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

Trial 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

NCT ID: NCT05287113

Condition: Head and Neck Cancer

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck

Conditions: Keywords:
squamous cell carcinoma of the head and neck (SCCHN)
INCAGN02385
INCAGN02390
Retifanlimab
IgG1κ monoclonal antibody
LAG-3
TIM-3
PD-1
PD-L1

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Patients will be randomized to 1 of 3 treatment groups.

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Intervention:

Intervention type: Drug
Intervention name: Retifanlimab
Description: Retifanlimab 500mg will be administered intravenously every 4 weeks.
Arm group label: Treatment Group 1: Retifanlimab Monotherapy
Arm group label: Treatment Group 2: Retifanlimab + INCAGN02385
Arm group label: Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390

Intervention type: Drug
Intervention name: INCAGN02385
Description: INCAGN02385 350mg will be administered intravenously every 2 weeks.
Arm group label: Treatment Group 2: Retifanlimab + INCAGN02385
Arm group label: Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390

Intervention type: Drug
Intervention name: INCAGN02390
Description: INCAGN02390 400 mg will be administered intravenously every 2 weeks.
Arm group label: Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390

Intervention type: Drug
Intervention name: Placebo
Description: Placebo will be administered intravenously.
Arm group label: Treatment Group 1: Retifanlimab Monotherapy
Arm group label: Treatment Group 2: Retifanlimab + INCAGN02385

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).

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Histologically or cytologically confirmed R/M SCCHN that is not amenable to therapy with curative intent. Participants who refuse potentially curative salvage surgery for recurrent disease are ineligible. - 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: - Progressive or recurrent disease within 6 months of the last dose of systemic treatment for locally advanced SCCHN. Prior PD-(L)1, LAG-3, or TIM-3 directed therapy, or any other checkpoint inhibitor therapy, for SCCHN or any other malignancy. - 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.

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Locations:

Facility:
Name: Mayo Clinic Rochester

Address:
City: Scottsdale
Zip: 85259
Country: United States

Facility:
Name: City of Hope National Medical Center

Address:
City: Duarte
Zip: 91010-9200
Country: United States

Facility:
Name: City of Hope Orange County

Address:
City: Irvine
Zip: 92618
Country: United States

Facility:
Name: University of California San Diego Medical Center, Moores Cancer Center

Address:
City: La Jolla
Zip: 92093
Country: United States

Facility:
Name: City of Hope-Antelope Valley

Address:
City: Lancaster
Zip: 93534
Country: United States

Facility:
Name: Innovative Clinical Research Institute

Address:
City: Long Beach
Zip: 90805
Country: United States

Facility:
Name: City of Hope National Medical Center

Address:
City: Long Beach
Zip: 90813
Country: United States

Facility:
Name: University of California San Francisco Comprehensive Cancer Center

