# PRISM-MEL-301

Source: https://onco.cc/trials/prism-mel-301/  
OnCo record `prism-mel-301` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-07
- Registry id: NCT06112314
- Phase: 3
- Setting: Untreated HLA-A*02:01-positive advanced cutaneous melanoma: brenetafusp + nivolumab vs nivolumab-based regimens
- Sponsor: Immunocore

## Sources

- ClinicalTrials.gov NCT06112314: https://clinicaltrials.gov/study/NCT06112314
- Immunocore ASCO 2026 update: 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

## Connected records

- cancers: [Advanced melanoma (unresectable stage III and stage IV)](https://onco.cc/cancers/advanced-melanoma/), [Melanoma](https://onco.cc/cancers/melanoma/)
- technologies: [T-cell engagers (bispecific)](https://onco.cc/technologies/t-cell-engager/)
- targets: [CD3](https://onco.cc/targets/cd3/), [PRAME](https://onco.cc/targets/prame/)
- drugs: [Brenetafusp](https://onco.cc/drugs/brenetafusp/), [Nivolumab](https://onco.cc/drugs/nivolumab/)
- companies: [Immunocore](https://onco.cc/companies/immunocore/)

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