A Phase II Non-Randomized, Open-label, Multi-centre Study of the Safety and Efficacy of Tebentafusp in Melanoma With Molecular Relapsed Disease
Researchers are trying to find ways to improve the management of people with intermediate or high risk resected cutaneous melanoma or with primary uveal melanoma. This research study is investigating using a new blood test to decide when to give a drug called tebentafusp. Tebentafusp has been used in clinical trials in patients with advanced cutaneous and uveal melanoma. This study is designed to determine if tebentafusp can help patients with cutaneous or uveal melanoma live longer.
⁃ A patient will be eligible for inclusion in cohort A or B if all of the following criteria apply:
• Uveal or cutaneous melanoma with MRD detected in molecular screening, and repeat confirmation of MRD in the sample taken as part of screening for the main study.
• Written (signed and dated) informed consent.
• Male or female, Age 18 years and above.
• Life expectancy of at least 3 months.
• ECOG performance score of 0 or 1.
• No evidence of metastatic disease on a CT scan of neck/thorax/abdomen/pelvis for cohorts A and B and also on MRI liver for uveal melanoma for cohort B.
• Those receiving prior immunotherapy must have recovered from any immune-mediated adverse events (≤ grade 1) other than endocrinopathies on stable replacement therapy.
• Haematological and biochemical indices within normal ranges (refer to protocol for ranges)