Immune Related-adverse Events in Patients Receiving Immune Checkpoint Inhibitors
ICI-DISCOVER
Incidence, Clinical Management and Molecular Factors Associated With the Development of Immune-related Adverse Events in Cancer Patients Receiving PD-1 and PD-L1 Inhibitors: a Prospective Observational Study
1 other identifier
observational
200
1 country
1
Brief Summary
The recent introduction of anti-PD-1 (nivolumab and pembrolizumab) and anti- PD-L1 (atezolizumab, durvalumab, avelumab) immune checkpoint inhibitors revolutionized oncological guidelines. Durable responses and prolongation of survival with these agents come at the price of the development of immune related adverse events (irAEs). Innovative tools are required in order to manage irAEs and to prevent their potential relapse, with the goal to improve the outcome of patients. In this regard, the Investigators aim to develop a multidisciplinary clinical pathway for cancer patients that are treated with immune checkpoint inhibitors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 10, 2020
CompletedFirst Posted
Study publicly available on registry
February 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedFebruary 17, 2020
February 1, 2020
2 years
February 10, 2020
February 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Incidence of irAEs
To determine the incidence and the characteristics of irAEs in a real-world setting
24 months
Risk factors for irAEs
To determine the risk factors for the development of irAEs
24 months
Impact of irAEs
To determine the impact of irAEs on patients' prognosis
24 months
Therapies of irAEs
To determine the effect of immunosuppressive therapies on tumor progression and patient's prognosis
24 months
Secondary Outcomes (4)
Clinical care pathway
24 months
Quality of life
24 months
Biomarkers
24 months
Exploratory analyses
24 months
Eligibility Criteria
Patients referring to the Oncology and Hematology Clinics of the Azienda Ospedaliero- Universitaria Ospedali Riuniti di Ancona (Italy) may be enrolled.
You may qualify if:
- Adult patients above 18 years of age;
- Cyto-histological diagnosis of one of the following cancers:
- advanced melanoma;
- metastatic or locally advanced non-small cell lung cancer;
- advanced renal cell carcinoma;
- metastatic or locally advanced urotelial carcinoma;
- squamous cell carcinoma of the head and neck;
- Hodgkin lymphoma;
- Merkel-cell carcinoma;
- New prescription of one of the following PD-1/PD-L1 inhibitors:
- nivolumab
- pembrolizumab
- atezolizumab
- avelumab
- durvalumab alone or in combination therapy, following the indications of the Italian regulatory agency (AIFA).
You may not qualify if:
- Patients that refuse and/or are not able to sign the Informed Consent;
- Parents/guardians or subjects who, in the opinion of the Investigator, may be noncompliant with study schedules or procedures;
- No contraindications to the treatment with PD-1/PD-L1 antibodies, following the indications of the Italian regulatory agency (AIFA).
- Subjects that do not meet all of the enrollment criteria may not be enrolled.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Università Politecnica delle Marche
Ancona, AN, 60020, Italy
Related Publications (1)
Brahmer JR, Lacchetti C, Schneider BJ, Atkins MB, Brassil KJ, Caterino JM, Chau I, Ernstoff MS, Gardner JM, Ginex P, Hallmeyer S, Holter Chakrabarty J, Leighl NB, Mammen JS, McDermott DF, Naing A, Nastoupil LJ, Phillips T, Porter LD, Puzanov I, Reichner CA, Santomasso BD, Seigel C, Spira A, Suarez-Almazor ME, Wang Y, Weber JS, Wolchok JD, Thompson JA; National Comprehensive Cancer Network. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2018 Jun 10;36(17):1714-1768. doi: 10.1200/JCO.2017.77.6385. Epub 2018 Feb 14.
PMID: 29442540BACKGROUND
Biospecimen
Whole blood samples will be collected for the preparation of serum and plasma at the baseline visit and at follow-up visits for all patients.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor
Study Record Dates
First Submitted
February 10, 2020
First Posted
February 13, 2020
Study Start
January 1, 2019
Primary Completion
January 1, 2021
Study Completion
January 1, 2022
Last Updated
February 17, 2020
Record last verified: 2020-02