Understanding and Anticipating Therapeutic and ADverse Responses in Anti-cancer Immune Checkpoint Inhibition Towards a Better Therapeutic Management of Patients

Summary

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.

Eligibility

* 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

  * Absolute neutrophil count ≥ 1500/µL or 1.5x109/L
  * Hemoglobin ≥ 9 g/dL
  * Platelets ≥ 100000/µL or 100x109/L
* Adequate liver function as defined below

  * Serum total bilirubin ≤ 1.5 x ULN. In case of known Gilbert's syndrome \< 3xUNL is allowed
  * AST (SGOT)/ALT (SGPT) ≤ 3.0 x ULN
  * Alkaline phosphatase ≤ 3.3 x ULN
* Adequate renal function as defined below

  \_- Creatinine ≤ 1.5 x UNL or creatinine clearance \> 60 mL/min
* Patient monitored for their cancer at CHU of Brest
* Did not oppose for their samples and clinical data to be used for translational research
* Non-opposition form obtained prior to any study related procedure

Exclusion Criteria:

* 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
* Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection)
* Subject of guardianship (tutorship, curatorship)
* Active pregnancy

Conditions1

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