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

Recruiting Phase 3 Interventional Study
Solid Tumor Malignancies
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
192 (estimated)
Sponsor
University of Kansas Medical Center · Other
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About This Trial
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 do…
Trial Locations
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Eligibility Criteria
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 t…
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