Address:
City: San Francisco
Zip: 94115
Country: United States

Facility:
Name: Georgetown University

Address:
City: Washington
Zip: 20057
Country: United States

Facility:
Name: Mayo Clinic Jacksonville

Address:
City: Jacksonville
Zip: 32224
Country: United States

Facility:
Name: Blessed Health Care

Address:
City: Miami
Zip: 33174
Country: United States

Facility:
Name: Moffitt Cancer Center

Address:
City: Tampa
Zip: 33612-9416
Country: United States

Facility:
Name: University of Illinois At Chicago

Address:
City: Chicago
Zip: 60612
Country: United States

Facility:
Name: University of Iowa

Address:
City: Iowa City
Zip: 52242-1316
Country: United States

Facility:
Name: University of Kansas Hospital Authority

Address:
City: Kansas City
Zip: 66103
Country: United States

Facility:
Name: University of Maryland-Greenebaum Cancer Center

Address:
City: Baltimore
Zip: 21201
Country: United States

Facility:
Name: Dana Farber Cancer Institute

Address:
City: Boston
Zip: 02215
Country: United States

Facility:
Name: University of Michigan Cancer Center

Address:
City: Ann Arbor
Zip: 48109
Country: United States

Facility:
Name: Barbara Ann Karmanos Cancer Hospital

Address:
City: Detroit
Zip: 48201
Country: United States

Facility:
Name: Hackensack University Medical Center

Address:
City: Hackensack
Zip: 07601
Country: United States

Facility:
Name: Fox Chase Cancer Center

Address:
City: Philadelphia
Zip: 19111
Country: United States

Facility:
Name: Huntsman Cancer Institute At University of Utah

Address:
City: Salt Lake City
Zip: 84112
Country: United States

Facility:
Name: University of Virginia - Emily Couric Clinical Cancer Center

Address:
City: Charlottesville
Zip: 22903
Country: United States

Facility:
Name: Kadlec Clinic Hematology and Oncology

Address:
City: Kennewick
Zip: 99336
Country: United States

Facility:
Name: Grand Hospital de Charleroi

Address:
City: Charleroi
Zip: 06000
Country: Belgium

Facility:
Name: Jessa Ziekenhuis

Address:
City: Hasselt
Zip: 03500
Country: Belgium

Facility:
Name: Gza Sint Augustinus

Address:
City: Wilrijk
Zip: 02610
Country: Belgium

Facility:
Name: McGill University Health Centre/Glen Site/Cedars Cancer Centre

Address:
City: Montreal
Zip: H2X 3E4
Country: Canada

Facility:
Name: Chum Hospital Notre Dame

Address:
City: Montreal
Zip: H2X3E4
Country: Canada

Facility:
Name: McGill University Jewish General Hospital

Address:
City: Montreal
Zip: H3T 1E2
Country: Canada

Facility:
Name: Centre Hospitalier Universitaire de Bordeaux

Address:
City: Bordeaux
Zip: 33000
Country: France

Facility:
Name: Institut Curie

Address:
City: Paris
Zip: 75248
Country: France

Facility:
Name: Centre Eugene Marquis

Address:
City: Rennes
Zip: 35042
Country: France

Facility:
Name: Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau

Address:
City: St Herblain
Zip: 44805
Country: France

Facility:
Name: Icans - Institut de Cancerologie Strasbourg Europe

Address:
City: Strasbourg
Zip: 67200
Country: France

Facility:
Name: Jsc Evex Hospitals

Address:
City: K'ut'aisi
Zip: 04600
Country: Georgia

Facility:
Name: New Hospitals

Address:
City: Tbilisi
Zip: 00114
Country: Georgia

Facility:
Name: Jsc Evex Corporation-Caraps Medline

Address:
City: Tbilisi
Zip: 00159
Country: Georgia

Facility:
Name: Ltd Cancer Research Centre

Address:
City: Tbilisi
Zip: 0159
Country: Georgia

Facility:
Name: University of Cologne

Address:
City: Cologne
Zip: 50937
Country: Germany

Facility:
Name: Universitatsklinikum Hamburg Eppendorf

Address:
City: Hamburg
Zip: 20246
Country: Germany

Facility:
Name: Asklepios Klinik Altona

Address:
City: Hamburg
Zip: 22763
Country: Germany

Facility:
Name: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

Address:
City: Mainz
Zip: 55131
Country: Germany

Facility:
Name: University Hospital of West Attica - Attikon

Address:
City: Chaidari
Zip: 12462
Country: Greece

Facility:
Name: Theagenio Anticancer Hospital

Address:
City: Thessaloniki
Zip: 54007
Country: Greece

Facility:
Name: Bioclinic Thessaloniki (Galinos Clinic)

Address:
City: Thessaloniki
Zip: 54622
Country: Greece

Facility:
Name: Saint Lukas Clinic

Address:
City: Thessaloniki
Zip: 55236
Country: Greece

Facility:
Name: Fondazione Del Piemonte Per L Oncologia Ircc Candiolo

Address:
City: Candiolo
Zip: 10060
Country: Italy

Facility:
Name: European Institute of Oncology

Address:
City: Milano
Zip: 20141
Country: Italy

Facility:
Name: Fondazione Irccs Istituto Nazionale Del Tumori Di Milano

Address:
City: Milan
Zip: 20133
Country: Italy

Facility:
Name: Istituto Nazionale Tumori Irccs Fondazione Pascale

Address:
City: Naples
Zip: 80131
Country: Italy

Facility:
Name: Iov - Istituto Oncologico Veneto Irccs

Address:
City: Padova
Zip: 35128
Country: Italy

Facility:
Name: Fondazione Irccs Policlinico San Matteo

Address:
City: Pavia
Zip: 27100
Country: Italy

Facility:
Name: Ausl-Irccs Di Reggio Emilia

Address:
City: Reggio Emilia
Zip: 42123
Country: Italy

Facility:
Name: Pusan National University Yangsan Hospital

Address:
City: Busan
Zip: 49241
Country: Korea, Republic of

Facility:
Name: Chonnam National University Hwasun Hospital

Address:
City: Gwangju
Zip: 58128
Country: Korea, Republic of

Facility:
Name: Cha Bundang Medical Center

Address:
City: Seongnam-si
Zip: 13496
Country: Korea, Republic of

Facility:
Name: Korea University Anam Hospital

Address:
City: Seoul
Zip: 02841
Country: Korea, Republic of

Facility:
Name: Kangbuk Samsung Hospital

Address:
City: Seoul
Zip: 03181
Country: Korea, Republic of

Facility:
Name: Kunkuk University Medical Center

Address:
City: Seoul
Zip: 05030
Country: Korea, Republic of

Facility:
Name: Asan Medical Center

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Facility:
Name: Pusan National University Yangsan Hospital

