Atezolizumab: Atezolizumab 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, or switch to a fixed atezolizumab dose of 1200 mg every 3 weeks (Q3W).
Bevacizumab: Bevacizumab will be administered as directed per the parent study.
Study summary
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.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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):
* Eligible for continuing or crossing over to atezolizumab-based therapy at the time of the parent-study closure as per the parent study or eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study at the time of the parent-study closure as per the parent study, with no access to commercially available comparator agent
* First dose of study treatment in the 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 parent-study closure as assessed by the investigator
* Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential
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:
* Meet of 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 (± 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 SAE(s) that has not resolved to baseline level or Grade less than or equal to (\<=) 1 from 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
* 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 participant at high risk for treatment-related complications
* Concurrent participation in any therapeutic clinical trial (other than the parent 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
Primary outcome measure(s)
Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s) — Day 1 up to maximum 10 years
Trial sites (170)
Facility
City
Region
Status
HonorHealth Research Institute ? Bisgrove
Scottsdale
Arizona
Angeles Clinic & Rsch Inst
Los Angeles
California
UCLA
Los Angeles
California
Kaiser Permanente - San Diego (Zion Ave)
San Marcos
California
University Of Colorado
Aurora
Colorado
Rocky Mountain Cancer Ctr - Denver (Williams)
Denver
Colorado
Smilow Cancer Hospital at Yale New Haven
New Haven
Connecticut
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C.
District of Columbia
Florida Cancer Specialists - Fort Myers (Broadway)
Fort Myers
Florida
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie
Florida
Florida Cancer Specialists.
St. Petersburg
Florida
H. Lee Moffitt Cancer Center and Research Inst.
Tampa
Florida
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta
Georgia
Northwestern University
Chicago
Illinois
Rush University Medical Center
Chicago
Illinois
University Of Chicago Medical Center
Chicago
Illinois
Ingalls Memorial Hospital
Harvey
Illinois
Illinois Cancer Care
Peoria
Illinois
New England Cancer Specialists
Westbrook
Maine
Johns Hopkins Univ Med Center
Baltimore
Maryland
Maryland Oncology Hematology, P.A.
Columbia
Maryland
Massachusetts General Hospital.
Boston
Massachusetts
Beth Israel Medical Center
Boston
Massachusetts
Dana Farber Cancer Inst.
Boston
Massachusetts
Karmanos Cancer Institute
Detroit
Michigan
US oncology research at Minnesota Oncology
Saint Louis Park
Minnesota
Washington University School of Medicine
St Louis
Missouri
Comprehensive Cancer Centers of Nevada - Eastern Avenue
Las Vegas
Nevada
Summit Medical Center
Florham Park
New Jersey
New York Oncology Hematology, P.C.
Albany
New York
Memorial Sloan-Kettering Cancer Center
New York
New York
Carolina BioOncology Institute, PLCC
Huntersville
North Carolina
Cleveland Clinic
Cleveland
Ohio
Oncology Associates of Oregon, P.C
Eugene
Oregon
Northwest Cancer Specialists - Portland (N Broadway)
Portland
Oregon
Penn State Hershey Cancer Institute
Hershey
Pennsylvania
Allegheny Cancer Center
Pittsburgh
Pennsylvania
Sarah Cannon Res Inst
Nashville
Tennessee
Texas Oncology - DFW
Dallas
Texas
Tyler Cancer Center
Tyler
Texas
+ 130 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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