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Trial Title:
Nivolumab Dose Optimization in Patients With a Complete, Partial or Stable Response
NCT ID:
NCT06116461
Condition:
Melanoma
Conditions: Official terms:
Melanoma
Nivolumab
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Nivolumab
Description:
Participants receive three reduced doses of 240 mg every four weeks
Arm group label:
Nivolumab
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Erasmus MC
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Michiel MC
Email:
m.zietse@erasmusmc.nl
Start date:
January 5, 2022
Completion date:
January 2025
Lead sponsor:
Agency:
Erasmus Medical Center
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06116461
