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INCAGN2385-203 - 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

Studio Clinico

Patologia: Tumori della testa e del collo

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico


Fase di studio: II Randomizzato

Richiesta mandatoria di tessuto: 

Linee di trattamento: Prima linea

Criteri di inclusione: 

• 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.

Criteri di esclusione: 

• 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.
vTreatment 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.

Trattamento sperimentale: 

Retifanlimab, INCAGN02385, INCAGN02390

Trattamento di controllo: 


Centri partecipanti

Nord Italia

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
Oncologia Medica 3

Riferimento: Prof.ssa Lisa Licitra
Telefono: 0223902810


Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI


Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD


IRCCS Policlinico San Matteo
Viale Golgi 19 - 27100 Pavia - PV
NB: No longer recruiting


AUSL/IRCCS di Reggio Emilia
Viale Risorgimento 80 - 42123 Reggio nell'Emilia - RE


IRCCS Candiolo (TO)
St.Provinciale Km 3,95 SP142 - 10060 Candiolo - TO


Sud Italia e isole

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA

Informazioni Generali


Numero di iscrizione a registro: 2021-005775-39

Data di inserimento: 12.07.2023

Data di aggiornamento: 07.02.2024


Incyte Biosciences International Sàrl


Syneos Health

Principal Investigator ITALIA

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Riferimento: Prof.ssa Lisa Licitra

Telefono: 0223902810


Localita: Milano


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