ivolumab dose optimization in patients with a complete, partial or stable response (NIVOPTIMIZE-trial)
Phase 1
- Conditions
- Patients with advanced or metastatic melanoma or renal cell carcinoma treated with nivolumab monotherapy in a 480mg or 6 mg/kg 4 weekly scheme (either from start or after combination therapy with ipilimumab), have a confirmed CR, PR or SD, are at least 6 months on treatment and are willing to receive 3 reduced doses of 240 mgTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-001707-32-NL
- Lead Sponsor
- Erasmus Medical Center Rotterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 91
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 31
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
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
Name Time Method
- Secondary Outcome Measures
Name Time Method