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

NCT ID: NCT03984318

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-12
• Study Completion Date: 2028-12-11

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patient treated with immune checkpoint targeted monoclonal AB

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

Group Type: EXPERIMENTAL

Blood sample

Intervention Type: PROCEDURE

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

Interventions

Blood sample

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

France

Other Identifiers

2018/2728

Identifier Type: OTHER

Identifier Source: secondary_id

2018-A01257-48

Identifier Type: -

Identifier Source: org_study_id