Explorative study for biomarker of nivolumab for renal cell carcinoma
- Conditions
- renal cell carcinoma
- Registration Number
- JPRN-jRCTs051180102
- Lead Sponsor
- akano Yuzo
- Brief Summary
The study was discontinued because it was judged inappropriate to continue the study due to inappropriate cases in the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 141
Advanced renal cell carcinoma with unresectable or metastatic history who had been treated with tyrosine kinase inhibitors
Patients who have at least one tumorous lesion of 10 mm over in CT/ MRI and evaluated with RECIST ver1.1
Nuetrphils >= 1500 cells/mm3, platelets >= 75000 cells/mm3, hemoglobin >= 9.0 g/dl, AST <= 78IU/l, ALT <= 85IU/l, total bilirubin <= 1.5 mg/dl, serum creatinine <= 2.0 mg/dl
Over 20 years old patients
written informed consent
Patients who have been administered immune checkpoint inhibitors including nivolumab in the past
Patients with active infection of bacteria, fungi or viruses
Patients who have a history of malignant tumors other than renal cell carcinoma and are judged not to be cured
Patients suffering from other severe acute or chronic diseases
Pregnant women or women who may be pregnant or lactating women
Patients complicated with psychiatric disorders or psychiatric symptoms and judged to be difficult to participate in the study
Patients found to be unacceptable to components of test drugs (or excipients)
For other reasons, patients who judged ineligible for participation in this study by physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method