A Study of Atezolizumab (Anti−Pd-L1 Antibody) as Adjuvant Therapy After Definitive Local Therapy in Patients With High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/28/2019
Start Date:April 3, 2018
End Date:April 28, 2025
Contact:Reference Study ID Number: WO40242 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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A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti−Pd-L1 Antibody) as Adjuvant Therapy After Definitive Local Therapy in Patients With High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck

This study will evaluate the efficacy and safety of atezolizumab compared with placebo as
adjuvant therapy after definitive local therapy in patients with high-risk locally advanced
squamous cell carcinoma of the head and neck (SCCHN)


Inclusion Criteria

- Histologically or cytologically confirmed Squamous Cell Carcinoma of the Head and Neck
(SCCHN)

- Human Papilloma Virus (HPV) status

- Completed definitive local therapy

- Absence of metastatic disease as documented by radiographic scans

- Adequate hematologic and end-organ function

- For patients receiving therapeutic anticoagulation: stable anticoagulant regimen

- For women of childbearing potential: agreement to remain abstinent or use
contraceptive methods with a failure rate of < 1% per year during the treatment period
and for 5 months after the last dose of study treatment. Women must refrain from
donating eggs during this same period.

- Confirmed response of Complete Response (CR), Partial Response (PR), or Stable Disease
(SD) to definitive local therapy documented by CT with contrast or MRI with contract
to head and neck region done >= 8 weeks after completion of definitive local therapy
and within 28 days prior to initiation of study drug.

Exclusion Criteria:

- Patients who have received surgery alone or radiotherapy alone as definitive local
therapy

- Squamous cell carcinoma of the nasopharynx or paranasal sinuses or non-squamous
histology

- Evidence of disease progression or metastatic disease during or following definitive
local therapy documented in post-definitive local therapy screening scans

- Uncontrolled or symptomatic hypercalcemia

- Active or history of autoimmune disease or immune deficiency

- Active tuberculosis

- Significant cardiovascular disease

- History of malignancy, including prior SCCHN primary tumors within 5 years prior to
screening, with the exception of malignancies with a negligible risk of metastasis or
death

- Prior allogeneic stem cell or solid organ transplantation

- Current treatment with anti-viral therapy for Hepatitis B Virus (HBV)

- Treatment with systemic immunostimulatory agents

- Treatment with systemic immunosuppressive medication

- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies
or fusion proteins

- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment
or within 5 months after the last dose of study treatment

- Patients who have received a non-FDA or non-EMA approved anti-EGFR agent or any other
non-FDA or non-EMA, approved agent as part of definitive local therapy, unless the
unapproved agent was given in addition to an approved agent

- Any systemic therapies after permitted definitive local therapies
We found this trial at
30
sites
1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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1045 North 30th Street
Billings, Montana 59101
406-255-8470
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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1700 North Wheeling Street
Aurora, Colorado 80045
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Bellflower, California 90706
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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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10710 Charter Drive
Columbia, Maryland 21044
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Columbus, Ohio 43210
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Daphne, Alabama 36526
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Detroit, Michigan 48202
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Kogarah, New South Wales 2217
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3855 Health Sciences Drive
La Jolla, California 92093
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Los Angeles, California 90033
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Marietta, Georgia 30060
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8900 North Kendall Drive
Miami, Florida 33176
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Morristown, NJ
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Pensacola, Florida 32503
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Peoria, Illinois 61656
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333 Cottman Avenue
Philadelphia, Pennsylvania 19111
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Roanoke, Virginia 24014
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Santa Monica, California 90404
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Tucson, Arizona 85721
(520) 621-2211
University of Arizona The University of Arizona is a premier, public research university. Established in...
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Vallejo, California 94589
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Vancouver, Washington 98684
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5255 Loughboro Road Northwest
Washington, District of Columbia 20016
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3970 Reservoir Road Northwest
Washington, District of Columbia 20016
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818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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