A Phase 4 interventional study of Nivolumab in Melanoma, sponsored by Erasmus Medical Center. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-22.
Sponsored by Erasmus Medical Center · Phase 4, Interventional, and Treatment
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's planned enrollment of 34 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
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Exclusion Criteria:
Patients in the experimental arm receive three reduced nivolumab doses of 240 mg Q4W
Drug: Nivolumab
Participants receive three reduced doses of 240 mg every four weeks
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.
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.
Time frame: Through study completion, an average of four months
- PD-1 receptor occupancy in PBMCs, measured 4 weeks after 3 reduced nivolumab doses
- PD-1 receptor occupancy in PBMCs, measured 4 weeks after 3 reduced nivolumab doses
Time frame: Through study completion, an average of four months
Grade ≥3 adverse events (CTCAE) during reduced doses
Grade ≥3 adverse events (CTCAE) during reduced doses
Time frame: Through study completion, an average of four months
Number of patients with new PD during 3 reduced doses
Number of patients with new PD during 3 reduced doses
Time frame: Through study completion, an average of four months
Plan to share: No
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Erasmus Medical Center