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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

176

Participants

Timeline

Start Date

November 14, 2022

Primary Completion Date

March 14, 2025

Study Completion Date

July 10, 2026

Conditions
Head and Neck Cancer
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.

Trial Locations (91)

10002

National Taiwan University Hospital, Taipei

10060

Fondazione Del Piemonte Per L Oncologia Ircc Candiolo, Candiolo

12462

University Hospital of West Attica - Attikon, Chaïdári

13496

Cha Bundang Medical Center, Seongnam-si

17007

Ico Girona Hospital Universitari de Girona Dr Josep Trueta, Girona

19111

Fox Chase Cancer Center, Philadelphia

20057

Georgetown University, Washington D.C.

20133

Fondazione Irccs Istituto Nazionale Del Tumori Di Milano, Milan

20141

European Institute of Oncology, Milan

20246

Universitatsklinikum Hamburg Eppendorf, Hamburg

21201

University of Maryland-Greenebaum Cancer Center, Baltimore

22763

Asklepios Klinik Altona, Hamburg

22903

University of Virginia - Emily Couric Clinical Cancer Center, Charlottesville

27100

Fondazione Irccs Policlinico San Matteo, Pavia

28036

Hospital Universitario Ramon Y Cajal, Madrid

28223

Hospital Universitario Quironsalud Madrid, Madrid

29010

Hospital Regional Universitario Carlos Haya, Málaga

31008

Complejo Hospitalario de Navarra, Pamplona

32224

Mayo Clinic Jacksonville, Jacksonville

33000

Centre Hospitalier Universitaire de Bordeaux, Bordeaux

33174

Blessed Health Care, Miami

35042

Centre Eugene Marquis, Rennes

35128

Iov - Istituto Oncologico Veneto Irccs, Padua

39008

Hospital Universitario Marques de Valdecilla, Santander

42123

Ausl-Irccs Di Reggio Emilia, Reggio Emilia

44805

Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau, Saint-Herblain

46014

Hospital General Universitario de Valencia, Valencia

46026

Hospital Universitari I Politecnic La Fe, Valencia

48109

University of Michigan Cancer Center, Ann Arbor

48201

Barbara Ann Karmanos Cancer Hospital, Detroit

49241

Pusan National University Yangsan Hospital, Busan

50612

Pusan National University Yangsan Hospital, Yangsan

50937

University of Cologne, Cologne

54007

Theagenio Anticancer Hospital, Thessaloniki

54622

Bioclinic Thessaloniki (Galinos Clinic), Thessaloniki

55131

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii, Mainz

55236

Saint Lukas Clinic, Thessaloniki

58128

Chonnam National University Hwasun Hospital, Gwangju

60612

University of Illinois At Chicago, Chicago

66103

University of Kansas Hospital Authority, Kansas City

67200

Icans - Institut de Cancerologie Strasbourg Europe, Strasbourg

75248

Institut Curie, Paris

80131

Istituto Nazionale Tumori Irccs Fondazione Pascale, Naples

80708

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

83301

Chang Gung Medical Foundation. Kaohsiung Branch, Kaohsiung City

84112

Huntsman Cancer Institute At University of Utah, Salt Lake City

85259

Mayo Clinic Rochester, Scottsdale

90805

Innovative Clinical Research Institute, Long Beach

90813

City of Hope National Medical Center, Long Beach

92093

University of California San Diego Medical Center, Moores Cancer Center, La Jolla

92618

City of Hope Orange County, Irvine

93534

City of Hope-Antelope Valley, Lancaster

94115

University of California San Francisco Comprehensive Cancer Center, San Francisco

99336

Kadlec Clinic Hematology and Oncology, Kennewick

91010-9200

City of Hope National Medical Center, Duarte

33612-9416

Moffitt Cancer Center, Tampa

52242-1316

University of Iowa, Iowa City

02215

Dana Farber Cancer Institute, Boston

07601

Hackensack University Medical Center, Hackensack

06000

Grand Hospital de Charleroi, Charleroi

03500

Jessa Ziekenhuis, Hasselt

02610

Gza Sint Augustinus, Wilrijk

H2X 3E4

McGill University Health Centre/Glen Site/Cedars Cancer Centre, Montreal

H2X3E4

Chum Hospital Notre Dame, Montreal

H3T 1E2

McGill University Jewish General Hospital, Montreal

04600

Jsc Evex Hospitals, K'ut'aisi

00114

New Hospitals, Tbilisi

00159

Jsc Evex Corporation-Caraps Medline, Tbilisi

0159

Ltd Cancer Research Centre, Tbilisi

1066 CX

The Dutch Cancer Institue, Amsterdam

02333

Leids Universitair Medisch Centrum (Lumc) (Leiden University Medical Center), Leiden

85-796

Centrum Onkologii Im. Prof. Franciszka Lukaszczyka, Bydgoszcz

62-500

Przychodnia Lekarska Komed Roman Karaszewski, Konin

20-090

Centrum Onkologii Ziemi Lubelskiej Im. SW. Jana Z Dukli, Lublin

60-780

Poznan University of Medical Sciences, Poznan

97-200

Nzoz Provita Prolife Centrum Medyczne, Tomaszów Mazowiecki

02-781

Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie, Warsaw

4710-243

Hospital de Braga, Braga

8000-386

Centro Hospitalar Universitario Algarve, Faro

1649-035

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

4200-072

Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E., Porto

4200-319

Centro Hospitalar de Sao Joao Alameda, Porto

4434-502

Centro Hospitalar de Vila Nova de Gaia/Espinho, Epe-Unidade L, Vila Nova de Gaia

02841

Korea University Anam Hospital, Seoul

03181

Kangbuk Samsung Hospital, Seoul

05030

Kunkuk University Medical Center, Seoul

05505

Asan Medical Center, Seoul

08916

Catalans Institute of Oncology Barcelona, Barcelona

00034

Fundacion Jimenez Diaz University Hospital, Madrid

00112

China Medical University Hospital, Taichung

Institutional Review Board Taipei Veterans General Hospital, Taipei

All Listed Sponsors
lead

Incyte Biosciences International Sàrl

INDUSTRY