Status:
RECRUITING
Understanding and Anticipating Therapeutic and ADverse Responses in Anti-cancer Immune Checkpoint Inhibition Towards a Better Therapeutic Management of Patients
Lead Sponsor:
University Hospital, Brest
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Brief 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) alon...
Detailed Description
Advances in treating patients with immunotherapy have dramatically changed cancer morbidity and mortality. Immune checkpoint inhibitors (ICI), alone or combined with other treatments, are currently us...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 9 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 9 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05973344
Start Date
February 9 2024
End Date
February 9 2029
Last Update
February 20 2024
Active Locations (1)
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1
Brest University Hospital
Brest, France, 29200