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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Head and Neck Cancer

In brief

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).

Key facts

Study ID

NCT05287113

Run by

Incyte Biosciences International Sàrl

People needed

176

Starts

2022-11-14

Expected to finish

2026-07-10

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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
• Blessed Health Care — Miami, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• University of Illinois At Chicago — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kansas Hospital Authority — Kansas City, Kansas, United States
• University of Maryland-Greenebaum Cancer Center — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Cancer Center — Ann Arbor, Michigan, United States
• Barbara Ann Karmanos Cancer Hospital — Detroit, Michigan, United States
• Hackensack University Medical Center — Hackensack, New Jersey, 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 Virginia - Emily Couric Clinical Cancer Center — Charlottesville, Virginia, United States
• Kadlec Clinic Hematology and Oncology — Kennewick, Washington, United States
• Grand Hospital de Charleroi — Charleroi, Belgium
• Mayo Clinic Rochester — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.