Neoplasms, Endometrial
Conditions
Keywords
Dostarlimab, Endometrial cancer, dMMR, MSI-H
Brief summary
The goal of this study is to evaluate the safety profile of dostarlimab in Indian adults with recurrent or advanced endometrial cancer.
Interventions
DRUGDostarlimab
Dostarlimab will be administered.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Grade 3 or greater Treatment Emergent Adverse Events (TEAEs) | Up to 25 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Number of Participants with any TEAEs | 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 |
| 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 |
Contacts
Primary ContactUS GSK Clinical Trials Call Center
Backup ContactEU GSK Clinical Trials Call Center
Outcome results
None listed