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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Kansas Medical Center

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 dose and every 2 weeks Nivolumab 240mg dose).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Nivolumab
  • Pembrolizumab

Treatment groups

192 Participants
are divided into 2 treatment groups