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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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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