The goal of this observational study is to explore the value of blood biomarkers for the purpose of predicting irAE development in cancer patients treated with immune checkpoint inihibitors (ICI) alone or in combination with other treatments (chemotherapy, radiotherapy and targeted therapy).
Data and blood samples will be collected from participants at different time points as part of routine follow-up visits. Data and blood samples will be analysed. Analysis will include the characterization of immune cells by mass and flow cytometry.
Age ≥ 18 years old
ECOG performance status ≤ 1
Must have histologically or cytologically confirmed tumour, eligible for treatment with ICI as standard-of-care alone or in combination with another ICI, ICI with chemotherapy, ICI with radiotherapy, or ICI with targeted therapy with no restrictions on number of prior systemic therapies
Adequate bone marrow function as defined below
Patient with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study
Patient already receiving ICI
Primary immunodeficiency and/or history of allogenic transplantation
Current active infection
All patients with tumors treated with ICI (anti-CTLA-4, anti-PD-1/PD-L1, LAG3, etc.) as standard-of-care, alone or in combination with other treatments (chemotherapy, radiotherapy and targeted therapy)
Cohort
Prospective
Not listed
Occurrence of irAE over the duration of the patient's follow-up
Apparition of irAE is appreciated according the physician definition. The description and grading scales of irAE found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0. A copy of the CTCAE version 5.0 can be downloaded from the CTEP web site http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.
Survival (PFS).
PFS is defined as the time from random assignment in the clinical trial to disease progression or death from any cause.
Survival (OS).
OS is defined as the time from random assignment in the clinical trial to death.
Tumor response according to the iRECIST criteria
A copy of the iRECIST can be downloaded from the Lancet Oncology web site: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30074-8/fulltext
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