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

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).

NCT Number	NCT07174453
Lead Sponsor	University of Kansas Medical Center
Conditions	Solid Tumor Malignancies
Enrollment	192 participants
Start Date	2025-10-07
Primary Completion	2027-10-01 (estimated)
Study Completion	2029-10-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-01