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
NCT ID: NCT05287113
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
176 participants
INTERVENTIONAL
2022-11-14
2026-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment Group 1: Retifanlimab Monotherapy
Retifanlimab will be administered intravenously every 4 weeks. Placebos for INCAGN02385 and INCAGN02390 will be administered intravenously every 2 weeks.
Retifanlimab
Retifanlimab 500mg will be administered intravenously every 4 weeks.
Placebo
Placebo will be administered intravenously.
Treatment Group 2: Retifanlimab + INCAGN02385
Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and Placebo for INCAGN02390 will be administered intravenously every 2 weeks.
Retifanlimab
Retifanlimab 500mg will be administered intravenously every 4 weeks.
INCAGN02385
INCAGN02385 350mg will be administered intravenously every 2 weeks.
Placebo
Placebo will be administered intravenously.
Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390
Retifanlimab plus INCAGN02385 and INCAGN02390 will be administered intravenously. Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and INCAGN02390 will be administered every 2 weeks.
Retifanlimab
Retifanlimab 500mg will be administered intravenously every 4 weeks.
INCAGN02385
INCAGN02385 350mg will be administered intravenously every 2 weeks.
INCAGN02390
INCAGN02390 400 mg will be administered intravenously every 2 weeks.
Interventions
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Retifanlimab
Retifanlimab 500mg will be administered intravenously every 4 weeks.
INCAGN02385
INCAGN02385 350mg will be administered intravenously every 2 weeks.
INCAGN02390
INCAGN02390 400 mg will be administered intravenously every 2 weeks.
Placebo
Placebo will be administered intravenously.
Eligibility Criteria
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Inclusion Criteria
* Eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
* Participants must not have received prior systemic therapy for R/M SCCHN.
* PD-L1 positive tumor status defined by CPS ≥ 1% per central laboratory determination.
* For participants with primary oropharyngeal tumors, documentation of HPV p16 status based on local institutional standard is required. HPV p16 status is not required for other eligible SCCHN primary tumor sites.
* Participant must have at least 1 measurable tumor lesion per RECIST v1.1.
* Availability of archival tissue for biomarker analysis from a core or excisional biopsy or willingness to undergo a fresh biopsy.
* ECOG performance status of 0 or 1.
* Willingness to avoid pregnancy or fathering children.
Exclusion Criteria
* Treatment with anticancer therapies or participation in another interventional clinical study within 21 days before the first administration of study treatment.
* Presence of tumors that invade major blood vessels, as shown unequivocally by imaging, and with active bleeding.
* Participants with primary tumors of the nasopharynx, sinonasal cavity, or salivary and are excluded.
* Less than 3-month life expectancy.
* Participant has not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy.
* Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study treatment.
* Palliative radiation therapy administered within 1 week before the first dose of study treatment or radiation therapy in the thoracic region that is \> 30 Gy within 6 months before the first dose of study treatment.
* Known active CNS metastases and/or carcinomatous meningitis. Participants will be excluded if it has been \< 4 weeks since radiation therapy was delivered to the CNS.
18 Years
99 Years
ALL
No
Sponsors
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Incyte Biosciences International Sàrl
INDUSTRY
Responsible Party
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Locations
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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
Padua, , 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
Countries
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Related Links
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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
Other Identifiers
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2023-504270-38-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-005775-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCAGN 2385-203
Identifier Type: -
Identifier Source: org_study_id
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