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

Inclusion Criteria

• •1. Ability of participant to understand this study, and participant willingness to sign a written informed consent.
• •2. Males and females age ≥ 18 years
• •3. ECOG Performance Status (PS) 0 - 2 (Appendix A.)
• •4. Females of childbearing potential must have a negative urine pregnancy test 72 hours prior to initiating treatment.
• •5. Histologically or cytologically confirmed diagnosis of solid tumor malignancy
• •6. Eligible to receive pembrolizumab or nivolumab based therapy
• •7. 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
• •8. 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