CURRENT PROJECT 2
Immune-Tox: A prospective observational study of chronic and late adverse effects from immune checkpoint inhibitors in patients with melanoma
Clinical Investigators
Dr Rebecca Lee, Senior clinical lecturer medical oncology and Wellcome early career fellow, University of Manchester/The Francis Crick/University College London
Co-Investigators
Professor Paul Lorigan, Consultant Medical Oncologist in Melanoma and Professor of Cancer Cell biology, University of Manchester
Dr Ann Tivey, NIHR Academic Clinical Fellow (Medical Oncology)
Dr Safwan Adam, Consultant Endocrinologist (with a special interest in cardiovascular disease risk)
Professor Christopher Miller, Professor of Cardiovascular Medicine, NIHR Advanced Fellow and Honorary Consultant Cardiologist, University of Manchester
Dr James Tollitt, Consultant Renal Physician/Honorary Senior Lecturer in Cardiovascular Sciences
Dr Alexander Oldroyd, NIHR Academic Clinical Lecturer (Rheumatologist), University of Manchester
Dr Fabio Gomes, Consultant Medical Oncologist with special interest in Oncogeriatrics
Dr Cassandra Ng, Consultant Oncogeriatrician, The Christie NHS Foundation Trust
Professor Arpana Verma, Clinical Professor of Public Health and Epidemiology, University of Manchester
Dr Hui Guo, senior lecturer in Biostatistics at the Centre for Biostatistics, University of Manchester.
Dr Tim Cooksley, Consultant in Acute Oncology, The Christie NHS Foundation Trust
Project start date
Q3 2023
Proposed project duration
6 years (3 years of Melanoma Focus funding)
Project Summary
Immune checkpoint inhibitors (ICIs) enhance the immune system’s ability to attack and kill cancer cells. This treatment has proved very effective and so there is a growing population of patients with melanoma expected to live for many years after treatment with ICIs. Evidence regarding long-term effects of these treatments is limited.
The Immune-Tox study will look at long-term effects from ICIs in patients with melanoma. Patients who received adjuvant treatment with an ICI, i.e., after having had their melanoma surgically removed, will be recruited to the study. The patients will be monitored for several years, and they will be compared to patients who did not receive ICIs to look at any difference in any medical conditions, particularly cardiac, as well as looking at their quality of life and energy/tiredness levels. This information will allow doctors and patients to discuss the risks and benefits of ICIs before the treatment is started, it will also allow for better monitoring, prevention and management of side effects that may appear later on after treatment.
The main aims of the research project:
The main aim of the project is to look at the long-term side effects of adjuvant immune-check point inhibitor treatment in melanoma patients and compare them to patients who did not receive treatment. Knowing how these long-term side effects can affect patients will allow more informed decision making when prescribing adjuvant ICI treatment and potentially improve long-term quality of life of patients with melanoma.
The funding from Melanoma Focus is to be able to:
Set up the study, including recruiting personnel and setting up the database where the information will be stored. The funding will support the first 3 years of the running of the study which after set-up will cover recruiting patients and preliminary data collection.
NIHR badging will also be sought using the Melanoma Focus funding.
There is a commitment to collaborate on late-effects of immunotherapy research with the Melanoma Focus funded project LATENT (see below).
Comment from Clinical Investigators
“We are very grateful for the funding from Melanoma Focus for this study. It will provide the information we need to ensure that patients with melanoma have the best possible management throughout their cancer journey. It is important that we better understand the long-term impact of treatment so we can tailor our follow up management to improve outcomes for patients.”