Clinical Research on the efficacy evaluation and the biomarker of nivolumab to an advance malignant melanoma
Not Applicable
- Conditions
- malignant melanoma
- Registration Number
- JPRN-UMIN000016608
- Lead Sponsor
- Public Health Research Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 128
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients with comorbid active infection 2)Patients with interstitial lung disease or pulmonary fibrosis 3)Patients who are or may be pregnant 4)Patients who are difficult to treat due to psychosis or psychiatric symptoms 5)Patients judged to be ineligible for the study by an attending physician
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Response rate (RR) by RECIST 2)Overall Survival (OS)
- Secondary Outcome Measures
Name Time Method 1)Progression-free Survival (PFS) 2)Response rate by Immune-Related Response Criteria (irRECIST) 3)Information on drug therapies after discontinuation/completion of administration of nivolumab 4)Selection of the factors predictive of treatment response after administration of nivolumab