{"entity":{"id":"imcgp100-202","kind":"trial","name":"IMCgp100-202","aka":[],"tldr":"The first drug ever to extend life in metastatic uveal melanoma, and the first T-cell receptor-based medicine to win a phase 3.","summary":"IMCgp100-202, trial NCT03070392 sponsored by Immunocore and reported in 2021, produced the first drug ever to extend life in metastatic uveal melanoma and the first T-cell receptor-based medicine to win a phase 3. It randomised 378 untreated HLA-A*02:01-positive patients to tebentafusp or investigator's choice of pembrolizumab, ipilimumab or dacarbazine and met its primary overall survival endpoint despite a low response rate, showing that circulating tumour DNA reduction and slowed growth matter more than RECIST shrinkage for this class; approval followed in January 2022, with cytokine release syndrome and rash manageable through step-up dosing. There is no second randomised trial, and whether the approach transfers to cutaneous melanoma, as PRISM-MEL-301 tests, is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03070392","url":"https://clinicaltrials.gov/study/NCT03070392"},{"label":"NEJM 2021","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2103485"}],"tags":[],"related":[],"cancers":["melanoma"],"sections":[],"technologies":["t-cell-engager"],"targets":["gp100","cd3"],"drugs":["tebentafusp"],"companies":["immunocore"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["paul-nathan","richard-carvajal"],"bottlenecks":[],"keyPapers":["paper-imcgp100-202-n-engl-j-med-2021","paper-imcgp100-202-n-engl-j-med-2023-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03070392","phase":"2","setting":"Untreated HLA-A*02:01-positive metastatic uveal melanoma: tebentafusp vs investigator's choice (pembrolizumab, ipilimumab, or dacarbazine)","sponsor":"Immunocore","result":"OS 21.7 vs 16.0 months; HR 0.51.","started":"2017-10-16","startedType":"actual","yearReported":2021,"enrolled":378,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Tebentafusp","value":21.7},{"name":"Investigator's choice","value":16}],"hr":0.51,"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2103485"}],"replication":"Supported by a phase 2 in previously treated uveal melanoma; no second randomised trial."},"route":"/trials/imcgp100-202/","neighbours":{"cancer":[{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"}],"technology":[{"id":"t-cell-engager","kind":"technology","name":"T-cell engagers (bispecific)","route":"/technologies/t-cell-engager/"}],"target":[{"id":"cd3","kind":"target","name":"CD3","route":"/targets/cd3/"},{"id":"gp100","kind":"target","name":"gp100 (PMEL)","route":"/targets/gp100/"}],"drug":[{"id":"tebentafusp","kind":"drug","name":"Tebentafusp","route":"/drugs/tebentafusp/"}],"company":[{"id":"immunocore","kind":"company","name":"Immunocore","route":"/companies/immunocore/"}],"person":[{"id":"paul-nathan","kind":"person","name":"Paul Nathan","route":"/people/paul-nathan/"},{"id":"richard-carvajal","kind":"person","name":"Richard D. Carvajal","route":"/people/richard-carvajal/"}],"paper":[{"id":"paper-imcgp100-202-n-engl-j-med-2021","kind":"paper","name":"Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma","route":"/key-papers/paper-imcgp100-202-n-engl-j-med-2021/"},{"id":"paper-imcgp100-202-n-engl-j-med-2023-update","kind":"paper","name":"Three-Year Overall Survival with Tebentafusp in Metastatic Uveal Melanoma","route":"/key-papers/paper-imcgp100-202-n-engl-j-med-2023-update/"}],"trial":[{"id":"nct02678572","kind":"trial","name":"FOCUS","route":"/trials/nct02678572/"}]}}