ATOM (EORTC 2022-MG)
Research type
Research Study
Full title
Adjuvant tebentafusp (IMCgp100) versus observation in HLA-A*02:01 positive patients following definitive treatment of high-risk uveal melanoma: an EORTC randomized phase III study (ATOM Trial)
IRAS ID
1005922
Contact name
Lore Hermans
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer (EORTC)
Clinicaltrials.gov Identifier
Research summary
This study is about a new treatment for uveal melanoma patients. Melanoma of the eye, also called uveal melanoma, is a disease that behaves differently from melanoma of the skin (a type of skin cancer).
Despite complete removal of the cancer by surgery or radiation therapy, the risk of the melanoma coming back (a recurrence) in the future is approximately 50%. Currently, there is no scientifically proven treatment that is considered safe and that would help to reduce the risk of recurrence.
This study will investigate whether a new immunotherapy drug called tebentafusp can reduce the risk of recurrence. Tebentafusp is an experimental medication. It helps T cells (part of the body’s immune system) stick to and attack the cancer cells. One end of tebentafusp attaches to the cancer cells, the other end turns on the T cells.
Tebentafusp is already used to treat uveal melanoma which has spread beyond the eyes and has shown to help these patients live longer. Adult patients with uveal melanoma limited to the eye, treated with either radiotherapy or surgery, will be eligible to participate in this study. Patients included in this study are patients who would not normally receive further treatment in routine care.
The purpose of this study is to see whether tebentafusp will improve the chance that the disease does not return. Additionally, this study aims to find out whether tebentafusp prolongs the survival of patients without the disease worsening and survival in general and, also, to evaluate the impact in terms of side effects from the drug, quality of life and circulating substances (called biomarkers) in the blood.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
24/NW/0372
Date of REC Opinion
22 Jan 2025
REC opinion
Further Information Favourable Opinion