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

NCT05287113 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 3 other identifiers: INCAGN 2385-2032023-504270-38-002021-005775-39
• Study Type: interventional
• Target: 176
• Locations: 14 countries
• Sites: 91

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).

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

Outcome Measures

Primary Outcomes (1)

• Progeression-free Survival (PFS)

  PFS was defined as the time from the date of randomization to the date of the first documented progression, as determined by investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), or death due to any cause, whichever occurred first.

  up to 738 days

Secondary Outcomes (6)

• Objective Response

  up to approximately 44 months

• Duration of Response (DOR)

  up to approximately 44 months

• Disease Control

  up to approximately 44 months

• Overall Survival

  up to approximately 44 months

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  up to approximately 44 months

Study Arms (3)

Treatment Group 1: Retifanlimab Monotherapy

EXPERIMENTAL

Retifanlimab will be administered intravenously every 4 weeks. Placebos for INCAGN02385 and INCAGN02390 will be administered intravenously every 2 weeks.

Drug: Retifanlimab; Drug: Placebo

Treatment Group 2: Retifanlimab + INCAGN02385

EXPERIMENTAL

Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and Placebo for INCAGN02390 will be administered intravenously every 2 weeks.

Drug: Retifanlimab; Drug: INCAGN02385; Drug: Placebo

Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390

EXPERIMENTAL

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.

Drug: Retifanlimab; Drug: INCAGN02385; Drug: INCAGN02390

Interventions

Retifanlimab DRUG

Retifanlimab 500mg will be administered intravenously every 4 weeks.

Treatment Group 1: Retifanlimab Monotherapy; Treatment Group 2: Retifanlimab + INCAGN02385; Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390

INCAGN02385 DRUG

INCAGN02385 350mg will be administered intravenously every 2 weeks.

Treatment Group 2: Retifanlimab + INCAGN02385; Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390

INCAGN02390 DRUG

INCAGN02390 400 mg will be administered intravenously every 2 weeks.

Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390

Placebo DRUG

Placebo will be administered intravenously.

Treatment Group 1: Retifanlimab Monotherapy; Treatment Group 2: Retifanlimab + INCAGN02385

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Biosciences International Sàrl: lead

Study Sites (91)

Mayo Clinic Rochester

Scottsdale, Arizona, 85259, United States

Location

City of Hope National Medical Center

Duarte, California, 91010-9200, United States

Location

City of Hope Orange County

Irvine, California, 92618, United States

Location

University of California San Diego Medical Center, Moores Cancer Center

La Jolla, California, 92093, United States

Location

City of Hope-Antelope Valley

Lancaster, California, 93534, United States

Location

Innovative Clinical Research Institute

Long Beach, California, 90805, United States

Location

City of Hope National Medical Center

Long Beach, California, 90813, United States

Location

University of California San Francisco Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Blessed Health Care

Miami, Florida, 33174, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612-9416, United States

Location

University of Illinois At Chicago

Chicago, Illinois, 60612, United States

Location

University of Iowa

Iowa City, Iowa, 52242-1316, United States

Location

University of Kansas Hospital Authority

Kansas City, Kansas, 66103, United States

Location

University of Maryland-Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Barbara Ann Karmanos Cancer Hospital

Detroit, Michigan, 48201, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Huntsman Cancer Institute At University of Utah

Salt Lake City, Utah, 84112, United States

Location

University of Virginia - Emily Couric Clinical Cancer Center

Charlottesville, Virginia, 22903, United States

Location

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336, United States

Location

Grand Hospital de Charleroi

Charleroi, 06000, Belgium

Location

Jessa Ziekenhuis

Hasselt, 03500, Belgium

Location

Gza Sint Augustinus

Wilrijk, 02610, Belgium

Location

McGill University Health Centre/Glen Site/Cedars Cancer Centre

Montreal, Quebec, H2X 3E4, Canada

Location

Chum Hospital Notre Dame

Montreal, Quebec, H2X3E4, Canada

Location

McGill University Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33000, France

Location

Institut Curie

Paris, 75248, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

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

Saint-Herblain, 44805, France

Location

Icans - Institut de Cancerologie Strasbourg Europe

Strasbourg, 67200, France

Location

Jsc Evex Hospitals

K'ut'aisi, 04600, Georgia

Location

New Hospitals

Tbilisi, 00114, Georgia

Location

Jsc Evex Corporation-Caraps Medline

Tbilisi, 00159, Georgia

Location

Ltd Cancer Research Centre

Tbilisi, 0159, Georgia

Location

University of Cologne

Cologne, 50937, Germany

Location

Universitatsklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Asklepios Klinik Altona

