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

Cancer Clinical Trial

— PREMIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03984318
• Other study ID #: 2018-A01257-48
• Secondary ID: 2018/2728
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2018
• Est. completion date: December 11, 2028

Study information

• Verified date: May 2022
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Aurélien Marabelle, MD
• Phone: +33 (0)1 42 11 42 96
• Email: aurelien.marabelle[@]gustaveroussy.fr
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1240
• Est. completion date: December 11, 2028
• Est. primary completion date: December 11, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Immune-related Adverse Events (irAE)		up to 5 years