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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.
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.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares Immunocore, Brenetafusp, T-cell engagers (bispecific).
Shares Immunocore, Advanced melanoma (unresectable stage III and stage IV), T-cell engagers (bispecific), Melanoma.
Shares PRAME, Advanced melanoma (unresectable stage III and stage IV), Melanoma.
Shares Advanced melanoma (unresectable stage III and stage IV), Nivolumab, Melanoma.
Shares Advanced melanoma (unresectable stage III and stage IV), Nivolumab, Melanoma.
Shares Brenetafusp, PRAME, T-cell engagers (bispecific), Melanoma.
Shares Advanced melanoma (unresectable stage III and stage IV), Nivolumab, Melanoma.
Shares Advanced melanoma (unresectable stage III and stage IV), Nivolumab, Melanoma.
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