Status:
RECRUITING
Nivolumab Dose Optimization in Patients With a Complete, Partial or Stable Response
Lead Sponsor:
Erasmus Medical Center
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- Unable to draw blood for study purposes
- Patients willing to participate or already included in the SAFE-STOP trial
Key Trial Info
Start Date :
January 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06116461
Start Date
January 5 2022
End Date
January 1 2025
Last Update
April 22 2024
Active Locations (1)
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1
Erasmus MC
Rotterdam, Pending, Netherlands