Last updated: 07/04/2025 06:40:18

A study to evaluate the safety of dostarlimab in adult participants in India with recurrent or advanced endometrial cancer (EC)

GSK study ID
221460
Clinicaltrials.gov ID
NCT06897527
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official 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
Trial description: The goal of this study is to evaluate the safety profile of dostarlimab in Indian adults with recurrent or advanced endometrial cancer.
Primary purpose:
Treatment
Trial design:
Single Group
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

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

Timeframe: Up to 25 weeks

Secondary outcomes:

Number of Participants with any TEAEs

Timeframe: 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

Timeframe: 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

Timeframe: Up to 25 weeks

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

Timeframe: Baseline (Day 1) up to 25 weeks

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

Timeframe: Baseline (Day 1) up to 25 weeks

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

Timeframe: Baseline (Day 1) up to 25 weeks

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

Timeframe: Baseline (Day 1) up to 25 weeks

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

Timeframe: Baseline (Day 1) up to 25 weeks

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

Timeframe: 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)

Timeframe: Baseline (Day 1) up to 25 weeks

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

Timeframe: Baseline (Day 1) up to 25 weeks

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

Timeframe: 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)

Timeframe: 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])

Timeframe: Baseline (Day 1) up to 25 weeks

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

Timeframe: Baseline (Day 1) up to 25 weeks

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

Timeframe: Baseline (Day 1) up to 25 weeks

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

Timeframe: Baseline (Day 1) up to 25 weeks

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

Timeframe: Baseline (Day 1) up to 25 weeks

Interventions:
  • Drug: Dostarlimab
    • Enrollment:
    100
    Primary completion date:
    2027-13-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Neoplasms, Endometrial
    Product
    Dostarlimab
    Collaborators
    Not applicable
    Study date(s)
    July 2025 to January 2027
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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.
    • 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.
    Inclusion and exclusion 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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Will be recruiting
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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