Identification of Pathways to Mitigate Immune-Related Adverse Events With Cancer Immunotherapy

Inclusion Criteria

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, >18 yo
• Diagnosis of solid tumor including, but not limited to, genitourinary/gynecologic, lung, gastrointestinal and melanoma
• Receiving, or prior to starting on, a checkpoint inhibitor
• Grade ≥ 2 ircAE (CTCAE v 5.0) (for cohort 1 only)
• An indication for system corticosteroids or biologic therapies as determined by the treating physician (for cohort 1 only)
• Life expectancy ≥ 12 weeks

Exclusion Criteria

• Daily use of systemic steroid treatment in the past 4 weeks (prednisone >10mg a day or equivalent) except for indications other than the cutaneous adverse event, and/or as an anti-emetic pre- or post-chemotherapy infusions.
• Enrollment in any investigational drug trial with a drug that has not been approved
• Taking other checkpoint inhibitors beyond anti-PD-(L)-1 or anti-CTLA-4 not yet indicated/approved for use
• Pregnancy
• Known blood borne infectious disease
• Current or pervious diagnosis of a leukemia or lymphoma
• Unable to give consent for study participation
• Life expectancy < 12 weeks
• Any other condition or diagnosis in the opinion of the investigator that would interfere with the study results