Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination with Pembrolizumab Versus Investigator’s Choice in HLA-A*02:01-positive Participants with Previously Treated Advanced Melanoma (TEBE-AM)

PI: Dr. Michele Del Vecchio 

This is a phase 3, multicenter, open-label study to evaluate the efficacy and safety of tebentafusp as monotherapy (Arm A) and in combination with pembrolizumab (Arm B) compared with standard of care or best supportive care (Arm C) in participants with non-ocular advanced melanoma who have progressed on a prior anti-PD(L)1 regimen, received an approved anti-CTLA4 regimen and, if the participant has a BRAF mutation, a prior BRAF tyrosine kinase inhibitor (TKI) regimen. 

The principal object of the study is to demonstrate overall survival superiority of tebentafusp,  monotherapy or combination with pembrolizumab, versus Investigator’s Choice. 

Moreover, secondary objects are: 

• To understand the impact of the study treatments on the patient’s symptoms and quality of life through standard questionnaires; 
• To understand if a blood test called “Signatera” helps understand which patients respond to treatment and live longer. The Signatera test measures traces of the tumor in the blood and monitors any changes during treatment.