Clinical trial NCT06897527: A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Recurrent or Advanced Endometrial Cancer (EC)
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Neoplasms, Endometrial
Keywords: Dostarlimab
Endometrial cancer
dMMR
MSI-H
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2025-03-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Number of Participants with Grade 3 or greater Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 25 weeks
Secondary outcomes:
measure: Number of Participants with any TEAEs
timeFrame: Up to 25 weeks
measure: 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
measure: 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
measure: 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
measure: Change from baseline in hematology parameter: Red Blood Cell (RBC) count (Trillion cells per Liter)
timeFrame: Baseline (Day 1) up to 25 weeks
measure: Change from baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter)
timeFrame: Baseline (Day 1) up to 25 weeks
measure: Change from baseline in hematology parameter: Reticulocytes (Percentage of reticulocytes)
timeFrame: Baseline (Day 1) up to 25 weeks
measure: Change from baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters)
timeFrame: Baseline (Day 1) up to 25 weeks
measure: Change from baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms)
timeFrame: Baseline (Day 1) up to 25 weeks
measure: 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
measure: 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
measure: Change from baseline in clinical chemistry parameters: Total protein levels (Gram per liter)
timeFrame: Baseline (Day 1) up to 25 weeks
measure: 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
measure: 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
measure: Change from Baseline in Vital signs: pulse rate (Beats per minute)
timeFrame: Baseline (Day 1) up to 25 weeks
measure: Change from Baseline in Vital signs: body temperature (Degrees Celsius)
timeFrame: Baseline (Day 1) up to 25 weeks
measure: Change from Baseline in Vital signs: respiratory rate (breaths per minute)
timeFrame: Baseline (Day 1) up to 25 weeks
measure: Change from Baseline in electrocardiogram (ECG) values: Heart rate (Beats per minute)
timeFrame: Baseline (Day 1) up to 25 weeks
Other outcomes:
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Study officials:
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