Immune Related-adverse Events in Patients Receiving Immune Checkpoint Inhibitors

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.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

1. Adult patients above 18 years of age;
2. Cyto-histological diagnosis of one of the following cancers:

   1. advanced melanoma;
   2. metastatic or locally advanced non-small cell lung cancer;
   3. advanced renal cell carcinoma;
   4. metastatic or locally advanced urotelial carcinoma;
   5. squamous cell carcinoma of the head and neck;
   6. Hodgkin lymphoma;
   7. Merkel-cell carcinoma;
3. New prescription of one of the following PD-1/PD-L1 inhibitors:

   1. nivolumab
   2. pembrolizumab
   3. atezolizumab
   4. avelumab
   5. durvalumab alone or in combination therapy, following the indications of the Italian regulatory agency (AIFA).

Exclusion Criteria:

1. Patients that refuse and/or are not able to sign the Informed Consent;
2. Parents/guardians or subjects who, in the opinion of the Investigator, may be noncompliant with study schedules or procedures;
3. 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.

• BACKGROUNDBrahmer 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 29442540