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Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer
Sponsor: AstraZeneca
Summary
This is a randomized, double-blind, multicenter, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in Participants with recurrent or metastatic head and neck cancer
Official title: A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Participants With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
370
Start Date
2020-10-02
Completion Date
2026-09-24
Last Updated
2026-03-13
Healthy Volunteers
No
Interventions
Monalizumab
Participants will receive IV infusion of monalizumab as stated in arm description.
Cetuximab
Participants will receive IV infusion of cetuximab as stated in arm description.
Placebo
Participants will receive IV infusion of placebo as stated in arm description.
Locations (127)
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Tucson, Arizona, United States
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Chicago, Illinois, United States
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Westwood, Kansas, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Columbus, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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CABA, Argentina
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CABA, Argentina
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CABA, Argentina
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Camperdown, Australia
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Elizabeth Vale, Australia
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Heidelberg, Australia
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Melbourne, Australia
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Linz, Austria
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Brussels, Belgium
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Leuven, Belgium
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Namur, Belgium
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Roeselare, Belgium
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Belo Horizonte, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Panagyurishte, Bulgaria
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Victoria, British Columbia, Canada
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Hamilton, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Avignon, France
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Bordeaux, France
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Clermont-Ferrand, France
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Dijon, France
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Lyon, France
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Marseille, France
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Montpellier, France
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Strasbourg, France
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Berlin, Germany
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Essen, Germany
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Freiburg im Breisgau, Germany
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Hanover, Germany
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Leipzig, Germany
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Ulm, Germany
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Würzburg, Germany
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Athens, Greece
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Chaïdári, Greece
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Thessaloniki, Greece
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Brescia, Italy
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Candiolo, Italy
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Florence, Italy
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Milan, Italy
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Milan, Italy
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Modena, Italy
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Naples, Italy
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Padova, Italy
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Chūōku, Japan
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Fukuoka, Japan
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Hiroshima, Japan
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Isehara-shi, Japan
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Kashiwa, Japan
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Kobe, Japan
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Kōtoku, Japan
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Okayama, Japan
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Sayama, Japan
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Sunto-gun, Japan
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Yokohama, Japan
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Yokohama, Japan
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Amsterdam, Netherlands
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Maastricht, Netherlands
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Nijmegen, Netherlands
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Manila, Philippines
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Pasig, Philippines
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Quezon City, Philippines
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Bialystok, Poland
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Bydgoszcz, Poland
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Poznan, Poland
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Coimbra, Portugal
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Porto, Portugal
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Porto, Portugal
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Vila Nova de Gaia, Portugal
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Moscow, Russia
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Moscow Region, Russia
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Obninsk, Russia
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Saint Petersburg, Russia
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Saint Petersburg, Russia
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Saint Petersburg, Russia
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Saint Petersburg, Russia
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Busan, South Korea
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Cheongju-si, South Korea
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Goyang-si, South Korea
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Seongnam-si, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Barcelona, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Valencia, Spain
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Basel, Switzerland
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Bern, Switzerland
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Lausanne, Switzerland
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Changhua, Taiwan
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Taichung, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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London, United Kingdom
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Manchester, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Sutton, United Kingdom