Clinical trial NCT05287113: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: squamous cell carcinoma of the head and neck (SCCHN)
INCAGN02385
INCAGN02390
Retifanlimab
IgG1κ monoclonal antibody
LAG-3
TIM-3
PD-1
PD-L1
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2022-03-18
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to 1 of 3 treatment groups.
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Up to 24 months
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 24 months
measure: Duration of Response (DOR)
timeFrame: Up to 24 months
measure: Disease Control Rate (DCR)
timeFrame: Up to 24 months
measure: Overall Survival (OS)
timeFrame: Up to 36 months
measure: Participants with treatment-emergent adverse events (TEAE)
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Rochester
state: Arizona
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Irvine
country: United States
facility: City of Hope Orange County
state: California
city: La Jolla
country: United States
facility: University of California San Diego Medical Center, Moores Cancer Center
state: California
city: Lancaster
country: United States
facility: City of Hope-Antelope Valley
state: California
city: Long Beach
country: United States
facility: Innovative Clinical Research Institute
state: California
city: Long Beach
country: United States
facility: City of Hope National Medical Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Comprehensive Cancer Center
state: California
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Miami
country: United States
facility: Blessed Health Care
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: University of Illinois At Chicago
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Hospital Authority
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland-Greenebaum Cancer Center
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Hospital
state: Michigan
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute At University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia - Emily Couric Clinical Cancer Center
state: Virginia
city: Kennewick
country: United States
facility: Kadlec Clinic Hematology and Oncology
state: Washington
city: Charleroi
country: Belgium
facility: Grand Hospital de Charleroi
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Wilrijk
country: Belgium
facility: Gza Sint Augustinus
city: Montreal
country: Canada
facility: McGill University Health Centre/Glen Site/Cedars Cancer Centre
state: Quebec
city: Montreal
country: Canada
facility: Chum Hospital Notre Dame
state: Quebec
city: Montreal
country: Canada
facility: McGill University Jewish General Hospital
state: Quebec
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
city: Paris
country: France
facility: Institut Curie
city: Rennes
country: France
facility: Centre Eugene Marquis
city: St Herblain
country: France
facility: Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
city: Strasbourg
country: France
facility: Icans - Institut de Cancerologie Strasbourg Europe
city: K'ut'aisi
country: Georgia
facility: Jsc Evex Hospitals
city: Tbilisi
country: Georgia
facility: New Hospitals
city: Tbilisi
country: Georgia
facility: Jsc Evex Corporation-Caraps Medline
city: Tbilisi
country: Georgia
facility: Ltd Cancer Research Centre
city: Cologne
country: Germany
facility: University of Cologne
city: Hamburg
country: Germany
facility: Universitatsklinikum Hamburg Eppendorf
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Mainz
country: Germany
facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
city: Chaidari
country: Greece
facility: University Hospital of West Attica - Attikon
city: Thessaloniki
country: Greece
facility: Theagenio Anticancer Hospital
city: Thessaloniki
country: Greece
facility: Bioclinic Thessaloniki (Galinos Clinic)
city: Thessaloniki
country: Greece
facility: Saint Lukas Clinic
city: Candiolo
country: Italy
facility: Fondazione Del Piemonte Per L Oncologia Ircc Candiolo
city: Milano
country: Italy
facility: European Institute of Oncology
city: Milan
country: Italy
facility: Fondazione Irccs Istituto Nazionale Del Tumori Di Milano
city: Naples
country: Italy
facility: Istituto Nazionale Tumori Irccs Fondazione Pascale
city: Padova
country: Italy
facility: Iov - Istituto Oncologico Veneto Irccs
city: Pavia
country: Italy
facility: Fondazione Irccs Policlinico San Matteo
city: Reggio Emilia
country: Italy
facility: Ausl-Irccs Di Reggio Emilia
city: Busan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Cha Bundang Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Kunkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Amsterdam
country: Netherlands
facility: The Dutch Cancer Institue
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum (Lumc) (Leiden University Medical Center)
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii Im. Prof. Franciszka Lukaszczyka
city: Konin
country: Poland
facility: Przychodnia Lekarska Komed Roman Karaszewski
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej Im. SW. Jana Z Dukli
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences
city: Tomaszow Mazowiecki
country: Poland
facility: Nzoz Provita Prolife Centrum Medyczne
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie
city: Braga
country: Portugal
facility: Hospital de Braga
city: Faro
country: Portugal
facility: Centro Hospitalar Universitario Algarve
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte E.P.E. - Hospital de Santa Maria
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E.
city: Porto
country: Portugal
facility: Centro Hospitalar de Sao Joao Alameda
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, Epe-Unidade L
city: Barcelona
country: Spain
facility: Catalans Institute of Oncology Barcelona
city: Girona
country: Spain
facility: Ico Girona Hospital Universitari de Girona Dr Josep Trueta
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz University Hospital
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Quironsalud Madrid
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari I Politecnic La Fe
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation. Kaohsiung Branch
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: Institutional Review Board Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: