Trial to Evaluate irAEs With Different Standard of Care Dosing Strategies of Standard of Care Immunotherapies

Inclusion criteria

• Ability of participant to understand this study, and participant willingness to sign a written informed consent.
• Males and females age ≥ 18 years
• ECOG Performance Status (PS) 0 - 2 (Appendix A.)
• Females of childbearing potential must have a negative urine pregnancy test 72 hours prior to initiating treatment.
• Histologically or cytologically confirmed diagnosis of solid tumor malignancy
• Eligible to receive pembrolizumab or nivolumab based therapy
• Any disease setting (neoadjuvant, adjuvant, unresectable, metastatic) or any line of therapy is allowed. NOTE: Standard of care combination agents(chemotherapy, targeted therapy, biologics) are allowed because irAEs are the primary objective
• Adequate organ function, defined as follows:

Leukocytes (White Blood Cell [WBC]) >1.0 K/UL Absolute Neutrophil Count >1.0 K/UL Platelets > 50 K/UL Hemoglobin ≥ 7 g/dL Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault equation Total bilirubin ≤ 1.5 x ULN Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN

Exclusion criteria

• Simultaneously enrolled in any therapeutic clinical trial
• Concurrent or planned use of other immunotherapies or radiation
• Has not recovered from irAEs due to prior immunotherapy treatment (>=grade 2 is considered not recovered). Conditions that meet grade 2 criteria but are considered clinically stable at the discretion of the investigator will be allowed.
• Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
• Currently pregnant or breastfeeding
• Has a known allergic reaction to any excipient contained in the study drug formulation
• Active Grade 3 (per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 ) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment.