About this trial
In the last decades, cancer treatment was based on surgery, radiotherapy and chemotherapy.
Recently, treatments have largely evolved, first with targeted therapies (notably tyrosin kinase inhibitors, TKI) and then with immune checkpoint inhibitors (ICPI, notably anti-CTLA-4 and anti- PD1). The last ones can induce durable anti-tumoral responses in patients, even if metastases are present. Their mechanisms of action are focused on the activation of immune system in order to eliminate the tumor. ICPI, because of their mechanisms of action, target immune tolerance key components and can induce important immune toxicities (colitis, hepatitis, dermatitis, thyroiditis ...), leading to early discontinuation of treatment, severe or chronic morbidity, and can sometimes be lethal. It is of importance to detect patient at risk of irAEs, because of the increasing use of ICPI and the long- term response capacity in treated patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patient with cancer, whatever initial tumoral histology and disease stage under ICPI treatment (anti-PD1 and/or anti-CTLA-4)
age > 18
followed in oncology, pneumology, dermatology, gastroenterology departments of Amiens-Picardie University Hospital or Saint Quentin hospital
who received verbal and written information, and signed the consent form for the study
Disqualifiers
non ICPI treated patients
patient who received a first line of ICPI treatment
patient who received or is receiving MEK inhibitors as a treatment (because of possible lower response to ICPI treatment when associated)
Trial design
Single group
Treatments tested in this trial
blood retriewal
Biological/Vaccineblood retriewal for cytokine concentration measurement
Treatment groups
Trial outcomes
Primary outcomes
Variation from baseline of IL6 concentration in riAEs patients
Variation from baseline of IL6 concentration (pG/mL) in riAEs patients
Variation from baseline of IL10 concentration in riAEs patients
Variation from baseline of IL10 concentration (pG/mL) in riAEs patients
Variation from baseline of IL15 concentration in riAEs patients
Variation from baseline of IL15 concentration (pG/mL) in riAEs patients
Variation from baseline of IL8 concentration in riAEs patients
Variation from baseline of IL8 concentration (pG/mL) in riAEs patients
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Hospitalier Universitaire, Amiens
Lead sponsor
Central Hospital Saint Quentin
Collaborator