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ivolumab dose optimization in patients with a complete, partial or stable response (NIVOPTIMIZE-trial)

Phase 1
Conditions
Melanoma, Renal cell carcinoma
Therapeutic area: Diseases [C] - Neoplasms [C04]
Registration Number
CTIS2024-516718-39-00
Lead Sponsor
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
34
Inclusion Criteria

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

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 clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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