Immunological Variables Associated to ICI Toxicity in Cancer Patients
Status:
Not yet recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
This is a monocentric, prospective, pilot study that will enrol 435 subjects with solid
tumours that are treated with immune checkpoint inhibitor(s) (ICI) alone or in combination
with chemotherapy or targeted therapy.
For enrolled subjects, clinical and laboratory evaluations will be performed and reported at
different time points:
- Early (4-6 weeks after treatment start)
- Midtime (8-11 weeks after treatment start)
- Late (13-18 weeks after treatment start)
- At the occurrence of immune-related adverse events (irAEs), clinical and laboratory
evaluation will be performed at two principal time points:
- For the 1st time of any grade 1 or 2 irAE if the subject developed it.
- For the 1st time of any grade 3 or 4 irAE if the subject developed it.