Nivolumab Dose Optimization in Patients With a Complete, Partial or Stable Response (NIVOPTIMIZE)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Age ≥ 18 years
- Advanced or metastatic melanoma
- Current treatment with nivolumab for advanced or metastatic melanoma, in a 6 mg/kg or 480 mg, 4 weekly scheme
- Documented confirmed and ongoing CR, PR or SD according to RECIST v1.1
- On treatment for at least 6 months
Exclusion criteria
- Unable to draw blood for study purposes
- Patients willing to participate or already included in the SAFE-STOP trial
Trial design
Primary purpose
Allocation
Interventional model
Masking
34 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Michiel Zietse, MSc
Data sourced from clinicaltrials.gov
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