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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 | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

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

NCT05287113•Incyte Biosciences International Sàrl

View on ClinicalTrials.gov

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

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

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.

Locations (91)

Mayo Clinic Rochester

Scottsdale, Arizona, United States

City of Hope National Medical Center

Duarte, California, United States

City of Hope Orange County

Irvine, California, 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

Innovative Clinical Research Institute

Long Beach, California, United States

City of Hope National Medical Center

Long Beach, California, United States

University of California San Francisco Comprehensive Cancer Center

San Francisco, California, United States

Georgetown University

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

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Key Dates

Start Date

November 14, 2022

Primary Completion Date

March 14, 2025

Completion Date

July 10, 2026

Last Updated

January 7, 2026

Enrollment

176

ACTUAL participants

Conditions

Head and Neck Cancer

Interventions

Retifanlimab

DRUG

INCAGN02385

DRUG

INCAGN02390

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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