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Brief Title: Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer
Official Title: A Phase III Randomized, Open-label, Multi-center, Global Study of MEDI4736 Alone or in Combination With Tremelimumab Versus Standard of Care in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer Patients
Study ID: NCT02551159
Brief Summary: This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease.
Detailed Description: Patients will be randomized in a 2:1:1 ratio to MEDI4736 + tremelimumab combination therapy, MEDI4736 monotherapy, or SoC. Patients in all arms will continue therapy until progression. Tumor assessments will be performed on computed tomography scans or magnetic resonance imaging scans, preferably with intravenous (IV) contrast. Efficacy for all patients will be assessed by objective tumor assessments every 6 weeks for the first 24 weeks, then every 8 weeks thereafter until treatment discontinuation due to progression or toxicity. All patients will be followed every 3 months for survival after progression is confirmed.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Aurora, Colorado, United States
Research Site, Washington, District of Columbia, United States
Research Site, Fort Myers, Florida, United States
Research Site, Saint Petersburg, Florida, United States
Research Site, Tampa, Florida, United States
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Research Site, Graz, , Austria
Research Site, Innsbruck, , Austria
Research Site, Linz, , Austria
Research Site, Wien, , Austria
Research Site, Brussels, , Belgium
Research Site, Brussels, , Belgium
Research Site, Bruxelles, , Belgium
Research Site, Leuven, , Belgium
Research Site, Namur, , Belgium
Research Site, Barretos, , Brazil
Research Site, Curitiba, , Brazil
Research Site, Florianópolis, , Brazil
Research Site, Ijui, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Recife, , Brazil
Research Site, Rio de Janeiro, , Brazil
Research Site, Santo Andre, , Brazil
Research Site, Santo André, , Brazil
Research Site, São José do Rio Preto, , Brazil
Research Site, São Paulo, , Brazil
Research Site, Calgary, Alberta, Canada
Research Site, Winnipeg, Manitoba, Canada
Research Site, Moncton, New Brunswick, Canada
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Research Site, Bordeaux, , France
Research Site, Brest, , France
Research Site, Dijon, , France
Research Site, Lyon Cedex 08, , France
Research Site, Nice, , France
Research Site, Paris, , France
Research Site, Poitiers Cedex, , France
Research Site, Toulouse Cedex, , France
Research Site, Vandoeuvre les Nancy, , France
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Research Site, Berlin, , Germany
Research Site, Erlangen, , Germany
Research Site, Essen, , Germany
Research Site, Frankfurt am Main, , Germany
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Research Site, Heidelberg, , Germany
Research Site, Mainz, , Germany
Research Site, Tübingen, , Germany
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Research Site, Athens, , Greece
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Research Site, Heraklion, , Greece
Research Site, Thessaloniki, , Greece
Research Site, Bangalore, , India
Research Site, Bangalore, , India
Research Site, Bengaluru, , India
Research Site, Gurgaon, , India
Research Site, Karamsad, , India
Research Site, Madurai, , India
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Research Site, Cona, , Italy
Research Site, Firenze, , Italy
Research Site, Messina, , Italy
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Research Site, Cheongju-si, , Korea, Republic of
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Research Site, Incheon, , Korea, Republic of
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Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
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Research Site, Cebu City, , Philippines
Research Site, Las Pinas, , Philippines
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Research Site, Białystok, , Poland
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Research Site, Suceava, , Romania
Research Site, Arkhangelsk, , Russian Federation
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Research Site, Saint Petersburg, , Russian Federation
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Research Site, Saint-Petersburg, , Russian Federation
Research Site, Sochi, , Russian Federation
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Research Site, Ufa, , Russian Federation
Research Site, Bratislava, , Slovakia
Research Site, Kosice, , Slovakia
Research Site, Badajoz, , Spain
Research Site, Barcelona, , Spain
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Research Site, Jaén, , Spain
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Research Site, Marbella, , Spain
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Research Site, Kaohsiung, , Taiwan
Research Site, Taichung, , Taiwan
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Research Site, Dnipro, , Ukraine
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Research Site, Hanoi, , Vietnam
Research Site, Ho Chi Minh city, , Vietnam
Name: Richard Olsson
Affiliation:
Role: STUDY_DIRECTOR
Name: Tanguy Seiwert
Affiliation: The University of Chicago, 5841 S Maryland Ave, Chicago, IL 60637
Role: PRINCIPAL_INVESTIGATOR