CTRI/2025/04/085913招募中4 期
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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 16
- 主要终点
- Proportion of incidence of Grade 3 or greater TEAEs up to 25 weeks
研究概览
简要总结
The current Phase 4 study has been planned with the objective to evaluate the safety profile of dostarlimab treatment in adult patients in India with dMMR/MSI-H recurrent or advanced EC that had progressed on or following prior treatment with a platinum-containing regimen over the 25 weeks (175 days) of study participation by assessing the incidence of TEAEs and proportion of SAEs and possible TEAEs leading to death, dose modification, or treatment discontinuation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •AGE: 1.18 years of age and above, at the time of signing the informed consent.
- •TYPE OF PATIENT AND DISEASE CHARACTERISTICS
- •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.
- •INFORMED CONSENT
- •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.
排除标准
- •Medical conditions
- •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.
- •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
- •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.
- •Prior/Concurrent clinical study experience
- •Participation in another clinical study with a study drug administered in the last 3 months.
- •Diagnostic assessments
- •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
- •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.
结局指标
主要结局
Proportion of incidence of Grade 3 or greater TEAEs up to 25 weeks
时间窗: weeks 25
次要结局
- 1. Incidence of TEAEs up to 25 weeks.(2. Incidence of SAEs, related AEs and SAEs,)
研究者
Dr Gaurav Deshmukh
GSK
研究点 (16)
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