A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study

  • Interventional
  • Recruiting
  • NCT03768063
Eligibility Details Visit Clinicaltrials.gov

An Open Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella B)

This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or comparator agent(s) during participation in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and who do not have access to the study treatment locally, may continue to receive study treatment in this extension study following roll-over from the parent study.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Eligible for continuing atezolizumab-based therapy at the time of roll-over 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

         - Time between the last dose of treatment received in parent study and first dose in extension study is no longer than the interruption period allowed in the parent study. 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 roll-over 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

        Exclusion Criteria:

         - Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study

         - Study treatment or comparator agent is commercially marketed in the patient's country for the patient-specific disease and is accessible to the patient

         - 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 this extension study (if applicable)

         - Ongoing serious adverse event(s) that has 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 this extension study

         - Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or 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 this extension study and for the period after the last dose of study treatment specified in the designated referenced safety information (RSI)

At a Glance

National Government IDNCT03768063

IRB#IRB18-1799

Lead SponsorHoffmann-La Roche

Lead PhysicianGini Fleming

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting