Tebentafusp in MRD Melanoma
Research type
Research Study
Full title
A Phase II Non-Randomized, Open-label, Multi-centre Study of the Safety and Efficacy of Tebentafusp in Melanoma with Molecular Relapsed Disease Short title: Tebentafusp in MRD Melanoma
IRAS ID
1003674
Contact name
Mark Middleton
Contact email
Sponsor organisation
University of Oxford
Eudract number
2019-003946-36
Clinicaltrials.gov Identifier
Research summary
We 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.
For the pre-screening stage we aim to recruit approximately 850 participants from up to 50 hospitals across the UK. To help decide whether or not you can take part in this research study we need to check first if the patient's immune system can ‘see’ tebentafusp. People have differences in their immune systems (tissue types, a bit like blood groups) and the study treatment can only work with a particular tissue type called Human Leukocyte Antigen (HLA) A*0201. To be able to take part in this study participants need to be HLA A*0201 positive.
In the monitoring part of the trial, participants will have a blood test every three months for up to a year, as well as the usual follow up visits for their melanoma. If one of these tests shows traces of melanoma, then they may become eligible to receive tebentafusp.
During the drug administration phase participants will have weekly assessments to assess the effect of tebentafusp. Many of the assessments are part of normal care, but additional tests are performed, such as research blood samples. This part of the study consists of weekly visits for up to 6 months. After this, participants will be followed up in clinic every 3 months for a year (4 visits in total).REC name
South Central - Oxford A Research Ethics Committee
REC reference
22/SC/0092
Date of REC Opinion
27 May 2022
REC opinion
Further Information Favourable Opinion