{"entity":{"id":"prism-mel-301","kind":"trial","name":"PRISM-MEL-301","aka":[],"tldr":"Tests whether a PRAME-directed T-cell engager adds to first-line immunotherapy in ordinary skin melanoma, following tebentafusp's success in the eye form.","summary":"PRISM-MEL-301, trial NCT06112314 sponsored by Immunocore, tests whether the PRAME-directed T-cell engager brenetafusp adds to first-line nivolumab-based immunotherapy in untreated HLA-A*02:01-positive advanced cutaneous melanoma, following tebentafusp's success in the eye form of the disease. The phase 3 launched in 2024, and supporting phase 1/2 data at ASCO 2026 in 66 heavily pretreated patients on monotherapy showed encouraging survival, with the 160 microgram dose carried into phase 3; PRAME is expressed in most cutaneous melanomas, giving a broader target than gp100. OnCo links it to T-cell engagers, PRAME and CD3 as targets, brenetafusp, nivolumab and Immunocore. It is recruiting with no results, and whether a soluble TCR bispecific can improve first-line outcomes in a common solid tumour is the question it exists to answer.","status":"recruiting","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT06112314","url":"https://clinicaltrials.gov/study/NCT06112314"},{"label":"Immunocore ASCO 2026 update","url":"https://www.globenewswire.com/news-release/2026/05/31/3303917/0/en/immunocore-presents-updated-phase-1-data-of-brenetafusp-in-patients-with-heavily-pretreated-advanced-melanoma.html"}],"tags":[],"related":[],"cancers":["melanoma"],"sections":[],"technologies":["t-cell-engager"],"targets":["prame","cd3"],"drugs":["brenetafusp","nivolumab"],"companies":["immunocore"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06112314","phase":"3","setting":"Untreated HLA-A*02:01-positive advanced cutaneous melanoma: brenetafusp + nivolumab vs nivolumab-based regimens","sponsor":"Immunocore","participation":[{"nct":"NCT06112314","source":"https://clinicaltrials.gov/study/NCT06112314","fetchedAt":"2026-10-07T16:54:14.819Z","studySha256":"2cacd4b8fe5ec515821d1aa782e1c9ba52f85f36939957cfeceefc7e14b74781","overallStatus":"RECRUITING","lastUpdatePosted":"2026-02-25","leadSponsor":"Immunocore Ltd","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":680,"enrolmentType":"ESTIMATED","siteCount":211,"recruitingSiteCount":201,"countries":["Argentina","Australia","Austria","Belgium","Brazil","Bulgaria","Canada","Czechia","Denmark","Finland","France","Germany","Hungary","Italy","Lithuania","Mexico","Norway","Poland","Portugal","Romania","Spain","Sweden","Switzerland","Turkey (Türkiye)","United Kingdom","United States"]}],"started":"2024-06-05","startedType":"actual","enrolledBasis":"registry","outcomes":[]},"route":"/trials/prism-mel-301/","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":"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":"prame","kind":"target","name":"PRAME","route":"/targets/prame/"}],"drug":[{"id":"brenetafusp","kind":"drug","name":"Brenetafusp","route":"/drugs/brenetafusp/"},{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"}],"company":[{"id":"immunocore","kind":"company","name":"Immunocore","route":"/companies/immunocore/"}]}}