{"entity":{"id":"c-144-01","kind":"trial","name":"C-144-01","aka":[],"tldr":"The single-arm study that got the first cell therapy for a solid tumour approved: one in three patients responded after everything else had failed.","summary":"C-144-01, trial NCT02360579 sponsored by Iovance and reported in 2021, is the single-arm study that got the first cell therapy for a solid tumour approved: one in three patients with advanced melanoma that had progressed after anti-PD-1 therapy, and BRAF and MEK inhibitors where applicable, responded to a single infusion of lifileucel tumour-infiltrating lymphocytes. In 153 patients the objective response rate in the pivotal cohort was 31.4 percent, and the five-year analysis showed a median duration of response of about three years with roughly a third of responders still responding, leading to accelerated FDA approval in February 2024. OnCo links it to melanoma, TIL therapy, lifileucel, Iovance and Amod A. Sarnaik, and the result is consistent with decades of NCI Surgery Branch TIL series. Randomised confirmation rests on TILVANCE-301 in the first line with pembrolizumab.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02360579","url":"https://clinicaltrials.gov/study/NCT02360579"}],"tags":[],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["til-therapy"],"targets":[],"drugs":["lifileucel"],"companies":["iovance"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["amod-sarnaik"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02360579","phase":"2","setting":"Advanced melanoma progressing after anti-PD-1 (and BRAF/MEK if applicable): single infusion of lifileucel TIL","sponsor":"Iovance","result":"ORR 31.4%; median DOR 36.5 months (5-year analysis).","started":"2015-09-24","startedType":"actual","yearReported":2021,"enrolled":153,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Lifileucel","n":153,"value":31.4}],"source":"https://www.iovance.com"}],"replication":"Consistent with decades of NCI Surgery Branch TIL series; randomised confirmation pending (TILVANCE-301)."},"route":"/trials/c-144-01/","neighbours":{"cancer":[{"id":"advanced-melanoma","kind":"cancer","name":"Advanced melanoma (unresectable stage III and stage IV)","route":"/cancers/advanced-melanoma/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"}],"technology":[{"id":"til-therapy","kind":"technology","name":"TIL therapy","route":"/technologies/til-therapy/"}],"drug":[{"id":"lifileucel","kind":"drug","name":"Lifileucel","route":"/drugs/lifileucel/"}],"company":[{"id":"iovance","kind":"company","name":"Iovance Biotherapeutics","route":"/companies/iovance/"}],"person":[{"id":"amod-sarnaik","kind":"person","name":"Amod A. Sarnaik","route":"/people/amod-sarnaik/"}],"paper":[{"id":"paper-c-144-01-lifileucel-melanoma-jco-2021","kind":"paper","name":"C-144-01: lifileucel, tumour-infiltrating lymphocytes grown from a patient's own tumour, in melanoma after checkpoint inhibitors have failed","route":"/key-papers/paper-c-144-01-lifileucel-melanoma-jco-2021/"}]}}