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Clinical Trials in France / NCT03984318
Active, not recruiting Not applicable

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

NCT03984318 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2018-12-12
Last updated
2025-06-26

Condition(s) studied

Cancer

Investigational drug(s) / intervention(s)

Blood sample

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 * Patients with either liquid (hematological) or solid malignancy, in any line of treatment. * Patients treated with an immunotherapy based on immune checkpoint targeted monoclonal antibody (mainly anti-PD-1, anti-PD-L1, anti-CTLA-4 monotherapies and combinations) * Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol. * Patients must be affiliated to a social security system or beneficiary of the same * Patient able to read and write French * Women of child bearing potential must have a negative serum or urine β-HCG pregnancy test within 14 days prior to initiation of treatment * Sexually active women of childbearing potential must agree to use a highly effective method of birth control supplemented by a barrier method during the trial and for the duration planned in the SmPC or the study protocol after the last administration of each immunotherapy * Sexually active males patients must agree to use condom during the study and for the duration planned in the SmPC or the study protocol after the last administration of each immunotherapy. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception Exclusion Criteria: * Patients treated with immunotherapies that do not contain at least one immunomodulatory drug targeted against a co inhibitory checkpoint molecule * Known severe hypersensitivity reactions to monoclonal antibodies * Pregnant or breastfeeding women * Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Gustave Roussy Villejuif Val De Marne
Gustave Roussy Chevilly-Larue France
Hôpital Bicêtre Le Kremlin-Bicêtre France
Hôpital Marie Lannelongue Le Plessis-Robinson France
Hôpital Paul Brousse Villejuif France

More Gustave Roussy, Cancer Campus, Grand Paris trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03984318 on ClinicalTrials.gov ↗ ← All trials in France