An Extension Study in Participants Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella C)
- Sponsor
- Hoffmann-La Roche
- Study ID
- NCT05112965
- Phase
- PHASE3
- Status
- Active Not Recruiting
Conditions
- Neoplasms
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Atezolizumab — DRUGAtezolizumab will be administered as a monotherapy or atezolizumab with other agent(s) as per parent protocol. Dosing regimen will continue in accordance with the parent study or at equivalent dose (if applicable) and at the same schedule as the parent study at the time of participant discontinuation from the parent study closure.
- Bevacizumab — DRUGBevacizumab will be administered as directed per the parent study.
- Pemetrexed — DRUGPemetrexed will be administered as directed per the parent study.
- Paclitaxel — DRUGPaclitaxel will be administered as directed per the parent study.
- Enzalutamide — DRUGEnzalutamide will be administered as directed per the parent study.
Study Details
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.
Key Dates
- Start date
- Dec 1, 2021
- Status verified
- Apr 2026
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 49 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Atezolizumab MonotherapyParticipants 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.
- Experimental: Combined Agents with AtezolizumabParticipants 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.
- Active Comparator: Comparator TreatmentParticipants 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 Measure
Number of Participants With Continued Access to Atezolizumab-based Therapy and/or Comparator Agent(s) [ Time Frame: Up to approximately 4 years ]
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