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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04631731




Registration number
NCT04631731
Ethics application status
Date submitted
10/11/2020
Date registered
17/11/2020
Date last updated
1/06/2023

Titles & IDs
Public title
Risk Factors of Immune-ChEckpoint Inhibitors MEdiated Liver, Gastrointestinal, Endocrine and Skin Toxicity
Scientific title
Risk Factors of Immune-ChEckpoint Inhibitors MEdiated Liver, Gastrointestinal, Endocrine and Skin Toxicity
Secondary ID [1] 0 0
2020/PID02542
Universal Trial Number (UTN)
Trial acronym
ICEMELT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer, Nonsmall Cell 0 0
Renal Cell Carcinoma 0 0
Melanoma 0 0
Gastric Cancer 0 0
Hepatocellular Carcinoma 0 0
Endometrial Cancer 0 0
Mesothelioma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Differentially expressed genes in circulating immune cells between patients with and without irAEs.
Timepoint [1] 0 0
Week 0-48
Primary outcome [2] 0 0
Expression of TIM-3, LAG3, VISTA and other inhibitory checkpoint molecules on tumour-infiltrating T cells.
Timepoint [2] 0 0
Week 0-48
Secondary outcome [1] 0 0
Association of pre-treatment BMI, neutrophil-to-lymphocyte ratio and other clinical parameters with irAEs.
Timepoint [1] 0 0
Week 0-48

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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/12/2025
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment hospital [2] 0 0
Blacktown Mt Druitt Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2145 - Sydney
Recruitment postcode(s) [2] 0 0
2148 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Western Sydney Local Health District
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Western Sydney
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Bristol-Myers Squibb
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04631731
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.
Public notes

Contacts
Principal investigator
Name 0 0
Golo Ahlenstiel, Professor
Address 0 0
Western Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dmitrii Shek, Dr
Address 0 0
Country 0 0
Phone 0 0
+61 412 035 533
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04631731