Spots Global Cancer Trial Database for Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer
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Trial Identification
Brief Title: Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in 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
Study ID: NCT04590963
Study Description
Brief 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.
Detailed Description: Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who had prior immune checkpoint inhibitor and platinum-based chemotherapy treatment will be randomized in a 2:1 ratio to monalizumab and cetuximab or placebo and cetuximab. Efficacy and safety assessments will be performed periodically from the time of enrollment and throughout the study. Participants in all arms will continue therapy until progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. All Participants will be followed for survival after progression is confirmed.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Tucson, Arizona, United States
Research Site, Chicago, Illinois, United States
Research Site, Westwood, Kansas, United States
Research Site, Boston, Massachusetts, United States
Research Site, Ann Arbor, Michigan, United States
Research Site, Rochester, Minnesota, United States
Research Site, Saint Louis, Missouri, United States
Research Site, Las Vegas, Nevada, United States
Research Site, New York, New York, United States
Research Site, Charlotte, North Carolina, United States
Research Site, Winston-Salem, North Carolina, United States
Research Site, Columbus, Ohio, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Dallas, Texas, United States
Research Site, Houston, Texas, United States
Research Site, Caba, , Argentina
Research Site, Caba, , Argentina
Research Site, Caba, , Argentina
Research Site, Camperdown, , Australia
Research Site, Elizabeth Vale, , Australia
Research Site, Heidelberg, , Australia
Research Site, Melbourne, , Australia
Research Site, Linz, , Austria
Research Site, Bruxelles, , Belgium
Research Site, Leuven, , Belgium
Research Site, Namur, , Belgium
Research Site, Roeselare, , Belgium
Research Site, Belo Horizonte, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Rio de Janeiro, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, Panagyurishte, , Bulgaria
Research Site, Plovdiv, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Victoria, British Columbia, Canada
Research Site, Hamilton, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Avignon, , France
Research Site, Bordeaux, , France
Research Site, Clermont Ferrand cedex 01, , France
Research Site, Dijon, , France
Research Site, Lyon Cedex 08, , France
Research Site, Marseille, , France
Research Site, Montpellier Cedex 05, , France
Research Site, Strasbourg, , France
Research Site, Berlin, , Germany
Research Site, Essen, , Germany
Research Site, Freiburg, , Germany
Research Site, Hannover, , Germany
Research Site, Leipzig, , Germany
Research Site, Ulm, , Germany
Research Site, Würzburg, , Germany
Research Site, Athens, , Greece
Research Site, Chaidari, , Greece
Research Site, Thessaloniki, , Greece
Research Site, Brescia, , Italy
Research Site, Candiolo, , Italy
Research Site, Firenze, , Italy
Research Site, Milano, , Italy
Research Site, Milano, , Italy
Research Site, Modena, , Italy
Research Site, Napoli, , Italy
Research Site, Padova, , Italy
Research Site, Chuo-ku, , Japan
Research Site, Fukuoka-shi, , Japan
Research Site, Hiroshima-shi, , Japan
Research Site, Isehara-shi, , Japan
Research Site, Kashiwa, , Japan
Research Site, Kobe-shi, , Japan
Research Site, Koto-ku, , Japan
Research Site, Okayama, , Japan
Research Site, Osakasayama, , Japan
Research Site, Sunto-gun, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Busan, , Korea, Republic of
Research Site, Cheongju-si, , Korea, Republic of
Research Site, Goyang-si, , 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, Amsterdam, , Netherlands
Research Site, Maastricht, , Netherlands
Research Site, Nijmegen, , Netherlands
Research Site, Manila, , Philippines
Research Site, Pasig City, , Philippines
Research Site, Quezon City, , Philippines
Research Site, Białystok, , Poland
Research Site, Bydgoszcz, , Poland
Research Site, Poznan, , Poland
Research Site, Coimbra, , Portugal
Research Site, Porto, , Portugal
Research Site, Porto, , Portugal
Research Site, Vila Nova de Gaia, , Portugal
Research Site, Moscow region, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Obninsk, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Saint-Petersburg, , Russian Federation
Research Site, Saint-Petersburg, , Russian Federation
Research Site, St.Petersburg, , Russian Federation
Research Site, Barcelona, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Valencia, , Spain
Research Site, Basel, , Switzerland
Research Site, Bern, , Switzerland
Research Site, Lausanne, , Switzerland
Research Site, Changhua, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Tainan City, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, London, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Newcastle upon Tyne, , United Kingdom
Research Site, Sutton, , United Kingdom
Contact Details
Name: Roger B Cohen, MD
Affiliation: Abramson Cancer Center, Perelman Center for Advanced Medicine
Role: PRINCIPAL_INVESTIGATOR
Name: Jérôme Fayette, MD
Affiliation: Centre Leon Berard
Role: PRINCIPAL_INVESTIGATOR
Name: Dario Ruscica, MD
Affiliation: AstraZeneca, Cambridge, UK
Role: STUDY_DIRECTOR
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