Hamburg, 22763, Germany

Location

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

Mainz, 55131, Germany

Location

University Hospital of West Attica - Attikon

Chaïdári, 12462, Greece

Location

Theagenio Anticancer Hospital

Thessaloniki, 54007, Greece

Location

Bioclinic Thessaloniki (Galinos Clinic)

Thessaloniki, 54622, Greece

Location

Saint Lukas Clinic

Thessaloniki, 55236, Greece

Location

Fondazione Del Piemonte Per L Oncologia Ircc Candiolo

Candiolo, 10060, Italy

Location

Fondazione Irccs Istituto Nazionale Del Tumori Di Milano

Milan, 20133, Italy

Location

European Institute of Oncology

Milan, 20141, Italy

Location

Istituto Nazionale Tumori Irccs Fondazione Pascale

Naples, 80131, Italy

Location

Iov - Istituto Oncologico Veneto Irccs

Padua, 35128, Italy

Location

Fondazione Irccs Policlinico San Matteo

Pavia, 27100, Italy

Location

Ausl-Irccs Di Reggio Emilia

Reggio Emilia, 42123, Italy

Location

The Dutch Cancer Institue

Amsterdam, 1066 CX, Netherlands

Location

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

Leiden, 02333, Netherlands

Location

Centrum Onkologii Im. Prof. Franciszka Lukaszczyka

Bydgoszcz, 85-796, Poland

Location

Przychodnia Lekarska Komed Roman Karaszewski

Konin, 62-500, Poland

Location

Centrum Onkologii Ziemi Lubelskiej Im. SW. Jana Z Dukli

Lublin, 20-090, Poland

Location

Poznan University of Medical Sciences

Poznan, 60-780, Poland

Location

Nzoz Provita Prolife Centrum Medyczne

Tomaszów Mazowiecki, 97-200, Poland

Location

Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie

Warsaw, 02-781, Poland

Location

Hospital de Braga

Braga, 4710-243, Portugal

Location

Centro Hospitalar Universitario Algarve

Faro, 8000-386, Portugal

Location

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

Lisbon, 1649-035, Portugal

Location

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

Porto, 4200-072, Portugal

Location

Centro Hospitalar de Sao Joao Alameda

Porto, 4200-319, Portugal

Location

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

Vila Nova de Gaia, 4434-502, Portugal

Location

Pusan National University Yangsan Hospital

Busan, 49241, South Korea

Location

Chonnam National University Hwasun Hospital

Gwangju, 58128, South Korea

Location

Cha Bundang Medical Center

Seongnam-si, 13496, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Kunkuk University Medical Center

Seoul, 05030, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

Location

Catalans Institute of Oncology Barcelona

Barcelona, 08916, Spain

Location

Ico Girona Hospital Universitari de Girona Dr Josep Trueta

Girona, 17007, Spain

Location

Fundacion Jimenez Diaz University Hospital

Madrid, 00034, Spain

Location

Hospital Universitario Ramon Y Cajal

Madrid, 28036, Spain

Location

Hospital Universitario Quironsalud Madrid

Madrid, 28223, Spain

Location

Hospital Regional Universitario Carlos Haya

Málaga, 29010, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, 31008, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Hospital Universitari I Politecnic La Fe

Valencia, 46026, Spain

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80708, Taiwan

Location

Chang Gung Medical Foundation. Kaohsiung Branch

Kaohsiung City, 83301, Taiwan

Location

China Medical University Hospital

Taichung, 00112, Taiwan

Location

Institutional Review Board Taipei Veterans General Hospital

Taipei, 00112, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Related Links

• 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

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Model Details: Patients will be randomized to 1 of 3 treatment groups.

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 18, 2022
• Study Start: November 14, 2022
• Primary Completion: March 14, 2025
• Study Completion (Estimated): July 10, 2026
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

FR (5); KR (8); BE (3); IT (7); CA (3); PL (6); TW (5); GE (4); US (24); ES (10); DE (4); GR (4); NL (2); PT (6)