PRISM-MEL-301
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.
Phase 3 launched 2024. Supporting phase 1/2 data (ASCO 2026): in 66 heavily pretreated patients on monotherapy, median OS 14.3 months with 57% alive at 12 months; the 160 µg dose was carried into phase 3. PRAME is expressed in most cutaneous melanomas, giving a broader target than gp100.
Setting
Untreated HLA-A*02:01-positive advanced cutaneous melanoma: brenetafusp + nivolumab vs nivolumab-based regimens
Phase
Phase 3
Sponsor
Immunocore
Registry