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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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