Phase 3 Trial Comparing Tebentafusp Alone or With Pembrolizumab to Investigators Choice in HLA-A*0201-Positive Patients With Previously Treated Advanced Non-Ocular Melanoma

What this Trial Is About

Researchers are evaluating the effectiveness and safety of tebentafusp-based treatments for patients with advanced non-ocular melanoma who have previously been treated. The study compares tebentafusp alone, tebentafusp combined with pembrolizumab, and the investigators choice of therapy, including other clinical trials or standard care options. This phase 3, open-label, multicenter trial focuses on patients who have progressed after previous immunotherapy and targeted treatments if applicable. Participants are randomly assigned to one of three groups tebentafusp alone, tebentafusp with pembrolizumab, or the investigators choice of therapy. The treatments are given according to protocol with ongoing evaluation. The study includes long-term follow-up of up to about four years to assess overall survival and other health outcomes. During the study, participants will undergo various assessments, including tumor evaluations, blood tests for circulating tumor DNA and drug levels, and quality of life questionnaires. Safety will be closely monitored by tracking adverse events and immune reactions. Study visits and evaluations will occur at designated time points over the treatment and follow-up periods to measure treatment impact and participant well-being.

Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)