Study Design
This is an unblinded non-randomised, open labelled, safety and efficacy study involving 2 patient cohorts:
- A: Cutaneous melanoma with molecular relapsed disease (MRD)
- B: Uveal melanoma with MRD
Approximately 850 patients (600 cutaneous melanoma, 250 uveal melanoma) will be enrolled from 50 centres to screen for HLA-A*0201 status and then followed for up to 12 months for MRD at those same centres. Patients identified with MRD will be invited to be treated with tebentafusp at up to 10 treating centres in the UK. Patients will receive up to six months of tebentafusp, administered weekly IV, and then followed-up for one year for molecular and clinical relapse.
