NCT03984318

Predictive Markers of Immune-related Adverse Events in Patients Treated With Immune Stimulatory Drugs

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,240 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The prospect of effective immunotherapies for the treatment of patients with cancer is now a clinical reality thanks to the approval of monoclonal antibodies (mAbs) specifically blocking immune checkpoints or ligands such as CTLA-4, PD-1 and PD-L1. However, these drugs can also induce inflammatory and/or auto-immune complications (Immune-related Adverse Events; IrAE). IrAE can affect all tissues and sometimes irreversibly. IrAE may be severe or fatal in the absence of timely and adequate care with anti-inflammatory drugs (steroids) or more specific immunosuppressants. Thus, IrAE are a new type of toxicities in oncology and represent one of the major limitations for the development of immunotherapy combination therapies. These IrAE are yet unpredictable. Indeed, the induction of immunity relies on the host's immune status and it differs from one patient to another and so far nobody has identified the underlying mechanisms responsible for irAE outbreaks.

Conditions

• Cancer

Interventions

Type	Name	Description
PROCEDURE	Blood sample	Blood (plasma+serum+PBMC) collection before the start of immunotherapy, at week 6 and upon grade ≥2 irAE.

Timeline

• Start date: 2018-12-12
• Primary completion: 2026-12-11
• Completion: 2028-12-11
• First posted: 2019-06-13
• Last updated: 2025-06-26

Locations

5 sites across 1 country: France