Risk Factors of Immune-ChEckpoint Inhibitors MEdiated Liver, Gastrointestinal, Endocrine and Skin Toxicity
Who is this study for? Patients with Lung Cancer, Renal Cell Carcinoma, Melanoma, Gastric Cancer, Hepatocellular Carcinoma
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Australia
Blacktown Mt Druitt Hospital
RECRUITING
Sydney
Westmead Hospital
RECRUITING
Sydney
Contact Information
Primary
Dmitrii Shek, Dr
Dmitri.Shek@health.nsw.gov.au
+61 412 035 533
Time Frame
Start Date: 2020-12-15
Estimated Completion Date: 2025-12-10
Participants
Target number of participants: 200
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Bristol-Myers Squibb, University of Western Sydney
Leads: Western Sydney Local Health District