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Brief Title: Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
Official Title: A Randomized, Double-Blind, Multicenter, Phase 2 Study of Retifanlimab in Combination With INCAGN02385 (Anti-LAG-3) and INCAGN02390 (Anti-TIM-3) as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
Study ID: NCT05287113
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic Rochester, Scottsdale, Arizona, United States
City of Hope National Medical Center, Duarte, California, United States
City of Hope Orange County, Irvine, California, United States
University of California San Diego Medical Center, Moores Cancer Center, La Jolla, California, United States
City of Hope-Antelope Valley, Lancaster, California, United States
Innovative Clinical Research Institute, Long Beach, California, United States
City of Hope National Medical Center, Long Beach, California, United States
University of California San Francisco Comprehensive Cancer Center, San Francisco, California, United States
Georgetown University, Washington, District of Columbia, United States
Mayo Clinic Jacksonville, Jacksonville, Florida, United States
Blessed Health Care, Miami, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
University of Illinois At Chicago, Chicago, Illinois, United States
University of Iowa, Iowa City, Iowa, United States
University of Kansas Hospital Authority, Kansas City, Kansas, United States
University of Maryland-Greenebaum Cancer Center, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Cancer Center, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Hospital, Detroit, Michigan, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Huntsman Cancer Institute At University of Utah, Salt Lake City, Utah, United States
University of Virginia - Emily Couric Clinical Cancer Center, Charlottesville, Virginia, United States
Kadlec Clinic Hematology and Oncology, Kennewick, Washington, United States
Grand Hospital de Charleroi, Charleroi, , Belgium
Jessa Ziekenhuis, Hasselt, , Belgium
Gza Sint Augustinus, Wilrijk, , Belgium
McGill University Health Centre/Glen Site/Cedars Cancer Centre, Montreal, Quebec, Canada
Chum Hospital Notre Dame, Montreal, Quebec, Canada
McGill University Jewish General Hospital, Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Bordeaux, Bordeaux, , France
Institut Curie, Paris, , France
Centre Eugene Marquis, Rennes, , France
Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau, St Herblain, , France
Icans - Institut de Cancerologie Strasbourg Europe, Strasbourg, , France
Jsc Evex Hospitals, K'ut'aisi, , Georgia
New Hospitals, Tbilisi, , Georgia
Jsc Evex Corporation-Caraps Medline, Tbilisi, , Georgia
Ltd Cancer Research Centre, Tbilisi, , Georgia
University of Cologne, Cologne, , Germany
Universitatsklinikum Hamburg Eppendorf, Hamburg, , Germany
Asklepios Klinik Altona, Hamburg, , Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii, Mainz, , Germany
University Hospital of West Attica - Attikon, Chaidari, , Greece
Theagenio Anticancer Hospital, Thessaloniki, , Greece
Bioclinic Thessaloniki (Galinos Clinic), Thessaloniki, , Greece
Saint Lukas Clinic, Thessaloniki, , Greece
Fondazione Del Piemonte Per L Oncologia Ircc Candiolo, Candiolo, , Italy
European Institute of Oncology, Milano, , Italy
Fondazione Irccs Istituto Nazionale Del Tumori Di Milano, Milan, , Italy
Istituto Nazionale Tumori Irccs Fondazione Pascale, Naples, , Italy
Iov - Istituto Oncologico Veneto Irccs, Padova, , Italy
Fondazione Irccs Policlinico San Matteo, Pavia, , Italy
Ausl-Irccs Di Reggio Emilia, Reggio Emilia, , Italy
Pusan National University Yangsan Hospital, Busan, , Korea, Republic of
Chonnam National University Hwasun Hospital, Gwangju, , Korea, Republic of
Cha Bundang Medical Center, Seongnam-si, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Kangbuk Samsung Hospital, Seoul, , Korea, Republic of
Kunkuk University Medical Center, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Pusan National University Yangsan Hospital, Yangsan, , Korea, Republic of
The Dutch Cancer Institue, Amsterdam, , Netherlands
Leids Universitair Medisch Centrum (Lumc) (Leiden University Medical Center), Leiden, , Netherlands
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka, Bydgoszcz, , Poland
Przychodnia Lekarska Komed Roman Karaszewski, Konin, , Poland
Centrum Onkologii Ziemi Lubelskiej Im. SW. Jana Z Dukli, Lublin, , Poland
Poznan University of Medical Sciences, Poznan, , Poland
Nzoz Provita Prolife Centrum Medyczne, Tomaszow Mazowiecki, , Poland
Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie, Warszawa, , Poland
Hospital de Braga, Braga, , Portugal
Centro Hospitalar Universitario Algarve, Faro, , Portugal
Centro Hospitalar de Lisboa Norte E.P.E. - Hospital de Santa Maria, Lisboa, , Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E., Porto, , Portugal
Centro Hospitalar de Sao Joao Alameda, Porto, , Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho, Epe-Unidade L, Vila Nova de Gaia, , Portugal
Catalans Institute of Oncology Barcelona, Barcelona, , Spain
Ico Girona Hospital Universitari de Girona Dr Josep Trueta, Girona, , Spain
Fundacion Jimenez Diaz University Hospital, Madrid, , Spain
Hospital Universitario Ramon Y Cajal, Madrid, , Spain
Hospital Universitario Quironsalud Madrid, Madrid, , Spain
Hospital Regional Universitario Carlos Haya, Malaga, , Spain
Complejo Hospitalario de Navarra, Pamplona, , Spain
Hospital Universitario Marques de Valdecilla, Santander, , Spain
Hospital General Universitario de Valencia, Valencia, , Spain
Hospital Universitari I Politecnic La Fe, Valencia, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, , Taiwan
Chang Gung Medical Foundation. Kaohsiung Branch, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung City, , Taiwan
Institutional Review Board Taipei Veterans General Hospital, Taipei, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan