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Brief Title: A Study of Setanaxib Co-Administered With Pembrolizumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
Official Title: A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Setanaxib, When Administered With Pembrolizumab, in Patients With Recurrent or Metastatic SCCHN
Study ID: NCT05323656
Brief Summary: The primary objective of this study is to compare the change in tumour size per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in recurrent or metastatic SCCHN patients treated with setanaxib and pembrolizumab versus patients treated with placebo and pembrolizumab.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
Siteman Cancer Center - West County, Creve Coeur, Missouri, United States
Siteman Cancer Center - North County, Florissant, Missouri, United States
Washington University School of Medicine Center for Advanced Medicine, Saint Louis, Missouri, United States
Siteman Cancer Center - St. Peters, Saint Peters, Missouri, United States
Institut de CancĂ©rologie de Lorraine, VandĆuvre-lĂšs-Nancy, Grand Est, France
Centre de Lutte contre le Cancer - Centre Oscar Lambret, Lille, Hauts-de-France, France
Centre Hospitalier Universitaire Amiens-Picardie - Site Sud, Amiens Cedex 1, Picardie, France
Ramsay Health Clinic Belharra, Bayonne, , France
HÎpital Saint-André, Bordeaux, , France
Centre LĂ©on BĂ©rard, Lyon, , France
HĂŽpital de la Timone, Marseille, , France
Institut RĂ©gional du Cancer de Montpellier, Montpellier, , France
Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany
Azienda Socio-Sanitaria Territoriale Santi Paolo e Carlo - Ospedale San Paolo Polo Universitario, Milano, Milan, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, , Italy
Centrum Onkologii Im. Prof. F. Ćukaszczyka w Bydgoszczy, Bydgoszcz, Kujawsko-pomorskie, Poland
Narodowy Instytut Onkologii im. Marii SkĆodowskiej-Curie-PaĆstwowy Instytut Badawczy O. w Gliwicach, Gliwice, Slaskie, Poland
Hospital ClĂnic de Barcelona, Barcelona, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Complejo Hospitalario de Navarra, Pamplona, , Spain
Hospital Universitario Virgen del RocĂo, Sevilla, , Spain
The Royal Marsden Hospital - London, London, England, United Kingdom
The Royal Marsden Hospital Head and Neck Unit, Sutton, England, United Kingdom