Alliance for Clinical Trials in Oncology
This study 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.
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 96 hours of confirmation of one or more severe irAEs) and at 1 month after registration. Patients' medical…
* PRE-REGISTRATION ELIGIBILITY CRITERIA: Planning to receive a regimen containing one or more IO therapeutics * PRE-REGISTRATION ELIGIBILITY CRITERIA: Has not previously been treated with CTLA-4, PD-1 or PD-L1 inhibitors * PRE-REGISTRATION ELIGIBILITY CRITERIA: Willing and able to provide baseline blood and stool samples * REGISTRATION ELIGIBILITY CRITERIA: Received a regimen containing one or more immuno-oncology therapeutics * Must have received one or more IO therapeutics * In addition to one or more IO therapeutics, patients may also have received other therapeutics such as chemothera…
Undergo collection of tissue, blood, and stool samples
Review of medical records