The goal of this study is to evaluate the safety profile of dostarlimab in Indian adults with recurrent or advanced endometrial cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Dostarlimab will be administered.
Number of Participants with Grade 3 or greater Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 25 weeks
Number of Participants with any TEAEs
Time frame: 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
Time frame: 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
Time frame: Up to 25 weeks
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
Change from baseline in hematology parameter: Red Blood Cell (RBC) count (Trillion cells per Liter)
Time frame: Baseline (Day 1) up to 25 weeks
Change from baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter)
Time frame: Baseline (Day 1) up to 25 weeks
Change from baseline in hematology parameter: Reticulocytes (Percentage of reticulocytes)
Time frame: Baseline (Day 1) up to 25 weeks
Change from baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters)
Time frame: Baseline (Day 1) up to 25 weeks
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Change from baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms)
Time frame: 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)
Time frame: Baseline (Day 1) up to 25 weeks
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
Change from baseline in clinical chemistry parameters: Total protein levels (Gram per liter)
Time frame: 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)
Time frame: 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])
Time frame: Baseline (Day 1) up to 25 weeks
Change from Baseline in Vital signs: pulse rate (Beats per minute)
Time frame: Baseline (Day 1) up to 25 weeks
Change from Baseline in Vital signs: body temperature (Degrees Celsius)
Time frame: Baseline (Day 1) up to 25 weeks
Change from Baseline in Vital signs: respiratory rate (breaths per minute)
Time frame: Baseline (Day 1) up to 25 weeks
Change from Baseline in electrocardiogram (ECG) values: Heart rate (Beats per minute)
Time frame: Baseline (Day 1) up to 25 weeks