Aim The general aim of this study is to determine the genetic and cellular bases of susceptibility to autoimmune adverse effects in patients receiving immune checkpoint inhibitors (ICIs).
Objectives The specific objectives are to determine:
Methods Additional biospecimens and data are being collected in 6 investigator-initiated, multicentre clinical trials of ICIs, and 1 single-site observational study.
Included trials spanning multiple tumour types: endometrial cancer (PHAEDRA), renal cell cancer (KEYPAD), mesothelioma (DREAM), non-small-cell lung cancer (NIVORAD, ILLUMINATE), glioblastoma multiforme (NUTMEG), and mixed cancer types treated with ICI at Canberra Hospital (CH). Blood samples are shipped in real-time from sites to the central laboratory at Australian National University for isolation of peripheral blood mononuclear cells. Frozen whole blood and serum samples are also collected.
Study blood timepoints are at baseline, 4-12 weeks after commencing ICI, and at time of any IRAE.
Accrual since June 2017: DREAM: 35, PHAEDRA: 44, KEYPAD: 9, NIVORAD: 9, NUTMEG: 5, ILLUMINATE: 0, CH cohort: 18; for a total of 120 out of 300 planned participants (40%).