Phase 3/4 open label, randomized two cohort study (2 arms in each cohort).
It is hypothesized that for people with a histologically or cytologically confirmed diagnosis of malignancy, the higher dose immunotherapy (every 6 weeks Pembrolizumab 400mg dose and every 4 weeks Nivolumab 480mg dose) has more immune-related adverse events irAEs compared to lower dose (every 3 weeks Pembrolizumab 200mg dose and every 2 weeks Nivolumab 240mg dose).
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.
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
Parallel
Nivolumab
DrugImmunotherapy
Pembrolizumab
DrugImmunotherapy
Proportions of grade ≥3 immune related adverse events (irAEs) between the two arms in each cohort
Measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
All grades of immune related adverse events (irAEs)
Measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
Time to resolution of immune related adverse events (irAEs)
Measured by The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
Time of treatment discontinuation due to immune related adverse events (irAEs)
Duration of time from start of treatment to discontinuation, determined by medical record
Overall Response Rate (ORR)
Measured by response evaluation criteria in solid tumors (RECIST) and medical record.
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