An Open-Label, Multicenter Extension Study in Participants Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella C)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 49
- 试验地点
- 27
- 主要终点
- Number of Participants With Continued Access to Atezolizumab-based Therapy and/or Comparator Agent(s)
研究概览
简要总结
This is an open-label, multicenter, non-randomized extension study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and do not have access to the study treatment locally, continue to receive study treatment in this extension study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for continuing or crossing over to 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
- •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 rollover from the parent study as assessed by the investigator
- •Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential
- •For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggs
- •For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
排除标准
- •Meet 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
- •Time between the last dose of treatment received in parent study and first dose in extension study is longer than the interruption period (±7 days) allowed in the parent 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
- •Ongoing serious adverse events that have 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 the extension study
- •Any serious uncontrolled concomitant disease that would contraindicate the use of study treatment at the time of the extension study or that would 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 the extension study
研究组 & 干预措施
Combined Agents with Atezolizumab
Participants will continue to receive atezolizumab with other agent(s) as per parent protocol, until disease progression or beyond if the participant continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; participant non-compliance; or study termination by the Sponsor, whichever occurs first.
干预措施: Pemetrexed (Drug)
Combined Agents with Atezolizumab
Participants will continue to receive atezolizumab with other agent(s) as per parent protocol, until disease progression or beyond if the participant continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; participant non-compliance; or study termination by the Sponsor, whichever occurs first.
干预措施: Paclitaxel (Drug)
Atezolizumab Monotherapy
Participants will continue to receive atezolizumab monotherapy as per parent protocol, until disease progression or beyond if the participant continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; participant non-compliance; or study termination by the Sponsor, whichever occurs first.
干预措施: Atezolizumab (Drug)
Combined Agents with Atezolizumab
Participants will continue to receive atezolizumab with other agent(s) as per parent protocol, until disease progression or beyond if the participant continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; participant non-compliance; or study termination by the Sponsor, whichever occurs first.
干预措施: Bevacizumab (Drug)
Combined Agents with Atezolizumab
Participants will continue to receive atezolizumab with other agent(s) as per parent protocol, until disease progression or beyond if the participant continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; participant non-compliance; or study termination by the Sponsor, whichever occurs first.
干预措施: Atezolizumab (Drug)
Combined Agents with Atezolizumab
Participants will continue to receive atezolizumab with other agent(s) as per parent protocol, until disease progression or beyond if the participant continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; participant non-compliance; or study termination by the Sponsor, whichever occurs first.
干预措施: Enzalutamide (Drug)
Comparator Treatment
Participants will continue to receive comparator agent(s) as per parent protocol, until disease progression or beyond if the participant continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; participant non-compliance; or study termination by the Sponsor, whichever occurs first.
干预措施: Bevacizumab (Drug)
Comparator Treatment
Participants will continue to receive comparator agent(s) as per parent protocol, until disease progression or beyond if the participant continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; participant non-compliance; or study termination by the Sponsor, whichever occurs first.
干预措施: Paclitaxel (Drug)
Comparator Treatment
Participants will continue to receive comparator agent(s) as per parent protocol, until disease progression or beyond if the participant continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; participant non-compliance; or study termination by the Sponsor, whichever occurs first.
干预措施: Pemetrexed (Drug)
Comparator Treatment
Participants will continue to receive comparator agent(s) as per parent protocol, until disease progression or beyond if the participant continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; participant non-compliance; or study termination by the Sponsor, whichever occurs first.
干预措施: Enzalutamide (Drug)
结局指标
主要结局
Number of Participants With Continued Access to Atezolizumab-based Therapy and/or Comparator Agent(s)
时间窗: Up to approximately 4 years
次要结局
- Percentage of Participants With Adverse Events of Special Interest (AESIs)(Up to 90 days after the final dose of study treatment (up to approximately 4 years))
- Percentage of Participants With Serious Adverse Events (SAEs)(Up to 90 days after the final dose of study treatment (up to approximately 4 years))