2023-506186-57-00招募中3 期
An Open-Label, Multicenter Extension and Long-Term Observational Study in Patients Previously Enrolled in a Genentech-and/Or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 99
- 试验地点
- 9
- 主要终点
- N/A (Not Applicable)
研究概览
简要总结
To provide continued access to atezolizumab-based therapy and/or comparator agent(s) for eligible patients still on study treatment at the time of the parent-study closure and who do not have access to the study treatment locally
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Specific criteria for patients who continue treatment as well as safety follow-up in the extension study (and survival follow up for patients who roll over from IMpower133): Eligible for continuing or crossing over to atezolizumab-based therapy at the time of the parent-study closure as per the parent study or Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study at the time of the parent-study closure as per the parent study, with no access to commercially available comparator agent.
- •Specific criteria for patients who continue treatment as well as safety follow-up in the extension study (and survival follow up for patients who roll over from IMpower133): First dose of study treatment in the extension study will be received within 7 days of the treatment interruption window allowed by the parent study.
- •Specific criteria for patients who continue treatment as well as safety follow-up in the extension study (and survival follow up for patients who roll over from IMpower133): Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of parent-study closure as assessed by the investigator.
- •Specific criteria for patients who continue treatment as well as safety follow-up in the extension study (and survival follow up for patients who roll over from IMpower133): Able to comply with the 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.
- •Specific criteria for patients from the IMpower133 parent study only who do not continue treatment in the extension study and/or receive commercially available atezolizumab (Tecentriq®) outside this extension study but continue safety and survival follow-up only in the extension study: Discontinuation of atezolizumab-based therapy in the IMpower133 parent study and in survival follow-up at the time of IMpower133 parent study closure
- •Specific criteria for patients from the IMpower133 parent study only who do not continue treatment in the extension study and/or receive commercially available atezolizumab (Tecentriq®) outside this extension study but continue safety and survival follow-up only in the extension study: Eligible for continuing or crossing over to atezolizumab-based therapy as per the IMpower133 parent protocol and have access to commercially available atezolizumab (Tecentriq®) outside this extension study at the time of the IMpower133 parent-study closure.
排除标准
- •Meet of any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in the extension study
- •Study treatment is commercially marketed in the patient’s country for the patient-specific disease and is accessible to the patient.
- •Ongoing serious adverse event(s) that has not resolved to baseline level or Grade<=1 from the parent study or during the time between last treatment in the parent study and the first dose of study treatment in the extension study
- •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 the 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 the extension study (if applicable)
- •Any unresolved or irreversible toxicities during the parent study that required permanent discontinuation of study treatment, in accordance to the parent study or local prescribing information
结局指标
主要结局
N/A (Not Applicable)
N/A (Not Applicable)
次要结局
- Incidence and severity of serious adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.0
- Incidence and severity of adverse events of special interest, with severity determined according to NCI CTCAE, v4.0
- Time from randomization or treatment initiation (as indicated in parent study protocol) to death due to any cause (For patients from Impower 133 only)
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (9)
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