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.
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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