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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05287113
• Other study ID #: INCAGN 2385-203
• Status: Recruiting
• Phase: Phase 2
• Start date: November 14, 2022
• Est. completion date: September 15, 2024

Study information

• Verified date: February 2024
• Source: Incyte Corporation
• Contact: Incyte Corporation Call Center (US)
• Phone: 1.855.463.3463
• Email: medinfo[@]incyte.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: September 15, 2024
• Est. primary completion date: May 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Belgium	Grand Hospital de Charleroi	Charleroi
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	Gza Sint Augustinus	Wilrijk
Canada	Chum Hospital Notre Dame	Montreal	Quebec
Canada	McGill University Health Centre/Glen Site/Cedars Cancer Centre	Montreal	Quebec
Canada	McGill University Jewish General Hospital	Montreal	Quebec
France	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	St Herblain
France	Icans - Institut de Cancerologie Strasbourg Europe	Strasbourg
Georgia	Jsc Evex Hospitals	K'ut'aisi
Georgia	Jsc Evex Corporation-Caraps Medline	Tbilisi
Georgia	Ltd Cancer Research Centre	Tbilisi
Georgia	New Hospitals	Tbilisi
Germany	University of Cologne	Cologne
Germany	Asklepios Klinik Altona	Hamburg
Germany	Universitatsklinikum Hamburg Eppendorf	Hamburg
Germany	Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii	Mainz
Greece	University Hospital of West Attica - Attikon	Chaidari
Greece	Bioclinic Thessaloniki (Galinos Clinic)	Thessaloniki
Greece	Saint Lukas Clinic	Thessaloniki
Greece	Theagenio Anticancer Hospital	Thessaloniki
Italy	Fondazione Del Piemonte Per L Oncologia Ircc Candiolo	Candiolo
Italy	Fondazione Irccs Istituto Nazionale Del Tumori Di Milano	Milan
Italy	European Institute of Oncology	Milano
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
Korea, Republic of	Pusan National University Yangsan Hospital	Busan
Korea, Republic of	Chonnam National University Hwasun Hospital	Gwangju
Korea, Republic of	Cha Bundang Medical Center	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Kunkuk University Medical Center	Seoul
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan
Netherlands	The Dutch Cancer Institue	Amsterdam
Netherlands	Leids Universitair Medisch Centrum (Lumc) (Leiden University Medical Center)	Leiden
Poland	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	Tomaszow Mazowiecki
Poland	Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie	Warszawa
Portugal	Hospital de Braga	Braga
Portugal	Centro Hospitalar Universitario Algarve	Faro
Portugal	Centro Hospitalar de Lisboa Norte E.P.E. - Hospital de Santa Maria	Lisboa
Portugal	Centro Hospitalar de Sao Joao Alameda	Porto
Portugal	Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E.	Porto
Portugal	Centro Hospitalar de Vila Nova de Gaia/Espinho, Epe-Unidade L	Vila Nova de Gaia
Spain	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 Quironsalud Madrid	Madrid
Spain	Hospital Universitario Ramon Y Cajal	Madrid
Spain	Hospital Regional Universitario Carlos Haya	Malaga
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
Taiwan	Chang Gung Medical Foundation. Kaohsiung Branch	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung City
Taiwan	China Medical University Hospital	Taichung City
Taiwan	Institutional Review Board Taipei Veterans General Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
United States	University of Michigan Cancer Center	Ann Arbor	Michigan
United States	University of Maryland-Greenebaum Cancer Center	Baltimore	Maryland
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	University of Virginia - Emily Couric Clinical Cancer Center	Charlottesville	Virginia
United States	University of Illinois At Chicago	Chicago	Illinois
United States	Barbara Ann Karmanos Cancer Hospital	Detroit	Michigan
United States	City of Hope National Medical Center	Duarte	California
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	University of Iowa	Iowa City	Iowa
United States	City of Hope Orange County	Irvine	California
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	University of Kansas Hospital Authority	Kansas City	Kansas
United States	Kadlec Clinic Hematology and Oncology	Kennewick	Washington
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	City of Hope National Medical Center	Long Beach	California
United States	Innovative Clinical Research Institute	Long Beach	California
United States	Blessed Health Care	Miami	Florida
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 California San Francisco Comprehensive Cancer Center	San Francisco	California
United States	Mayo Clinic Rochester	Scottsdale	Arizona
United States	Moffitt Cancer Center	Tampa	Florida
United States	Georgetown University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Biosciences International Sàrl

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Georgia,  Germany,  Greece,  Italy,  Korea, Republic of,  Netherlands,  Poland,  Portugal,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	Defined as the interval between the date of first dose of study treatment and the earliest date of disease progression, based on investigator assessment per RECIST v1.1, or death due to any cause.	Up to 24 months
Secondary	Objective Response Rate (ORR)	Defined as having a Complete Response (CR) or Partial Response (PR), determined based on investigator assessment per RECIST v1.1.	Up to 24 months
Secondary	Duration of Response (DOR)	Defined as the time from earliest date of disease response (CR or PR) until earliest date of disease progression, based on investigator assessment per RECIST v1.1, or death from any cause if occurring sooner than progression.	Up to 24 months
Secondary	Disease Control Rate (DCR)	Defined as having CR, PR, or SD (= 6 months) as best response, based on investigator assessment per RECIST v1.1.	Up to 24 months
Secondary	Overall Survival (OS)	Defined as the interval between the date of the date of first dose of study treatment until death due to any cause.	Up to 36 months
Secondary	Participants with treatment-emergent adverse events (TEAE)	TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug	Up to 24 months