drugset / Trial / NCT05287113

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

Phase 2 Active not recruiting 176 enrolled Incyte Corporation
RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start
2022-11-14
Primary completion
2025-03-14
Completion
2026-07-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Retifanlimab Monoclonal antibody 500 mg Intravenous
Subject Tuparstobart Monoclonal antibody 350 mg Intravenous
Subject Verzistobart Monoclonal antibody 400 mg Intravenous

Indications