Collection of Research Data and Samples From Patients Who Experience Immunotherapy Side Effects

PRIMARY OBJECTIVES:

To establish a national biorepository including biospecimen and clinical data collections from patients treated with immuno-oncology (IO) therapeutics who experience one or more serious (grade 3-4) immune-related adverse events (irAEs), rare infections or hyperprogression (acceleration of tumor growth).

OUTLINE:

Patients undergo collection of tissue and blood samples (and optional stool samples from patients experiencing colitis) at the time of registration (within 72 hours of confirmation of one or more severe irAEs) and at 1 month after registration. Patients' medical records are also reviewed for up to 1 year.

Inclusion criteria

• Received a regimen containing one or more immuno-oncology therapeutics
• Must have experienced one or more of the following:

• One or more serious (Grade 3-4) AEs that are likely immune-related
• One or more Grade 2 dermatologic or rheumatologic AEs that are likely immune-related
• Diagnosis of a rare infection, e.g., fungal or mycobacterial, after starting IO treatment

** Note: Diagnosis of SARS-CoV-2 (COVID-19) is excluded

• Hyperprogression. Image submission for patients experiencing hyperprogression is required. For assistance in determining hyperprogression for purposes of eligibility, institutions may contact the study chair and submit images for central review
• Has not previously been registered to this study