Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients Undergoing Immune CheckPoint Inhibitors (ICPI) Treatment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • blood retriewal

    Biological/Vaccine

    blood retriewal for cytokine concentration measurement

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Variation from baseline of IL6 concentration in riAEs patients

Variation from baseline of IL6 concentration (pG/mL) in riAEs patients

Time frame
6 months
2

Variation from baseline of IL10 concentration in riAEs patients

Variation from baseline of IL10 concentration (pG/mL) in riAEs patients

Time frame
6 months
3

Variation from baseline of IL15 concentration in riAEs patients

Variation from baseline of IL15 concentration (pG/mL) in riAEs patients

Time frame
6 months
4

Variation from baseline of IL8 concentration in riAEs patients

Variation from baseline of IL8 concentration (pG/mL) in riAEs patients

Time frame
6 months

Secondary outcomes

Other outcomes

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