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
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
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.
Inclusion Criteria:
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):
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
Exclusion Criteria:
Specific criteria for patients who continue treatment as well as safety and survival follow-up in the extension study:
Specific criteria for patients 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 comparator in parent study and in survival follow-up at the time of parent study closure
Washington D.C., District of Columbia 20057, United States
Marietta, Georgia 30060, United States
Praha 4 - Krc, 140 59, Czechia
Naples, Campania 80131, Italy
Siena, Tuscany 53100, Italy
Ehime, 791-0280, Japan
Moscovskaya Oblast, Moscow Oblast 143423, Russia
Jeollanam-do, 58128, South Korea
A Coruña, LA Coruna 15006, Spain
Las Palmas de Gran Canaria, LAS Palmas 35016, Spain
Edirne, 22030, Turkey (Türkiye)
Metropolitan Borough of Wirral, L63 4JY, United Kingdom
Surrey, SM2 5PT, United Kingdom