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
概览
- 阶段
- 3 期
- 干预措施
- Bevacizumab
- 疾病 / 适应症
- Cancer
- 发起方
- Hoffmann-La Roche
- 入组人数
- 382
- 试验地点
- 294
- 主要终点
- Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s)
- 状态
- 进行中（未招募）
- 最后更新
- 19天前
概览
简要总结
This is an open-label, multicenter, non-randomized extension and long-term observational 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) and who continue to receive study treatment at the time of the parent-study closure and do not have access to the study treatment locally are eligible for continued treatment in the extension study. Dosing regimen for a given participant and indication will be the same or equivalent to the respective parent study protocol. Study treatment in the extension study can continue until disease progression or beyond if the patient 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; patient non-compliance; or study termination by the Sponsor, whichever occurs first.
研究者
入排标准
入选标准
- •Specific criteria for patients who continue treatment as well as safety and survival follow-up in the extension study (and survival follow up for pattients 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
- •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
- •Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of parent-study closure as assessed by the investigator
- •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 and 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, or 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
- •Specific criteria for patients who continue treatment as well as safety and survival follow-up in the extension study:
- •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
- •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 SAE(s) that has not resolved to baseline level or Grade less than or equal to (\<=) 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
- •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 participant at high risk for treatment-related complications
- •Concurrent participation in any therapeutic clinical trial (other than the parent study)
研究组 & 干预措施
Combined Agents with Atezolizumab
Participants will receive treatment of atezolizumab with combined agent(s) as directed per the parent study. Participants will receive agent(s) in combination with atezolizumab at the same dose and schedule, and with the same administration guidelines that were in effect at the time of participant discontinuation from the parent study.
干预措施: Bevacizumab
Combined Agents with Atezolizumab
Participants will receive treatment of atezolizumab with combined agent(s) as directed per the parent study. Participants will receive agent(s) in combination with atezolizumab at the same dose and schedule, and with the same administration guidelines that were in effect at the time of participant discontinuation from the parent study.
干预措施: Atezolizumab
Atezolizumab Monotherapy
Participants will continue to receive atezolizumab monotherapy in a Genentech or Roche-sponsored study (the parent study) in accordance with local prescribing information till the participant continues to derive clinical benefit or 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
Comparator Treatment
Participants will receive comparator treatment administration as directed per the parent study. Participants will receive comparator treatment at the same dose and schedule, and with the same administration guidelines that were in effect at the time of participant discontinuation from the parent study.
干预措施: Bevacizumab
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: Day 1 up to maximum 10 years
次要结局
- Percentage of Participants With Serious Adverse Events (SAEs) by Severity Determined According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0(Day 1 up to 90 days after last dose of study treatment (last dose=till clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years))
- Percentage of Participants With Adverse Events of Special Interest by Severity Determined According to NCI CTCAE Version 4.0(Day 1 up to 90 days after last dose of study treatment (last dose=till clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years))
- Percentage of Participants With Serious Adverse Events (SAEs) by Severity Determined According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0(Day 1 up to 90 days after last dose of study treatment (last dose=till clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years))
- Percentage of Participants With Adverse Events of Special Interest by Severity Determined According to NCI CTCAE Version 4.0(Day 1 up to 90 days after last dose of study treatment (last dose=till clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years))
- Time from Randomization or Treatment Initiation to Death due to any Cause for IMpower133 Participants Only(Day 1 (as indicated in parent study protocol) until death due to any cause (up to maximum 10 years or until the sponsor stop))