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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Erasmus MC
RECRUITING
Rotterdam
Contact Information
Primary
Michiel Zietse, MSc
michielzietse@gmail.com
+31642534225
Time Frame
Start Date: 2022-01-05
Estimated Completion Date: 2025-01
Participants
Target number of participants: 34
Treatments
Experimental: Nivolumab
Patients in the experimental arm receive three reduced nivolumab doses of 240 mg Q4W
Related Therapeutic Areas
Sponsors
Leads: Erasmus Medical Center

This content was sourced from clinicaltrials.gov

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