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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03984318
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : May 27, 2022
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer Procedure: Blood sample Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1240 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Predictive Markers of Immune-related Adverse Events in Patients Treated With Immune Stimulatory Drugs
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : December 11, 2026
Estimated Study Completion Date : December 11, 2028
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Procedure: Blood sample
Blood (plasma+serum+PBMC) collection before the start of immunotherapy, at week 6 and upon grade ≥2 irAE.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Immune-related Adverse Events (irAE) [ Time Frame: up to 5 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984318


Contacts
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Contact: Aurélien Marabelle, MD +33 (0)1 42 11 42 96 aurelien.marabelle@gustaveroussy.fr
Contact: Nathalie Chaput, MD +33 (0)1 42 11 56 55 nathalie.chaput@gustaveroussy.fr

Locations
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France
Gustave Roussy Recruiting
Villejuif, Val De Marne, France, 94805
Contact: François-Xavier DANLOS, MD    +33 (0)1 42 11 42 96    aurelien.marabelle@gustaveroussy.fr   
Gustave Roussy Recruiting
Chevilly-Larue, France, 94550
Contact: Meriem MOKDAD-ADI         
Hôpital Bicêtre Not yet recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: Olivier LAMBOTTE         
Hôpital Marie Lannelongue Not yet recruiting
Le Plessis-Robinson, France, 92350
Contact: Jérôme LE PAVEC         
Hôpital Paul Brousse Not yet recruiting
Villejuif, France, 94800
Contact: Eleonora DE MARTIN         
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
More Information
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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT03984318    
Other Study ID Numbers: 2018-A01257-48
2018/2728 ( Other Identifier: CSET number )
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: May 27, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No