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

Launched by UNIVERSITY HOSPITAL, BREST · Aug 1, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how certain blood markers can help predict side effects in cancer patients who are being treated with immune checkpoint inhibitors (ICIs). ICIs are a type of treatment that helps the immune system fight cancer, and sometimes patients may experience unwanted reactions, known as immune-related adverse events (irAEs). By collecting blood samples and data from patients during their regular follow-ups, researchers hope to better understand these reactions and improve treatment management for future patients.

To be eligible for the study, participants must be at least 18 years old, have a confirmed cancer diagnosis, and be eligible for ICI treatment, either alone or alongside other therapies like chemotherapy or radiation. Patients should also have good overall health, with adequate blood, liver, and kidney function. Participants will have their blood drawn and be monitored over time, but will not receive any new treatments or change their current care as part of this study. Importantly, patients will need to agree to the use of their health information and blood samples for research purposes.

Gender

ALL

Eligibility criteria

• • 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