MedPath

ivolumab dose optimization during nivolumab therapy in melanoma patients after achieving a complete, partial or stable response (NIVOPTIMIZE-trial)

Recruiting
Conditions
melanoma
skin cancer
10040900
Registration Number
NL-OMON54156
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
34
Inclusion Criteria

1. Age >= 18 years
2. Advanced or metastatic melanoma or renal cell carcinoma
3. Current treatment with nivolumab in a 480 mg or 6mg/kg, 4 weekly scheme
4. Documented confirmed and ongoing CR, PR or SD according to RECIST v1.1
5. 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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath