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Predictive Markers of Immune-related Adverse Events in Patients Treated With Immune Stimulatory Drugs
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1240
Start Date
2018-12-12
Completion Date
2028-12-11
Last Updated
2025-06-26
Healthy Volunteers
No
Conditions
Interventions
Blood sample
Blood (plasma+serum+PBMC) collection before the start of immunotherapy, at week 6 and upon grade ≥2 irAE.
Locations (5)
Gustave Roussy
Villejuif, Val De Marne, France
Gustave Roussy
Chevilly-Larue, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
Hôpital Marie Lannelongue
Le Plessis-Robinson, France
Hôpital Paul Brousse
Villejuif, France