Actively Recruiting
Understanding and Anticipating Therapeutic and ADverse Responses in Anti-cancer Immune Checkpoint Inhibition Towards a Better Therapeutic Management of Patients
Led by University Hospital, Brest · Updated on 2026-02-04
200
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Understanding and Anticipating Therapeutic and ADverse Responses in Anti-cancer Immune Checkpoint Inhibition Towards a Better Therapeutic Management of Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 18 years old
- ECOG performance status 65 0 and 41 1
- Histologically or cytologically confirmed tumour eligible for treatment with immune checkpoint inhibitors alone or in combination with other therapies
- Adequate bone marrow function: neutrophils 65 1500/b5L, hemoglobin 65 9 g/dL, platelets 65 100000/b5L
- Adequate liver function: bilirubin 41 1.5 x ULN (or 41 3 x ULN if Gilbert's syndrome), AST/ALT 41 3.0 x ULN, alkaline phosphatase 41 3.3 x ULN
- Adequate renal function: creatinine 41 1.5 x ULN or creatinine clearance e 60 mL/min
- Monitored for cancer at CHU of Brest
- Did not oppose use of samples and clinical data for research
- Non-opposition form obtained before study procedures
You will not qualify if you...
- Significant uncontrolled medical, neuro-psychiatric, or surgical condition interfering with study completion
- Already receiving immune checkpoint inhibitor treatment
- Primary immunodeficiency or history of allogenic transplantation
- Current active infection
- Known HIV, Hepatitis B, or Hepatitis C infection (except chronic or cleared cases)
- Subject of guardianship (tutorship, curatorship)
- Active pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Brest University Hospital
Brest, France, 29200
Actively Recruiting
Research Team
B
Benjamin Auberger
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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