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

NCT05813418 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-06-04

No results posted yet for this study

Summary

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.

Conditions

  • Immunotherapy
  • Immune Checkpoint Inhibitors
  • Immune-related Adverse Event
  • Predictive Biomarkers

Interventions

BIOLOGICAL

blood retriewal

blood retriewal for cytokine concentration measurement

Sponsors & Collaborators

  • Central Hospital Saint Quentin

    collaborator OTHER_GOV

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-02
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05813418 on ClinicalTrials.gov