Symptoms and General Pathology

All Conditions

Immune System Diseases

Inflammation

Autoimmune Diseases

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Pembrolizumab

Atezolizumab

Immune Checkpoint Inhibitors

Avelumab

Durvalumab

Cemiplimab

Ipilimumab

Marie Hudson, MD

Manuel Flores, PhD

Marie Hudson, MD MPH

Immune checkpoint inhibitors (ICI) are among the most promising approaches to fighting cancer. However, a substantial percentage of patients experience off-target adverse effects in the form of mild to severe inflammation in different organs, commonly called immune-related adverse events (irAEs). irAEs can lead to treatment discontinuation, or can be life-threatening in extreme cases. The causes of irAEs are largely unknown and there are no reliable predictive biomarkers. The Montreal Immune-Related Adverse Events (MIRAE) study collects clinical information and biospecimens (blood, tissue, stool) from cancer patients treated with ICI to facilitate research on the identification of predictive biomarkers of irAEs, their causes, and the design of effective management strategies.

Background:

During cancer development and progression, cancer cells evolve to evade natural anti-tumor immunity. One major pathway of immune evasion involves the engagement of co-inhibitory receptors present on the surface of T cells that modulate their activation status, and therefore their ability to directly or indirectly kill tumor cells. These receptors are known as immune checkpoint inhibitors (ICI). Blockade of ICI using antibodies leads to prolonged T cell activation and unleashes the anti-tumor activity of T cells. ICI treatment for cancer has led to unprecedented advances in cancer treatment by prolonging survival of patients with previously refractory cancers. Among these ICI, CTLA-4, PD-1 and PDL-1 inhibitors have been shown to be effective cancer immunotherapies, and many other ICIs are now in pre-clinical and clinical development.

Although ICI cancer therapy is overall well tolerated, off-target immune reactions targeting healthy cells or tissues called immune-related adverse events (irAEs) develop in a substantial percentage of patients limiting the use of ICI therapy. irAEs target range from mild to severe and fatal. Currently, there are no reliable predictive biomarkers for the wide spectrum of irAEs and their clinical management in severe cases involves discontinuation of ICI therapy.

The Montreal Immune-Related Adverse Events (MIRAE) study is a biobank that collects human biological specimens (e.g., tissue, blood, plasma, PBMCs, saliva, stool) and the associated clinical information from cancer patients treated with ICI with the purpose of promoting research to identify clinical and biological predictors and mechanisms of irAEs, evaluate the effects of immunomodulatory treatment of irAEs on tumor biology, and investigate treatment strategies to minimize irAEs.

Objectives:

1. Identify biomarkers predictive of irAEs, including cellular, immunologic, genetic and microbial biomarkers; and
2. Evaluate the effects of immunomodulatory treatment of irAEs, and investigate treatment strategies that minimize irAEs and maximize ICI efficacy.

* Whole blood
* Peripheral blood mononuclear cells
* Stool
* Tissue biopsies

Montreal Immune-Related Adverse Events (MIRAE) Study

Montreal Database and Biorepository of Cancer Patients Treated With Immune Checkpoint Inhibitors for the Study of Immune-related Adverse Events

Sir Mortimer B. Davis - Jewish General Hospital

Marie Hudson, MD MPH FRCPC Principal Investigator, Rheumatologist, Division of Rheumatology and Department of Medicine, Jewish General Hospital and McGill University

Neoplasms

Blood and Lymph Conditions

Behaviors and Mental Disorders

Hematologic Neoplasms

Hematologic Diseases

Quality of Life

Immunomodulating Agents

Any immunotherapy by immune checkpoint inhibitor molecule in combination or monotherapy, associated or no with any other cancer treatment such as chemotherapy, targeted therapy, radiotherapy, etc.

Transplantation of recombined autologous immune T-cells

Assesment of the QoL \& irAEs determinants in patients diagnosed with solid tumor and treated in France, Netherlands, Portugal, Spain, with immunotherapy by immune checkpoint inhibitors.

QoL & irAEs determinants

Assesment of the QoL \& irAEs determinants in patients diagnosed with hematologic cancer and treated in France, Netherlands, Portugal, Spain, by CAR-T cells.

