CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 176 enrolled
Drug / intervention
Retifanlimab +3 moredrug
Likely dose
Retifanlimab 500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05287113
NCT05287113Phase 2Active

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

Incyte Biosciences International Sàrl·interventional·Posted Mar 18, 2022·Updated Mar 27, 2026

In Brief

A Phase 2 clinical trial evaluating Retifanlimab, INCAGN02385, and 2 other interventions for Head and Neck Cancer. Active but no longer recruiting, targeting 176 participants across 91 sites in 14 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Canada, France, Georgia, Germany, Greece, Italy, Netherlands, Poland, Portugal, South Korea, Spain, Taiwan, United States
Collaborators--

Timeline

Phase 2Active
2023202420252026
First PostedMar 18, 2022
Enrollment StartNov 14, 2022
Primary CompletionMar 14, 2025
Study CompletionJul 10, 2026
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 4.3 years ago

Interventions

Retifanlimabdrug

Retifanlimab 500mg will be administered intravenously every 4 weeks.

INCAGN02385drug

INCAGN02385 350mg will be administered intravenously every 2 weeks.

INCAGN02390drug

INCAGN02390 400 mg will be administered intravenously every 2 weeks.

Placebodrug

Placebo will be administered intravenously.