An Extension Study in Participants Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella C)
Phase 3
Active, not recruiting
- Conditions
- Neoplasms
- Interventions
- Registration Number
- NCT05112965
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 49
Inclusion Criteria
- 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
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Exclusion Criteria
- 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 (Β±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 β€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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combined Agents with Atezolizumab 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. Comparator Treatment Pemetrexed 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. Combined Agents with Atezolizumab Bevacizumab 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. Combined Agents with Atezolizumab Paclitaxel 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. Atezolizumab Monotherapy Atezolizumab 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. Combined Agents with Atezolizumab Pemetrexed 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. Combined Agents with Atezolizumab Enzalutamide 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. Comparator Treatment Bevacizumab 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. Comparator Treatment Paclitaxel 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. Comparator Treatment Enzalutamide 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Continued Access to Atezolizumab-based Therapy and/or Comparator Agent(s) Up to approximately 4 years
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (19)
Shanghai Chest Hospital
π¨π³Shanghai, China
Tianjin Cancer Hospital
π¨π³Tianjin, China
Zhongshan Hospital Fudan University
π¨π³Shanghai, China
The 2nd Hospital of Tianjin Medical University
π¨π³Tianjin, China
Zhejiang Cancer Hospital
π¨π³Zhejiang, China
Peking Union Medical College Hospital
π¨π³Beijing City, China
Beijing Cancer Hospital
π¨π³Beijing, China
The First Affiliated Hospital of Guangzhou Medical University
π¨π³Guangzhou, China
Nanfang Hospital, Southern Medical University
π¨π³Guangzhou, China
Sir Run Run Shaw Hospital
π¨π³Hangzhou City, China
Harbin Medical University Cancer Hospital
π¨π³Harbin, China
Changchun Cancer Hospital
π¨π³Changchun, China
The 900th Hospital of PLA joint service support force
π¨π³Fuzhou, China
Jiangsu Cancer Hospital
π¨π³Nanjing City, China
Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
π¨π³Wuhan, China
Henan Cancer Hospital
π¨π³Zhengzhou, China
Jilin Cancer Hospital
π¨π³Changchun, China
Hunan Cancer Hospital
π¨π³Changsha CITY, China
Shandong Cancer Hospital
π¨π³Jinan, China