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ACTIVE NOT RECRUITING
NCT03984318
NA

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

Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

View on ClinicalTrials.gov

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

PROCEDURE

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