Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04631731
Registration number
NCT04631731
Ethics application status
Date submitted
10/11/2020
Date registered
17/11/2020
Titles & IDs
Public title
Risk Factors of Immune-ChEckpoint Inhibitors MEdiated Liver, Gastrointestinal, Endocrine and Skin Toxicity
Query!
Scientific title
Risk Factors of Immune-ChEckpoint Inhibitors MEdiated Liver, Gastrointestinal, Endocrine and Skin Toxicity
Query!
Secondary ID [1]
0
0
2020/PID02542
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
ICEMELT
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Lung Cancer, Nonsmall Cell
0
0
Query!
Renal Cell Carcinoma
0
0
Query!
Melanoma
0
0
Query!
Gastric Cancer
0
0
Query!
Hepatocellular Carcinoma
0
0
Query!
Endometrial Cancer
0
0
Query!
Mesothelioma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Non melanoma skin cancer
Query!
Cancer
0
0
0
0
Query!
Kidney
Query!
Cancer
0
0
0
0
Query!
Womb (Uterine or endometrial cancer)
Query!
Cancer
0
0
0
0
Query!
Lung - Mesothelioma
Query!
Cancer
0
0
0
0
Query!
Lung - Non small cell
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Diagnosis / Prognosis - Blood screening
Diagnosis / Prognosis - Tissue screening
Experimental: Single agent PD-1/L1 inhibitor -
Experimental: PD-1/L1 inhibitor + CTLA-4 inhibitor -
Experimental: Platinum-based chemotherapy + PD-1/L1 inhibitor -
Experimental: PD-1/L1 inhibitor + tyrosine kinase inhibitor -
Experimental: PD-1/L1 inhibitor + VEGF inhibitor -
Diagnosis / Prognosis: Blood screening
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.
Diagnosis / Prognosis: Tissue screening
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.
Query!
Intervention code [1]
0
0
Diagnosis / Prognosis
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Differentially expressed genes in circulating immune cells between patients with and without irAEs.
Query!
Assessment method [1]
0
0
This objective will be achieved through single-cell sequencing.
Query!
Timepoint [1]
0
0
Week 0-48
Query!
Primary outcome [2]
0
0
Expression of TIM-3, LAG3, VISTA and other inhibitory checkpoint molecules on tumour-infiltrating T cells.
Query!
Assessment method [2]
0
0
In order to ascertain this result, our objective is to utilize spatial transcriptomics and mass spectrometry.
Query!
Timepoint [2]
0
0
Week 0-48
Query!
Secondary outcome [1]
0
0
Association of pre-treatment BMI, neutrophil-to-lymphocyte ratio and other clinical parameters with irAEs.
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Week 0-48
Query!
Eligibility
Key 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
Query!
Minimum age
No limit
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Diagnosis
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
15/12/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
10/12/2025
Query!
Actual
Query!
Sample size
Target
200
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
Westmead Hospital - Sydney
Query!
Recruitment hospital [2]
0
0
Blacktown Mt Druitt Hospital - Sydney
Query!
Recruitment postcode(s) [1]
0
0
2145 - Sydney
Query!
Recruitment postcode(s) [2]
0
0
2148 - Sydney
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Western Sydney Local Health District
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
University of Western Sydney
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Commercial sector/industry
Query!
Name [2]
0
0
Bristol-Myers Squibb
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04631731
Query!
Trial related presentations / publications
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. Shek 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. Shek 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. Shek 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Golo Ahlenstiel, Professor
Query!
Address
0
0
Western Sydney Local Health District
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Dmitrii Shek, Dr
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+61 412 035 533
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Shek D, Gloss B, Lai J, Ma L, Zhang HE, Carlino MS...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT04631731