Optimizing nivolumab dosing for melanoma patients with positive treatment responses
Nivolumab Dose Optimization in Patients With a Complete, Partial or Stable Response
This study is testing if lower doses of nivolumab can be just as effective for melanoma patients who are responding well to treatment, to help reduce unnecessary medication use.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | nivolumab, ipilimumab |
| Locations | 1 site (Rotterdam, Pending) |
| Trial ID | NCT06116461 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the optimal dosing of nivolumab in patients with advanced melanoma who have shown a complete, partial, or stable response to treatment. The study aims to evaluate nivolumab trough levels to determine if lower doses could be effective, given that higher doses may not significantly improve outcomes. Participants will be monitored for their response to treatment while receiving nivolumab in a specific dosing regimen. The goal is to enhance treatment efficacy while potentially reducing unnecessary drug exposure.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced or metastatic melanoma currently receiving nivolumab treatment and showing a positive response.
Not a fit: Patients who are unable to provide blood samples for study purposes or those already participating in the SAFE-STOP trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized dosing strategies for melanoma patients, improving treatment outcomes.
How similar studies have performed: Other studies have explored dosing optimization in immunotherapy, but this specific approach to nivolumab dosing is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rotterdam, Pending
- Erasmus MC — Rotterdam, Pending, Netherlands (Recruiting)
Study contacts
- Study coordinator: Michiel Zietse, MSc
- Email: michielzietse@gmail.com
- Phone: +31642534225
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.