A Study in Participants Previously Enrolled in a Genentech− and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A)

Official Title

An Open-Label, Multicentre Extension and Long-Term Observational Study in Patients Previously Enrolled in a Genentech− and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study

Summary:

This is an open-label, multicentre, 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 are eligible for continued treatment in the extension study. Dosing regimen for a given participant and indication will be according 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.

Trial Description

Primary Outcome:

  • Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s)
Secondary Outcome:
  • 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
  • Percentage of Participants With Adverse Events of Special Interest by Severity Determined According to NCI CTCAE Version 4.0
  • Time from Randomization or Treatment Initiation to Death due to any Cause

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society