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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Incyte Biosciences International Sàrl · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Retifanlimab	Retifanlimab 500mg will be administered intravenously every 4 weeks.
DRUG	INCAGN02385	INCAGN02385 350mg will be administered intravenously every 2 weeks.
DRUG	INCAGN02390	INCAGN02390 400 mg will be administered intravenously every 2 weeks.
DRUG	Placebo	Placebo will be administered intravenously.

Timeline

• Start date: 2022-11-14
• Primary completion: 2025-03-14
• Completion: 2026-07-10
• First posted: 2022-03-18
• Last updated: 2026-03-27
• Results posted: 2026-03-27

Locations

91 sites across 14 countries: United States, Belgium, Canada, France, Georgia, Germany, Greece, Italy, Netherlands, Poland, Portugal, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study