Risk Factors of Immune-ChEckpoint Inhibitors MEdiated Liver Gastrointestinal Endocrine and Skin Toxicity

  • End date
    Nov 9, 2025
  • participants needed
  • sponsor
    Western Sydney Local Health District
Updated on 12 November 2021
growth factor
kinase inhibitor
chemotherapy regimen
cancer chemotherapy
growth factors
platinum-based chemotherapy
formalin-fixed paraffin-embedded


"Risk factors of Immune-ChEckpoint inhibitor MEdiated Liver, gastrointestinal, endocrine and skin Toxicity" (ICEMELT) study is a prospective multicenter cohort study, enrolling patients who are scheduled to receive (1) single agent PD1/L1 inhibitor; (2) PD1/L1 inhibitor plus CTLA4 inhibitor; (3) platinum-based chemotherapy + PD1/L1 inhibitor; (4) PD1/L1 inhibitor and tyrosine kinase inhibitor and (5) PD1/L1 inhibitor and vascular endothelial growth factor (VEGF) inhibitor.


This project is based on strong multidisciplinary collaboration between oncologists, gastroenterologists/hepatologists, immunologists and basic scientists affiliated with (1) Western Sydney University, (2) University of Sydney, (3) Western Sydney Local Health District (4) New South Wales Health Pathology, (5) Westmead Institute for Medical Research.

Recruitment sites:

  • Blacktown Mt Druitt Hospital.
  • Westmead Hospital.

Research samples collection, processing and storage:

  • Blacktown Clinical School, Western Sydney University.
  • Westmead Institute for Medical Research, the University of Sydney.
  • New South Wales Health Pathology.

Potential patients will be identified by study investigators at Oncology clinics. After informed consent, clinicopathological data including patients' demographics, past medical history, cancer staging, relevant anticancer treatment, response/progression and survival will be collected longitudinally.

The following specimens will be collected from all participating patients at baseline (pre-treatment stage):

  • Peripheral blood (3 x 10mL EDTA tubes)
  • FibroScan (CAP score for elucidating pre-existing liver fibrosis)
  • Formalin-Fixed Paraffin-Embedded (FFPE) samples (one block) from core biopsies which is a part of routine care for cancer patients.

The following specimens will be collected after IPI + NIVO therapeutic regimen will be commenced (week 6-9 after ICI-therapy commencement):

Peripheral blood (3 x 10mL EDTA tubes)

Upon development of potential grade 2 irAEs, the following samples will be collected:

  • Peripheral blood (3 x 10mL EDTA tubes)
  • FibroScan (for patients with hepatic irAEs)
  • Tissue samples (if biopsies are collected as per standard of care for patients with immune-mediated colitis who will be required to undergo colonoscopy)

Peripheral blood samples from patients will be collected using 10ml EDTA vacutainer tubes (x3) and processed within 12 hours of collection by research staff at each site. Plasma will be used for miRNA assay. PBMCs will be split into 5 cryotubes and used for flow cytometry phenotyping of T cells (1 tube) and RNA/DNA profiling (2 tubes).

Consent to the study will allow researchers to access the baseline archive diagnostic FFPE tissue samples. With implementing cutting-edge spatial analysis tool we aim to define tissue heterogeneity in tumor samples regarding cancer immune cell transcriptional profiles and correlate it with the expression of specific coding/non-coding RNAs in ICI-treated cancer patients.

Fresh tissue samples obtained from patients with severe immune-mediated colitis during the colonoscopy or liver biopsy will be processed to obtain total RNA and immune cells for RNA sequencing and mass spectrometry (CyTOF).

Condition Malignant Melanoma, Renal Cell Carcinoma, liver cell carcinoma, Gastropathy, Stomach Discomfort, Renal Cancer, Endometrial Carcinoma, Skin Cancer, Gastric Carcinoma, Mesothelioma, Gastric Cancer, melanoma, Melanoma, Metastatic Melanoma, skin cancer, Lung Cancer Stage IV, HEPATIC NEOPLASM, Uterine Cancer, gastric cancers, Malignant Mesothelioma, Lung Cancer Stage III, Endometrial Cancer, Stomach Cancer, Renal Cell Cancer, HEPATOCELLULAR CARCINOMA, Malignant Adenoma, Liver Cancer, Adenocarcinoma, Non-Small Cell Lung Cancer, clear cell renal cell carcinoma, Malignant neoplasm of kidney, Kidney Cancer
Treatment Blood screening, Blood screening, Tissue screening
Clinical Study IdentifierNCT04631731
SponsorWestern Sydney Local Health District
Last Modified on12 November 2021


Yes No Not Sure

Inclusion Criteria

Able to comprehend the requirements and procedures for the study and to provide informed consent before entering the study
Solid malignant tumour (stage III-IV)
Treated with ICI-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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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