Multi-disciplinary research for predictive factors of nivolumab effect on unresectable or metastatic renal cell carcinoma
- Conditions
- nresectable or metastatic renal cell carcinoma
- Registration Number
- JPRN-UMIN000031541
- Lead Sponsor
- Graduate School of Pharmaceutical Sciences Department of Urology, Graduate School of Medicine Osaka University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Not provided
1)Patients with known or previous antoimmune disease 2)Patients who are currently administered corticosteroids 3)Patients with prior therapy by antibody or drug, specifically aiming at regulation of T-cell functions 4)Patients with history of serious anaphylaxis induced by the component of this agent 5)Dementia or psychological disorder difficult to participate in this clinical study 6)Patients with severe complications (active gastrointestinal ulceration, ileus, bowel obstruction, and uncontrolled diabetes mellitus, etc.) 7)Patients with HIV antibody-positive, HBs antibody-positive, or HCV antibody-positive 8)Patients with HBs antigen-negative, HBs antibody- or HBc antibody-positive, and HBV-DNA quantitative test-positive 9)Pregnant or breast-feeding women or women suspected of being pregnant 10)Other cases judged inappropriate by the attending
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival at 6 months after Nivolumab administration
- Secondary Outcome Measures
Name Time Method Efficacy: Overall survival Safety: Rate of side effects