JAPANESE PROSPECTIVE REAL WORLD REGISTRY OF NIVOLUMAB PLUS IPILIMUMAB IN SUBJECTS WITH PREVIOUSLY UNTREATED, ADVANCED OR METASTATIC RENAL CELL CARCINOMA (ARCC) CATEGORIZED INTO IMDC INTERMEDIATE/POOR RISKS (J-ENCORE)
Not Applicable
Completed
- Conditions
- ADVANCED OR METASTATIC RENAL CELL CARCINOMA
- Registration Number
- JPRN-UMIN000036772
- Lead Sponsor
- Bristol-Myers Squibb K.K. Ono Pharmaceutical CO.,LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 286
Inclusion Criteria
Not provided
Exclusion Criteria
1. combination therapy in Japan 2. Pregnant and/or lactating women 3. Patients who are judged to be inappropriate by investigator
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate [ORR]
- Secondary Outcome Measures
Name Time Method Overall survival [OS] Progression-free survival [PFS] Change in tumor response overtime Duration of response Quality of life (QOL) Incidence/rate of adverse events The number of doses of nivolumab plus ipilimumab therapy The rate of subsequent therapy ORR on subsequent therapy