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



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:3/28/2019
Start Date:September 20, 2017
End Date:August 5, 2027
Contact:Reference Study ID Number: BO39633 www.roche.com/about_roche/ roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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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 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:

- 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

- 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 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 parent study and in survival follow up
at the time of parent study closure, or eligible for continuing or crossing over to
atezolizumab-based therapy as per the parent protocol and have access to commercially
available atezolizumab (Tecentriq) outside this extension study at the time of the
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
We found this trial at
48
sites
Vallejo, California 94589
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1045 North 30th Street
Billings, Montana 59101
406-255-8470
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
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Albany, New York 12206
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Aurora, Colorado 80045
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Baltimore, Maryland 21205
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450 Brookline Avenue
Boston, Massachusetts 02115
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Carrollton, Georgia 30117
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303 East Superior Street
Chicago, Illinois 60611
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Commack, New York 11725
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1800 North Williams Street
Denver, Colorado 80218
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Detroit, Michigan 48201
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Eugene, Oregon 97401
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140 Park Avenue
Florham Park, New Jersey 07932
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4371 Veronica S Shoemaker Boulevard
Fort Myers, Florida 33916
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Fort Worth, Texas 76177
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Greenville, South Carolina 29605
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Hershey, Pennsylvania 17033
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9801 Kincey Avenue
Huntersville, North Carolina 28078
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Knoxville, Tennessee 37920
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3730 South Eastern Avenue
Las Vegas, Nevada 89169
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11818 Wilshire Boulevard
Los Angeles, California 90025
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Los Angeles, California 90095
(310) 825-4321
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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910 East 26th Street
Minneapolis, Minnesota 55404
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3322 West End Avenue
Nashville, Tennessee 37203
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New Haven, Connecticut 06520
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5900 Lake Wright Drive
Norfolk, Virginia 23502
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5050 Northeast Hoyt Street
Portland, Oregon 97227
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Reno, NV
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Roanoke, Virginia 24014
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Petersburg, Florida 33705
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San Marcos, California 92078
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Scarborough, Maine 04074
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Scottsdale, Arizona 85258
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Washington, District of Columbia 20057
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