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ACTIVE NOT RECRUITING
NCT05287113
PHASE2

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

Sponsor: Incyte Biosciences International Sàrl

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

176

Start Date

2022-11-14

Completion Date

2026-07-10

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

DRUG

Retifanlimab

Retifanlimab 500mg will be administered intravenously every 4 weeks.

DRUG

INCAGN02385

INCAGN02385 350mg will be administered intravenously every 2 weeks.

DRUG

INCAGN02390

INCAGN02390 400 mg will be administered intravenously every 2 weeks.

DRUG

Placebo

Placebo will be administered intravenously.

Locations (91)

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 D.C., 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

Saint-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

Chaïdári, 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

Fondazione Irccs Istituto Nazionale Del Tumori Di Milano

Milan, Italy

European Institute of Oncology

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

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

Tomaszów Mazowiecki, Poland

Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie

Warsaw, Poland

Hospital de Braga

Braga, Portugal

Centro Hospitalar Universitario Algarve

Faro, Portugal

Centro Hospitalar de Lisboa Norte E.P.E. - Hospital de Santa Maria

Lisbon, 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

Pusan National University Yangsan Hospital

Busan, South Korea

Chonnam National University Hwasun Hospital

Gwangju, South Korea

Cha Bundang Medical Center

Seongnam-si, South Korea

Korea University Anam Hospital

Seoul, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

Kunkuk University Medical Center

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Pusan National University Yangsan Hospital

Yangsan, South Korea

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

Málaga, 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 City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Institutional Review Board Taipei Veterans General Hospital

Taipei, Taiwan

National Taiwan University Hospital

Taipei, Taiwan