Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06897527

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dostarlimab

Drug

Dostarlimab will be administered.

Primary outcomes

  1. Number of Participants with Grade 3 or greater Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 25 weeks

Secondary outcomes

  1. Number of Participants with any TEAEs

    Time frame: Up to 25 weeks

  2. Number of Participants with Serious Adverse Events (SAEs), treatment related Adverse Events (AEs), treatment related SAEs, treatment related fatal AEs, non-fatal SAEs

    Time frame: Up to 25 weeks

  3. 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

    Time frame: Up to 25 weeks

  4. Change from baseline in hematology parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelet count (Giga cells per Liter)

    Time frame: Baseline (Day 1) up to 25 weeks

  5. Change from baseline in hematology parameter: Red Blood Cell (RBC) count (Trillion cells per Liter)

    Time frame: Baseline (Day 1) up to 25 weeks

  6. Change from baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter)

    Time frame: Baseline (Day 1) up to 25 weeks

  7. Change from baseline in hematology parameter: Reticulocytes (Percentage of reticulocytes)

    Time frame: Baseline (Day 1) up to 25 weeks

  8. Change from baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters)

    Time frame: Baseline (Day 1) up to 25 weeks

  9. Change from baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms)

    Time frame: Baseline (Day 1) up to 25 weeks

  10. Change from baseline in clinical chemistry parameters: Blood urea nitrogen [BUN], glucose, calcium, sodium, and potassium levels (Millimoles per Liter)

    Time frame: Baseline (Day 1) up to 25 weeks

  11. Change from baseline in clinical chemistry parameters: Total bilirubin, direct bilirubin and creatinine levels (Micromoles per Liter)

    Time frame: Baseline (Day 1) up to 25 weeks

  12. Change from baseline in clinical chemistry parameters: Total protein levels (Gram per liter)

    Time frame: Baseline (Day 1) up to 25 weeks

  13. Change from baseline in clinical chemistry parameters: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) levels (International units per liter)

    Time frame: Baseline (Day 1) up to 25 weeks

  14. Change from Baseline in Vital signs: systolic blood pressure (SBP) and diastolic blood pressure (DBP) (Millimeters of mercury [mmHg])

    Time frame: Baseline (Day 1) up to 25 weeks

  15. Change from Baseline in Vital signs: pulse rate (Beats per minute)

    Time frame: Baseline (Day 1) up to 25 weeks

  16. Change from Baseline in Vital signs: body temperature (Degrees Celsius)

    Time frame: Baseline (Day 1) up to 25 weeks

  17. Change from Baseline in Vital signs: respiratory rate (breaths per minute)

    Time frame: Baseline (Day 1) up to 25 weeks

  18. Change from Baseline in electrocardiogram (ECG) values: Heart rate (Beats per minute)

    Time frame: Baseline (Day 1) up to 25 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

EU GSK Clinical Trials Call Center

CONTACT

[email protected]

+44 (0) 20 89904466

US GSK Clinical Trials Call Center

CONTACT

[email protected]

877-379-3718

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.