{"entity":{"id":"nct05287113","kind":"trial","name":"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","aka":[],"tldr":"A phase 2 trial of Retifanlimab in head and neck squamous cell carcinoma, run by Incyte Biosciences International Sàrl, active and no longer recruiting.","summary":"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 is a phase 2 interventional study registered as NCT05287113 by Incyte Biosciences International Sàrl, with 176 participants enrolled, started 2022-11-14 and due to reach its primary completion in 2025-03-14. Interventions recorded: Retifanlimab, INCAGN02385, INCAGN02390 and Placebo. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05287113","url":"https://clinicaltrials.gov/study/NCT05287113"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["retifanlimab"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05287113","phase":"2","setting":"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","sponsor":"Incyte Biosciences International Sàrl","started":"2022-11-14","startedType":"actual","yearReported":2026,"enrolled":176,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progeression-free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Retifanlimab","n":59,"value":5.6,"note":"95% CI 3.5 to 9.7; Figures from the ClinicalTrials.gov results section (first posted 2026-03-27), not from a publication"},{"name":"Retifanlimab Plus INCAGN02385","n":60,"value":5.8,"note":"95% CI 3.7 to 7.6"},{"name":"Retifanlimab Plus INCAGN02385 Plus INCAGN02390","n":57,"value":5.3,"note":"95% CI 2.1 to 7.9"}],"source":"https://clinicaltrials.gov/study/NCT05287113?tab=results"}]},"route":"/trials/nct05287113/","neighbours":{"cancer":[{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"recurrent-metastatic-hnscc","kind":"cancer","name":"Recurrent or metastatic head and neck squamous cell carcinoma","route":"/cancers/recurrent-metastatic-hnscc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"retifanlimab","kind":"drug","name":"Retifanlimab","route":"/drugs/retifanlimab/"}],"company":[{"id":"incyte","kind":"company","name":"Incyte","route":"/companies/incyte/"}]}}