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



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:February 28, 2019
End Date:December 28, 2028
Contact:Reference Study ID Number: BO40729 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 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.


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)
We found this trial at
28
sites
Nashville, Tennessee 37203
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, MI
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Aurora, Colorado 80045
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Aurora, CO
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401 North Broadway
Baltimore, Maryland 21287
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Baltimore, MD
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Birmingham, AL
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Bruxelles,
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Charlotte, NC
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Chicago, IL
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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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Cincinnati, OH
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Duarte, California 91010
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Duarte, CA
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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9801 Kincey Avenue
Huntersville, North Carolina 28078
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Huntersville, NC
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4018 West Capitol Avenue
Little Rock, Arkansas 72205
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Little Rock, AR
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Los Angeles, California 90095
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Los Angeles, CA
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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New Haven, Connecticut 06520
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New Haven, CT
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New Haven, CT
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1275 York Avenue
New York, New York 10065
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New York, NY
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550 1st Ave
New York, New York 10016
(212) 263-7300
New York University School of Medicine NYU School of Medicine has a proud history that...
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New York, NY
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Philadelphia, Pennsylvania 19111
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Philadelphia, PA
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San Antonio, TX
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10460 North 92nd Street
Scottsdale, Arizona 85258
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Scottsdale, AZ
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Stanford, CA
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5520 Park Avenue
Trumbull, Connecticut 06611
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Trumbull, CT
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Washington, District of Columbia 20057
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Washington,
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