ICEMELT

PROTOCOL TITLE

Risk factors of Immune – ChEckpoint inhibitors MEdiated Liver, gastrointestinal, endocrine and skin Toxicity (ICEMELT).

PURPOSE OF STUDY

Immunotherapy is a major breakthrough in clinical oncology. Despite it being a highly promising method for treating cancers, up to one half of all patients treated with immunotherapy will experience side effects. These events negatively affect patient’s well-being and commonly force oncologists to stop treatment.

Oncologists and researchers still do not understand the risk factors that contribute to toxicity development in cancer patients treated with immunotherapy. Thus, it is of particular importance to conduct specifically designed clinical studies in order to elucidate the mechanism of immunotherapy-related toxicity.

The study will investigate the changes to peripheral blood in patients receiving immunotherapy. If abnormally expressed proteins in the blood and/or tissue cells correlates with the development of treatment-related side effects, then further analysis will be conducted to understand the molecular mechanisms that lie beyond this significant association. Results gained may help to tailor treatment guidelines and allow oncologists to predict and prevent the development of undesirable treatment related side effects in cancer patients treated with immunotherapy.

ELIGIBILITY CRITERIA

Inclusion criteria
• Able to comprehend the requirements and procedures for the study and to provide informed consent before entering the study
• Solid malignant tumour
• Plan to receive ICI(immune checkpoint inhibitors)-based therapeutic regimens

Exclusion criteria
• Inability to give written informed consent
• Patients with a cognitive impairment, an intellectual disability or a mental condition that will interfere with the patient’s ability to understand the requirements of the study

CONTACT EMAIL

Dmitri.Shek@health.nsw.gov.au

STUDY CHAIRS

Professor Golo Ahlenstiel
Dr Bo Gao
Associate Professor Adnan Nagrial

DETAILED INFORMATION AVAILABLE

More detailed information available online at ClinicalTrials.gov please click here.

FUNDING

Professor Golo Ahlenstiel
Bristol Myers Squibb