NCT06116461RecruitingPhase 4
Nivolumab dose optimization in patients with a complete, partial or stable response (NIVOPTIMIZE-trial)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 15 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Demonstrate that an adequate steady-state level is reached by showing that the mean trough level measured after 3 reduced doses of nivolumab 240 mg 4 weekly is not lower than the mean trough level 4 weeks after treatment start (i.e. 4 weeks after the dose of 6 mg/kg or 480 mg)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 30 Jul 2024
- Start date
- 15 Aug 2024
- Lead sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Diseases
- Kidney cancer, Melanoma
- NCT number
- NCT06116461
- EU CT number
- 2024-516718-39-00
- EudraCT number
- 2021-001707-32
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 34
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other
- Unable to draw blood for study purposes
- Patients willing to participate or already included in the SAFE-STOP trial
Who the study is looking for
- Age ≥ 18 years
- Advanced or metastatic melanoma or RCC
- Current treatment with nivolumab 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Isala Klinieken Stichting Coordinator of this site? Confirm its status | Zwolle | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.