Collection of Research Data and Samples From Patients Treated With Immunotherapy to Study Its Side Effects

Criteria the registry did not label

• 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 chemotherapy, hormonal or targeted therapy, as long as these are reported
• REGISTRATION ELIGIBILITY CRITERIA: Must have experienced one or more of the following:
  • One or more serious (grade 3-54) AEs that are likely immune-related. AEs included in Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0 that may be immune-related
  • \*\* Patients who experience only hematologic cytopenia(s) who have received cytotoxic therapies, e.g., chemotherapy, within 60 days prior to registration should be excluded
  • One or more grade 2 dermatologic, endocrine (except diabetes/hyperglycemia) or rheumatologic AEs that are likely immune-related. AEs included in CTCAE v. 5.0 that may be 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
• REGISTRATION ELIGIBILITY CRITERIA: Has not previously been registered to this study \* The same patient cannot be enrolled more than once to this study due to development of subsequent irAEs