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Clinical Trials in China / NCT05287113
Active, not recruiting Phase 2

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 · tracked via the Priya Life Science China tracker
Sponsor
Incyte Biosciences International Sàrl
Phase
Phase 2
Started
2022-11-14
Last updated
2026-03-27

Condition(s) studied

Head and Neck Cancer

Investigational drug(s) / intervention(s)

RetifanlimabINCAGN02385INCAGN02390Placebo

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (91)

FacilityCityRegionStatus
Mayo Clinic Rochester Scottsdale Arizona
City of Hope National Medical Center Duarte California
City of Hope Orange County Irvine California
University of California San Diego Medical Center, Moores Cancer Center La Jolla California
City of Hope-Antelope Valley Lancaster California
Innovative Clinical Research Institute Long Beach California
City of Hope National Medical Center Long Beach California
University of California San Francisco Comprehensive Cancer Center San Francisco California
Georgetown University Washington D.C. District of Columbia
Mayo Clinic Jacksonville Jacksonville Florida
Blessed Health Care Miami Florida
Moffitt Cancer Center Tampa Florida
University of Illinois At Chicago Chicago Illinois
University of Iowa Iowa City Iowa
University of Kansas Hospital Authority Kansas City Kansas
University of Maryland-Greenebaum Cancer Center Baltimore Maryland
Dana Farber Cancer Institute Boston Massachusetts
University of Michigan Cancer Center Ann Arbor Michigan
Barbara Ann Karmanos Cancer Hospital Detroit Michigan
Hackensack University Medical Center Hackensack New Jersey
Fox Chase Cancer Center Philadelphia Pennsylvania
Huntsman Cancer Institute At University of Utah Salt Lake City Utah
University of Virginia - Emily Couric Clinical Cancer Center Charlottesville Virginia
Kadlec Clinic Hematology and Oncology Kennewick Washington
Grand Hospital de Charleroi Charleroi Belgium
Jessa Ziekenhuis Hasselt Belgium
Gza Sint Augustinus Wilrijk Belgium
McGill University Health Centre/Glen Site/Cedars Cancer Centre Montreal Quebec
Chum Hospital Notre Dame Montreal Quebec
McGill University Jewish General Hospital Montreal Quebec
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 Saint-Herblain France
Icans - Institut de Cancerologie Strasbourg Europe Strasbourg France
Jsc Evex Hospitals K'ut'aisi Georgia
New Hospitals Tbilisi Georgia
Jsc Evex Corporation-Caraps Medline Tbilisi Georgia
Ltd Cancer Research Centre Tbilisi Georgia
University of Cologne Cologne Germany

+ 51 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05287113 on ClinicalTrials.gov ↗ ← All trials in China