A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Recurrent or Advanced Endometrial Cancer (EC)

Официальное название

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

Обзор

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

Вмешательства

• Препарат Dostarlimab
  Dostarlimab will be administered.

Первичные конечные точки

• Number of Participants with Grade 3 or greater Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Up to 25 weeks]

Вторичные конечные точки (12)

• Number of Participants with any TEAEs [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Up to 25 weeks]
• Change from baseline in hematology parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelet count (Giga cells per Liter) [Срок оценки: Baseline (Day 1) up to 25 weeks]
• Change from baseline in hematology parameter: Red Blood Cell (RBC) count (Trillion cells per Liter) [Срок оценки: Baseline (Day 1) up to 25 weeks]
• Change from baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter) [Срок оценки: Baseline (Day 1) up to 25 weeks]
• Change from baseline in hematology parameter: Reticulocytes (Percentage of reticulocytes) [Срок оценки: Baseline (Day 1) up to 25 weeks]
• Change from baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters) [Срок оценки: Baseline (Day 1) up to 25 weeks]
• Change from baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms) [Срок оценки: 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) [Срок оценки: Baseline (Day 1) up to 25 weeks]
• Change from baseline in clinical chemistry parameters: Total bilirubin, direct bilirubin and creatinine levels (Micromoles per Liter) [Срок оценки: Baseline (Day 1) up to 25 weeks]
• Change from baseline in clinical chemistry parameters: Total protein levels (Gram per liter) [Срок оценки: Baseline (Day 1) up to 25 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06897527 · 221460

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