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

Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03984318
Study type Interventional
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact Aurélien Marabelle, MD
Phone +33 (0)1 42 11 42 96
Email aurelien.marabelle@gustaveroussy.fr
Status Recruiting
Phase N/A
Start date December 12, 2018
Completion date December 11, 2028
View Details
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