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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

December 15, 2020

Primary Completion Date

December 10, 2024

Study Completion Date

December 10, 2025

Conditions
Lung Cancer, Nonsmall CellRenal Cell CarcinomaMelanomaGastric CancerHepatocellular CarcinomaEndometrial CancerMesothelioma
Interventions
DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

Trial Locations (2)

2145

RECRUITING

Westmead Hospital, Sydney

2148

RECRUITING

Blacktown Mt Druitt Hospital, Sydney

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of Western Sydney

OTHER

collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Western Sydney Local Health District

OTHER

NCT04631731 - Risk Factors of Immune-ChEckpoint Inhibitors MEdiated Liver, Gastrointestinal, Endocrine and Skin Toxicity | Biotech Hunter | Biotech Hunter