Address:
City: Yangsan
Zip: 50612
Country: Korea, Republic of

Facility:
Name: The Dutch Cancer Institue

Address:
City: Amsterdam
Zip: 1066 CX
Country: Netherlands

Facility:
Name: Leids Universitair Medisch Centrum (Lumc) (Leiden University Medical Center)

Address:
City: Leiden
Zip: 02333
Country: Netherlands

Facility:
Name: Centrum Onkologii Im. Prof. Franciszka Lukaszczyka

Address:
City: Bydgoszcz
Zip: 85-796
Country: Poland

Facility:
Name: Przychodnia Lekarska Komed Roman Karaszewski

Address:
City: Konin
Zip: 62-500
Country: Poland

Facility:
Name: Centrum Onkologii Ziemi Lubelskiej Im. SW. Jana Z Dukli

Address:
City: Lublin
Zip: 20-090
Country: Poland

Facility:
Name: Poznan University of Medical Sciences

Address:
City: Poznan
Zip: 60-780
Country: Poland

Facility:
Name: Nzoz Provita Prolife Centrum Medyczne

Address:
City: Tomaszow Mazowiecki
Zip: 97-200
Country: Poland

Facility:
Name: Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie

Address:
City: Warszawa
Zip: 02-781
Country: Poland

Facility:
Name: Hospital de Braga

Address:
City: Braga
Zip: 4710-243
Country: Portugal

Facility:
Name: Centro Hospitalar Universitario Algarve

Address:
City: Faro
Zip: 8000-386
Country: Portugal

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

Address:
City: Lisboa
Zip: 1649-035
Country: Portugal

Facility:
Name: Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E.

Address:
City: Porto
Zip: 4200-072
Country: Portugal

Facility:
Name: Centro Hospitalar de Sao Joao Alameda

Address:
City: Porto
Zip: 4200-319
Country: Portugal

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

Address:
City: Vila Nova de Gaia
Zip: 4434-502
Country: Portugal

Facility:
Name: Catalans Institute of Oncology Barcelona

Address:
City: Barcelona
Zip: 08916
Country: Spain

Facility:
Name: Ico Girona Hospital Universitari de Girona Dr Josep Trueta

Address:
City: Girona
Zip: 17007
Country: Spain

Facility:
Name: Fundacion Jimenez Diaz University Hospital

Address:
City: Madrid
Zip: 00034
Country: Spain

Facility:
Name: Hospital Universitario Ramon Y Cajal

Address:
City: Madrid
Zip: 28036
Country: Spain

Facility:
Name: Hospital Universitario Quironsalud Madrid

Address:
City: Madrid
Zip: 28223
Country: Spain

Facility:
Name: Hospital Regional Universitario Carlos Haya

Address:
City: Malaga
Zip: 29010
Country: Spain

Facility:
Name: Complejo Hospitalario de Navarra

Address:
City: Pamplona
Zip: 31008
Country: Spain

Facility:
Name: Hospital Universitario Marques de Valdecilla

Address:
City: Santander
Zip: 39008
Country: Spain

Facility:
Name: Hospital General Universitario de Valencia

Address:
City: Valencia
Zip: 46014
Country: Spain

Facility:
Name: Hospital Universitari I Politecnic La Fe

Address:
City: Valencia
Zip: 46026
Country: Spain

Facility:
Name: Kaohsiung Medical University Chung-Ho Memorial Hospital

Address:
City: Kaohsiung City
Zip: 80708
Country: Taiwan

Facility:
Name: Chang Gung Medical Foundation. Kaohsiung Branch

Address:
City: Kaohsiung
Zip: 83301
Country: Taiwan

Facility:
Name: China Medical University Hospital

Address:
City: Taichung City
Zip: 00112
Country: Taiwan

Facility:
Name: Institutional Review Board Taipei Veterans General Hospital

Address:
City: Taipei
Zip: 00112
Country: Taiwan

Facility:
Name: National Taiwan University Hospital

Address:
City: Taipei
Zip: 10002
Country: Taiwan

Start date: November 14, 2022

Completion date: June 30, 2025

Lead sponsor:
Agency: Incyte Biosciences International Sàrl
Agency class: Industry

Source: Incyte Corporation

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05287113