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Brief Title: Phase II Study of MEDI4736 Monotherapy in Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Official Title: A Phase II, Multi-Center, Single-Arm, Global Study of MEDI4736 Monotherapy in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study ID: NCT02207530
Brief Summary: Primary Objective: To assess the efficacy of MEDI4736 monotherapy in terms of ORR
Detailed Description: This is a phase II, multi-center, single-arm, global study of MEDI4736 monotherapy in patients with PD-L1 positive recurrent or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN), who have progressed during or after treatment with only 1 systemic palliative regimen for recurrent or metastatic disease that must have contained a platinum agent.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Birmingham, Alabama, United States
Research Site, Yuma, Arizona, United States
Research Site, Duarte, California, United States
Research Site, Fullerton, California, United States
Research Site, Long Beach, California, United States
Research Site, Los Angeles, California, United States
Research Site, Los Angeles, California, United States
Research Site, Los Angeles, California, United States
Research Site, San Francisco, California, United States
Research Site, Whittier, California, United States
Research Site, Denver, Colorado, United States
Research Site, Jacksonville, Florida, United States
Research Site, Augusta, Georgia, United States
Research Site, Macon, Georgia, United States
Research Site, Evanston, Illinois, United States
Research Site, Lexington, Kentucky, United States
Research Site, Baltimore, Maryland, United States
Research Site, Baltimore, Maryland, United States
Research Site, Boston, Massachusetts, United States
Research Site, Ann Arbor, Michigan, United States
Research Site, Southfield, Michigan, United States
Research Site, Minneapolis, Minnesota, United States
Research Site, Rochester, Minnesota, United States
Research Site, Saint Louis, Missouri, United States
Research Site, Lebanon, New Hampshire, United States
Research Site, Buffalo, New York, United States
Research Site, New York, New York, United States
Research Site, Stony Brook, New York, United States
Research Site, Durham, North Carolina, United States
Research Site, Winston-Salem, North Carolina, United States
Research Site, Portland, Oregon, United States
Research Site, Germantown, Tennessee, United States
Research Site, Nashville, Tennessee, United States
Research Site, Austin, Texas, United States
Research Site, Dallas, Texas, United States
Research Site, Fairfax, Virginia, United States
Research Site, Morgantown, West Virginia, United States
Research Site, Milwaukee, Wisconsin, United States
Research Site, Brussels, , Belgium
Research Site, Kortrijk, , Belgium
Research Site, Leuven, , Belgium
Research Site, Montigny-le-Tilleul, , Belgium
Research Site, Namur, , Belgium
Research Site, Calgary, Alberta, Canada
Research Site, London, Ontario, Canada
Research Site, Ottawa, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Zlin, , Czechia
Research Site, Angers, , France
Research Site, Bordeaux, , France
Research Site, Brest, , France
Research Site, Clermont Ferrand, , France
Research Site, Dijon, , France
Research Site, Le Mans, , France
Research Site, Lille cedex, , France
Research Site, Lorient cedex, , France
Research Site, Lyon Cedex 08, , France
Research Site, Montpellier Cedex 05, , France
Research Site, Nice, , France
Research Site, Plerin SUR MER, , France
Research Site, Rouen, , France
Research Site, St Grégoire, , France
Research Site, Strasbourg Cedex, , France
Research Site, Toulouse Cedex 9, , France
Research Site, Villejuif Cedex, , France
Research Site, Batumi, , Georgia
Research Site, Tbilisi, , Georgia
Research Site, Tbilisi, , Georgia
Research Site, Tbilisi, , Georgia
Research Site, Berlin, , Germany
Research Site, Halle, , Germany
Research Site, Heidelberg, , Germany
Research Site, Leipzig, , Germany
Research Site, München, , Germany
Research Site, Budapest, , Hungary
Research Site, Budapest, , Hungary
Research Site, Gyula, , Hungary
Research Site, Haifa, , Israel
Research Site, Petach-Tikva, , Israel
Research Site, Tel Hashomer, , Israel
Research Site, Daegu, , Korea, Republic of
Research Site, Goyang-si, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Suwon, , Korea, Republic of
Research Site, Kuala Lumpur, , Malaysia
Research Site, Kuching, , Malaysia
Research Site, Sabah, , Malaysia
Research Site, Barakaldo, , Spain
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Research Site, L'Hospitalet de Llobregat, , Spain
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Research Site, Madrid, , Spain
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Research Site, Malaga, , Spain
Research Site, Marbella (Málaga), , Spain
Research Site, Pamplona, , Spain
Research Site, Valencia, , Spain
Research Site, Valencia, , Spain
Research Site, Zaragoza, , Spain
Research Site, Taipei, , Taiwan
Research Site, Birmingham, , United Kingdom
Research Site, Glasgow, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Wirral, , United Kingdom
Name: Dan Paul Zandberg, MD
Affiliation: International Coordinating Investigator
Role: PRINCIPAL_INVESTIGATOR
Name: Magdalena Wrona
Affiliation: Medical Scientist AstraZeneca Magdalena.Wrona@astrazeneca.com
Role: STUDY_DIRECTOR