Melanoma, Renal cell carcinoma
Conditions
Brief summary
Difference between the mean trough level 4 weeks after the 3rd nivolumab dose of 240 mg and the mean trough level 4 weeks after treatment start (i.e. 4 weeks after the first 6 mg/kg or 480 mg dose)
Detailed description
PD-1 receptor occupancy in PBMCs, measured 4 weeks after 3 reduced nivolumab doses, Grade ≥3 adverse events during reduced doses, Number of patients with new PD during 3 reduced doses, Pharmacokinetic profile of nivolumab, Cost effectiveness
Interventions
DRUGNIVOLUMAB
Sponsors
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between the mean trough level 4 weeks after the 3rd nivolumab dose of 240 mg and the mean trough level 4 weeks after treatment start (i.e. 4 weeks after the first 6 mg/kg or 480 mg dose) | — |
Secondary
| Measure | Time frame |
|---|---|
| PD-1 receptor occupancy in PBMCs, measured 4 weeks after 3 reduced nivolumab doses, Grade ≥3 adverse events during reduced doses, Number of patients with new PD during 3 reduced doses, Pharmacokinetic profile of nivolumab, Cost effectiveness | — |
Countries
Netherlands
Outcome results
None listed