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Spots Global Cancer Trial Database for Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Research Site, Atlanta, Georgia, United States

Research Site, Chicago, Illinois, United States

Research Site, Baltimore, Maryland, United States

Research Site, Baltimore, Maryland, United States

Research Site, Boston, Massachusetts, United States

Research Site, Morristown, New Jersey, United States

Research Site, New York, New York, United States

Research Site, New York, New York, United States

Research Site, Chapel Hill, North Carolina, United States

Research Site, Charlotte, North Carolina, United States

Research Site, Winston-Salem, North Carolina, United States

Research Site, Cleveland, Ohio, United States

Research Site, Columbus, Ohio, United States

Research Site, Nashville, Tennessee, United States

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

Research Site, Halifax, Nova Scotia, Canada

Research Site, Hamilton, Ontario, Canada

Research Site, London, Ontario, Canada

Research Site, Ottawa, Ontario, Canada

Research Site, Toronto, Ontario, Canada

Research Site, Montreal, Quebec, Canada

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

Research Site, Villejuif, , France

Research Site, Berlin, , Germany

Research Site, Erlangen, , Germany

Research Site, Essen, , Germany

Research Site, Frankfurt am Main, , Germany

Research Site, Freiburg, , Germany

Research Site, Hamburg, , Germany

Research Site, Heidelberg, , Germany

Research Site, Mainz, , Germany

Research Site, Tübingen, , Germany

Research Site, Würzburg, , Germany

Research Site, Athens, , Greece

Research Site, Athens, , Greece

Research Site, Athens, , Greece

Research Site, Athens, , Greece

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

Research Site, Pune, , India

Research Site, Cona, , Italy

Research Site, Firenze, , Italy

Research Site, Messina, , Italy

Research Site, Milano, , Italy

Research Site, Padova, , Italy

Research Site, Palermo, , Italy

Research Site, Salerno, , Italy

Research Site, Siena, , Italy

Research Site, Torino, , Italy

Research Site, Akashi-shi, , Japan

Research Site, Chiba-shi, , Japan

Research Site, Fukuoka-shi, , Japan

Research Site, Hirakata-shi, , Japan

Research Site, Isehara-shi, , Japan

Research Site, Kagoshima-shi, , Japan

Research Site, Kanazawa-shi, , Japan

Research Site, Kitaadachi-gun, , Japan

Research Site, Kobe-shi, , Japan

Research Site, Koto-ku, , Japan

Research Site, Natori-shi, , Japan

Research Site, Okayama-shi, , Japan

Research Site, Osaka-shi, , Japan

Research Site, Osakasayama, , Japan

Research Site, Sapporo-shi, , Japan

Research Site, Sapporo, , Japan

Research Site, Sunto-gun, , Japan

Research Site, Takatsuki-shi, , Japan

Research Site, Toyoake-shi, , Japan

Research Site, Yokohama-shi, , Japan

Research Site, Cheongju-si, , Korea, Republic of

Research Site, Hwasun-gun, , Korea, Republic of

Research Site, Incheon, , Korea, Republic of

Research Site, Seo-Gu, , Korea, Republic of

Research Site, Seongnam-si, , Korea, Republic of

Research Site, Seoul, , Korea, Republic of

Research Site, Seoul, , Korea, Republic of

Research Site, Seoul, , Korea, Republic of

Research Site, Seoul, , Korea, Republic of

Research Site, Suwon-si, , Korea, Republic of

Research Site, Cebu City, , Philippines

Research Site, Las Pinas, , Philippines

Research Site, Quezon City, , Philippines

Research Site, Białystok, , Poland

Research Site, Bielsko-Biała, , Poland

Research Site, Gdańsk, , Poland

Research Site, Gdynia, , Poland

Research Site, Lublin, , Poland

Research Site, Poznan, , Poland

Research Site, Poznan, , Poland

Research Site, Szczecin, , Poland

Research Site, Warszawa, , Poland

Research Site, Łódź, , Poland

Research Site, Suceava, , Romania

Research Site, Arkhangelsk, , Russian Federation

Research Site, Ekaterinburg, , Russian Federation

Research Site, Krasnodar, , Russian Federation

Research Site, Moscow, , Russian Federation

Research Site, Obninsk, , Russian Federation

Research Site, Omsk, , Russian Federation

Research Site, Saint Petersburg, , Russian Federation

Research Site, Saint Petersburg, , Russian Federation

Research Site, Saint-Petersburg, , Russian Federation

Research Site, Sochi, , Russian Federation

Research Site, St.Petersburg, , Russian Federation

Research Site, Ufa, , Russian Federation

Research Site, Bratislava, , Slovakia

Research Site, Kosice, , Slovakia

Research Site, Badajoz, , Spain

Research Site, Barcelona, , Spain

Research Site, Barcelona, , Spain

Research Site, Jaén, , Spain

Research Site, L'Hospitalet de Llobregat, , Spain

Research Site, Madrid, , Spain

Research Site, Madrid, , Spain

Research Site, Madrid, , Spain

Research Site, Madrid, , Spain

Research Site, Marbella, , Spain

Research Site, Málaga, , Spain

Research Site, Valencia, , Spain

Research Site, Zaragoza, , Spain

Research Site, Kaohsiung, , Taiwan

Research Site, Taichung, , Taiwan

Research Site, Taichung, , Taiwan

Research Site, Tainan, , Taiwan

Research Site, Taipei, , Taiwan

Research Site, Taipei, , Taiwan

Research Site, Taipei, , Taiwan

Research Site, Bangkok, , Thailand

Research Site, Bangkok, , Thailand

Research Site, Chiang Mai, , Thailand

Research Site, Hat Yai, , Thailand

Research Site, Pathumthani, , Thailand

Research Site, Dnipro, , Ukraine

Research Site, Ivano-Frankivsk, , Ukraine

Research Site, Kapitanivka Village, , Ukraine

Research Site, Kharkiv Region, , Ukraine

Research Site, Kirovohrad, , Ukraine

Research Site, Kryvyi Rih, , Ukraine

Research Site, Kyiv, , Ukraine

Research Site, Kyiv, , Ukraine

Research Site, Odesa, , Ukraine

Research Site, Sumy, , Ukraine

Research Site, Vinnytsia, , Ukraine

Research Site, Bebington, , United Kingdom

Research Site, Birmingham, , United Kingdom

Research Site, London, , United Kingdom

Research Site, London, , United Kingdom

Research Site, Manchester, , United Kingdom

Research Site, Sutton, , United Kingdom

Research Site, Taunton, , United Kingdom

Research Site, Ha Noi, , Vietnam

Research Site, Hanoi, , Vietnam

Research Site, Hanoi, , Vietnam

Research Site, Ho Chi Minh city, , Vietnam

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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