Nivolumab Dose Optimization in Patients With a Complete, Partial or Stable Response - Trial NCT06116461

Timeline & Enrollment

Primary Outcome

Difference between the nivolumab mean trough level after 3 reduced doses (240 mg every 4 weeks) and after the first dose of 6 mg/kg or 480 mg.

Summary

Patients with advanced melanoma are, amongst others, currently treated with nivolumab
 monotherapy or with nivolumab and ipilimumab followed by nivolumab. Even though registration
 studies administered nivolumab in a 3 mg/kg 2 weekly scheme, currently, nivolumab monotherapy
 is either administered in a 240 mg 2-weekly scheme or in a 6 mg/kg or 480 mg 4-weekly scheme.
 With the current dosing regimen, steady-state is achieved after approximately 5 to 6 months,
 whereas a tumour response is usually observed earlier in patients with metastatic melanoma.
 Moreover, PD-1 receptor occupancy is almost saturated above doses of 0.3 mg/kg, or at
 nivolumab serum levels of 10 mg/L, which is a concentration that is achieved after one
 treatment cycle. In melanoma patients, the additional probability on response in patients
 treated with 3 mg/kg compared to 1 mg/kg seems limited. PFS and OS for 3 mg/kg were not
 superior to 1 mg/kg. Therefore, in this study, our aim is to investigate nivolumab trough
 levels and pharmacokinetic parameters after 3 reduced nivolumab doses.

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