parameters: Total bilirubin, direct bilirubin and creatinine levels (Micromoles per Liter)	Baseline (Day 1) up to 25 weeks
Change from baseline in clinical chemistry parameters: Total protein levels (Gram per liter)	Baseline (Day 1) up to 25 weeks
Change from baseline in clinical chemistry parameters: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) levels (International units per liter)	Baseline (Day 1) up to 25 weeks
Change from Baseline in Vital signs: systolic blood pressure (SBP) and diastolic blood pressure (DBP) (Millimeters of mercury [mmHg])	Baseline (Day 1) up to 25 weeks
Change from Baseline in Vital signs: pulse rate (Beats per minute)	Baseline (Day 1) up to 25 weeks
Change from Baseline in Vital signs: body temperature (Degrees Celsius)	Baseline (Day 1) up to 25 weeks
Change from Baseline in Vital signs: respiratory rate (breaths per minute)	Baseline (Day 1) up to 25 weeks
Change from Baseline in electrocardiogram (ECG) values: Heart rate (Beats per minute)	Baseline (Day 1) up to 25 weeks

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2025
• Primary Completion (Estimated): January 13, 2027
• Study Completion (Estimated): January 13, 2027

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 4, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Endometrial cancer; Dostarlimab; dMMR; MSI-H
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Neoplasms; Endometrial Neoplasms; Antineoplastic Agents; Dostarlimab
• Other Study ID Numbers: 221460

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
• IPD Sharing Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• IPD Sharing Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes