Trial to Evaluate irAEs With Different Standard of Care Dosing Strategies of Standard of Care Immunotherapies
Phase 3
192
about 4 years
18+
1 site in KS
What this study is about
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.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Nivolumab
- 2.Take Pembrolizumab
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
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)
infusion
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)
Oncology