Risk Factors of Immune-ChEckpoint Inhibitors MEdiated Liver, Gastrointestinal, Endocrine and Skin Toxicity
ICEMELT
1 other identifier
interventional
200
1 country
2
Brief Summary
"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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2020
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2020
CompletedFirst Posted
Study publicly available on registry
November 17, 2020
CompletedStudy Start
First participant enrolled
December 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2025
CompletedJune 1, 2023
May 1, 2023
4 years
November 10, 2020
May 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Differentially expressed genes in circulating immune cells between patients with and without irAEs.
This objective will be achieved through single-cell sequencing.
Week 0-48
Expression of TIM-3, LAG3, VISTA and other inhibitory checkpoint molecules on tumour-infiltrating T cells.
In order to ascertain this result, our objective is to utilize spatial transcriptomics and mass spectrometry.
Week 0-48
Secondary Outcomes (1)
Association of pre-treatment BMI, neutrophil-to-lymphocyte ratio and other clinical parameters with irAEs.
Week 0-48
Study Arms (5)
Single agent PD-1/L1 inhibitor
EXPERIMENTALPD-1/L1 inhibitor + CTLA-4 inhibitor
EXPERIMENTALPlatinum-based chemotherapy + PD-1/L1 inhibitor
EXPERIMENTALPD-1/L1 inhibitor + tyrosine kinase inhibitor
EXPERIMENTALPD-1/L1 inhibitor + VEGF inhibitor
EXPERIMENTALInterventions
Blood will be taken in order to elucidate transcriptomic and proteomic differences (1) pre- and post-ICI treatment commencement; (2) in patients with and without immune-related adverse events.
Archival tumor tissue (FFPE) will be spatially analysed in order to define tissue heterogeneity in tumor samples regarding cancer immune cell transcriptional profiles and correlate it with the occurrence/development of immune-related adverse events.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- Western Sydney Local Health Districtlead
- University of Western Sydneycollaborator
- Bristol-Myers Squibbcollaborator
Study Sites (2)
Westmead Hospital
Sydney, New South Wales, 2145, Australia
Blacktown Mt Druitt Hospital
Sydney, New South Wales, 2148, Australia
Related Publications (4)
Shek D, Read SA, Akhuba L, Qiao L, Gao B, Nagrial A, Carlino MS, Ahlenstiel G. Non-coding RNA and immune-checkpoint inhibitors: friends or foes? Immunotherapy. 2020 May;12(7):513-529. doi: 10.2217/imt-2019-0204. Epub 2020 May 7.
PMID: 32378480BACKGROUNDShek D, Read SA, Nagrial A, Carlino MS, Gao B, George J, Ahlenstiel G. Immune-Checkpoint Inhibitors for Advanced Hepatocellular Carcinoma: A Synopsis of Response Rates. Oncologist. 2021 Jul;26(7):e1216-e1225. doi: 10.1002/onco.13776. Epub 2021 Apr 21.
PMID: 33818870BACKGROUNDShek D, Akhuba L, Carlino MS, Nagrial A, Moujaber T, Read SA, Gao B, Ahlenstiel G. Immune-Checkpoint Inhibitors for Metastatic Colorectal Cancer: A Systematic Review of Clinical Outcomes. Cancers (Basel). 2021 Aug 27;13(17):4345. doi: 10.3390/cancers13174345.
PMID: 34503155BACKGROUNDShek D, Gloss B, Lai J, Ma L, Zhang HE, Carlino MS, Mahajan H, Nagrial A, Gao B, Read SA, Ahlenstiel G. Identification and Characterisation of Infiltrating Immune Cells in Malignant Pleural Mesothelioma Using Spatial Transcriptomics. Methods Protoc. 2023 Mar 28;6(2):35. doi: 10.3390/mps6020035.
PMID: 37104017RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Golo Ahlenstiel, Professor
Western Sydney Local Health District
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
November 10, 2020
First Posted
November 17, 2020
Study Start
December 15, 2020
Primary Completion
December 10, 2024
Study Completion
December 10, 2025
Last Updated
June 1, 2023
Record last verified: 2023-05