2023-506184-34-00招募中3 期
An open label, multicenter extension study in patients previously enrolled in a Genentch and/or F. Hoffmann-La Roche Ltd sponsored atezolizumab study (IMBRELLA B)
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 34
- 主要终点
- Patients who are deriving clinical benefit from the treatment with atezolizumab-based therapy and/or comparator agent(s) according to investigator assessment.
研究概览
简要总结
To provide continued treatment with atezolizumab-based therapy and/or combination/comparator agent(s) for eligible patients still on study treatment at the time of roll-over from the parent study who do not have access to the study treatment locally
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Signed extension study Informed Consent Form
- •Eligible for continuing atezolizumab-based therapy at the time of rollover from the parent study, as per the parent study protocol or
- •Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study as per the parent study protocol, with no access to commercially available comparator agent
- •Time between the last dose of treatment received in parent study and first dose in extension study is no longer than the interruption period allowed in the parent study. First dose of study treatment in this extension study will be received within 7 days of the treatment interruption window allowed by the parent study
- •Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of roll-over from the parent study as assessed by the investigator
- •Able to comply with this extension study, in the investigator's judgment
- •Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential
- •Will comply with contraception criteria
排除标准
- •Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrolment in this extension study
- •Study treatment or comparator agent is commercially marketed in the patient's country for the patient-specific disease and is accessible to the patient
- •Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in this extension study
- •Permanent discontinuation of atezolizumab for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable) Exception: Patients who permanently discontinued atezolizumab from parent studies that permit patients to continue treatment with the combination agent(s) alone after permanently discontinuing atezolizumab are eligible to enroll in this study.
- •Ongoing serious adverse event(s) that has not resolved to baseline level or Grade ≤1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study
- •Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications
- •Concurrent participation in any therapeutic clinical trial (other than the parent study)
- •Pregnant or lactating, or intending to become pregnant during this extension study and for the period after the last dose of study treatment specified in the designated RSI
结局指标
主要结局
Patients who are deriving clinical benefit from the treatment with atezolizumab-based therapy and/or comparator agent(s) according to investigator assessment.
Patients who are deriving clinical benefit from the treatment with atezolizumab-based therapy and/or comparator agent(s) according to investigator assessment.
次要结局
未报告次要终点
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (34)
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