Delphine MAUCORT-BOULCH, PhD

Aurore FOUDA ESONGUE, PhD

Stephane DALLE, MD

MJ KERSTEN, MD

GH DE BOCK

M Gomes da Silva, MD

S Puig, MD

An increasing number of cancer patients are eligible to receive immunotherapy. Efficacy and tolerance have been demonstrated in multicentre randomized clinical trials with positive results. However, real-life experience differs from clinical trial results, especially regarding the management of potential adverse events. HR-QoL (Health Related Quality of Life) is one of the components of QoL (Quality of Life) in its broad acceptation and is certainly the only one usually collected in trials while little is known about QoL in cancer patients treated in the 'real-world'. QUALITOP partners intend to bring together all relevant longitudinal information present in large heterogeneous data (big data) to estimate patient QoL and find surrogate markers of QoL and its evolution. Within the QUALITOP consortium, 5 countries will collect prospective clinical and QoL data and also retrospective clinical data, and share it. This project will enable collecting, managing, sharing, modelling, processing, and exploiting big data on QoL. Furthermore, beyond the description of QoL, analytical tools (including causal inference methods and machine learning) are needed to understand the determinants of QoL and their complex relationships with irAEs (immune related Adverse Events) in a big-data context where standard statistical techniques would be limited. Artificial intelligence and causal models may be applied and developed to empower the patient, prevent adverse medical conditions, and promote QoL. The created knowledge will enable proposing guidelines for promoting better QoL.

QUALITOP aims at identifying the determinants of health status regarding immunotherapy-related adverse events (IR-AEs, such as toxicities) depending on the patient's profile in a real-world context.

The richness of QUALITOP is in the diversity of the experts who will collaborate in it. Clinicians involved in the care (thus the health status of the patients) will collaborate with psychologists and sociologists to understand and integrate complementary dimensions of QoL related to immunotherapy. Experts in pharmacovigilance and pharmacists will investigate the IR-AEs and their associations with patient behaviour and non-drug consumption. Epidemiologists, data scientists (including bioinformaticians and biostatisticians) and economists will extract information from the data and develop simulation models to produce knowledge. The project will take place in close relation with patient associations that will interact with experts to design the analyses, interpret their results, and proceed to their dissemination.

The main objective is to collect data of patients receiving immunotherapy in order to describe its impact in their quality of life.

* Create the first real-life cohort of cancer patients treated with immunotherapy within a context of multidimensional management (with data on clinical information, health-related QoL (HR-QoL), IR-AEs, drug consumption, lifestyle, and administrative data).
* Accelerate knowledge directed to different stakeholders (patients, relatives, clinicians, pharmacists, health authorities, and the general public) for a better understanding of the determinants of QoL and its optimization after immunotherapy through the development of innovative analytic tools (artificial intelligence and causal models).
* Produce policies and recommendations to improve patients QoL and participate in the implementation of the SDGs (Sustainable Development Goals) for 4P medicine (Predictive, Preventive, Personalized, Participative) in immunotherapy for cancer patients.

QUALITOP - Monitoring Multidimensional Aspects of QUAlity of Life After Cancer ImmunoTherapy, an Open Smart Digital Platform for Personalized Prevention and Patient Management

Monitoring Multidimensional Aspects of QUAlity of Life After Cancer ImmunoTherapy, an Open Smart Digital Platform for Personalized Prevention and Patient Management - QUALITOP -

Descriptive analysis of QoL determinants (which are there ? what are their impacts ? etc) based on collected data from the beginning of the treatment to 2 years.

Hospices Civils de Lyon

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Montreal Immune-Related Adverse Events (MIRAE) Study	NCT05139706	Cancer Immune System D... Inflammatory Re... Autoimmune Dise...		18 Years - 100 Years	Sir Mortimer B. Davis - Jewish General Hospital
QUALITOP - Monitoring Multidimensional Aspects of QUAlity of Life After Cancer ImmunoTherapy, an Open Smart Digital Platform for Personalized Prevention and Patient Management	NCT05626764	Solid Tumor Hematologic Can...	QoL & irAEs det... QoL & irAEs det...	18 Years -	Hospices Civils de Lyon
Montreal Immune-Related Adverse Events (MIRAE) Study	NCT05139706	Cancer Immune System D... Inflammatory Re... Autoimmune Dise...		18 Years - 100 Years	Sir Mortimer B. Davis - Jewish General Hospital

Spots Global Cancer Trial Database for iraes

Every month we try and update this database with for iraes cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for iraes

Every month we try and update this database with for iraes cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for iraes cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.