Ipilimumab plus nivolumab with prophlactic dexamethasone in patients with advanced renal cell carcinoma
- Conditions
- Renal cell carcinomaadvanced renal cell carcinomaD002292
- Registration Number
- JPRN-jRCTs041210108
- Lead Sponsor
- Hamamoto Shuzo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
(1) 20-90 years old patients who were diagnosed as advanced renal cell carcinoma and had an indication for Ipilimumab plus nivolumab therapy
(2) Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0, 1, 2, or 3
(3) labolatory data includes the following criteria
a) WBC: more than 3,000 /mm3
b) Hb: more than 8.0g/dL
c) PLT: more than 100000/mm3
d) AST(GOT), ALT(GPT): AST Less than 66 mg/dL, ALT Less than 54 mg/dL
e) Total Bil: Less than 1.5mg/dL
(4) Patients who can get hospitalized for this study
(5) Patients who were obtained written informed consent
(1) women with pregnant or its possibily
(2) Hisory of Having allegies to ipilimumab or nivolumab therapy
(3) active multiple cancer
(4) Taking a steroid or immunosuppressive drug
(5) uncontoralble diabetes
(6) Judged as an inappropriate patient by the investigator or sub-investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method