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

University of Kansas Medical Center
NCT IDNCT07174453ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

192

Study length

about 4 years

Ages

18+

Locations

1 site in KS

About this study

Researchers are testing whether a higher dose of immunotherapy (every 6 weeks Pembrolizumab 400mg and every 4 weeks Nivolumab 480mg) causes more immune-related adverse events (irAEs) compared to a lower dose (every 3 weeks Pembrolizumab 200mg and every 2 weeks Nivolumab 240mg). The trial is for adults with solid tumors.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Nivolumab
  • 2.Take Pembrolizumab
PhasePhase 3
DrugNivolumab
Routeinfusion
Primary goalProportions of grade ≥3 immune related adverse events (irAEs) between the two arms in each cohort

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low14%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

nivolumab (Immune checkpoint inhibitor; blocks PD-1 receptor on T cells), pembrolizumab (Immune checkpoint inhibitor; blocks PD-1 to boost T-cell attack on cancer)

Drug routes

infusion

Endpoints

Primary: Proportions of grade ≥3 immune related adverse events (irAEs) between the two arms in each cohort

Secondary: All grades of immune related adverse events (irAEs), Disease-Free Survival (DFS), Overall Response Rate (ORR), Overall Survival (OS), Progression-Free Survival (PFS), Time of treatment discontinuation due to immune related adverse events (irAEs), Time to resolution of immune related adverse events (irAEs)

Body systems

Oncology