Health Condition 1: C541- Malignant neoplasm of endometrium
Conditions
Interventions
Intervention1: Dostarlimab concentrate for solution for infusion 500 mg/10 mL: Unit Dose Strength: One vial of 500mg concentrate for solution for infusion 500mg/10ml.
Dosage and Frequency: In the cur
Sponsors
GlaxosmithKline
Eligibility
Inclusion criteria
Inclusion criteria: AGE: 1.18 years of age and above, at the time of signing the informed consent. TYPE OF PATIENT AND DISEASE CHARACTERISTICS 2. Documented case of dMMR/MSI-H recurrent or advanced EC that has progressed on or following prior treatment with platinum containing regimen. 3. Eligible for dostarlimab treatment according to the approved prescribing information and the investigatorââ?¬•s clinical judgement. 4. WOCBP (Women of childbearing potential) agree to use contraceptive from screening through at least 120 days after the last dose. 5. Negative serum or urine pregnancy test at most 72 hours prior to the first dose of study medication. INFORMED CONSENT 6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol, in accordance with applicable laws.
Exclusion criteria
Exclusion criteria: Medical conditions 1. Known active hepatic disease, ESRD or known case of serious, uncontrolled medical disorder/active infections which precludes participant inclusion in the study as per the investigators judgement. 2. 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. Prior/Concomitant therapy 3. Received prior therapy with an anti- programmed death receptor 1 (anti-PD-1), anti-PD-1- ligand-1 (anti-PD-L1) agent. 4. 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. 5. Received a live vaccine within 14 days of planned start of study therapy. Prior/Concurrent clinical study experience 6. Participation in another clinical study with a study drug administered in the last 3 months. Diagnostic assessments 7. Pregnant, breastfeeding, or expecting to conceive while receiving study treatment and for up to 120 days after the last dose of study treatment. Other exclusion criteria 8. 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 |
|---|---|
| Proportion of incidence of Grade 3 or greater TEAEs up to 25 weeksTimepoint: weeks 25 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of TEAEs up to 25 weeks. 2. Incidence of SAEs, related AEs and SAEs, fatal AEs, non-fatal SAEs, AEs leading to discontinuation of treatment, AEs leading to death, AEs leading to withdrawal and dose modification up to 25 weeks. 3. Change in laboratory parameters (hematology and clinical chemistry), vital signs and ECG from baseline at week 25.Timepoint: Weeks 25 | — |
Countries
India
Contacts
Public ContactDr Gaurav Deshmukh
GSK
Outcome results
None listed