Overview
This trial collects research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. Studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects.
Description
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 3-5) immune-related adverse events (irAEs), rare infections or hyperprogression (acceleration of tumor growth).
OUTLINEPatients 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.
Eligibility
Inclusion Criteria:
- Must have received one or more IO therapeutics
- Must have experienced one or more of the following:
- One or more serious (grade 3-5) AEs that are likely immune-related
- Diagnosis of a rare infection, e.g., fungal or mycobacterial, after starting IO treatment
- 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