A Late Phase Randomized Open-Label Multi Cohort Trial to Evaluate irAEs With Different Standard of Care Dosing Strategies of Standard of Care Immunotherapies
University of Kansas Medical Center
Summary
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. NOT…
Interventions
- DrugNivolumab
Immunotherapy
- DrugPembrolizumab
Immunotherapy
Location
- The University of Kansas Cancer CenterWestwood, Kansas