ADVANCED OR METASTATIC RENAL CELL CARCINOMA
Conditions
Interventions
None listed
Sponsors
Bristol-Myers Squibb K.K. Ono Pharmaceutical CO.,LTD.
The Japanese Urological Association
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histological confirmation of RCC 2. No prior systemic therapy for RCC 3. RCC patients who are planned to start treatment with nivolumab and ipilimumab regimen in the timeframe between after IRB approval to enrollment-end date 4. IMDC risk category Intermediate and Poor 5. Over 20 years old patients for whom informed consent was obtained from the patient at the time of this study participation
Exclusion criteria
Exclusion criteria: 1. combination therapy in Japan 2. Pregnant and/or lactating women 3. Patients who are judged to be inappropriate by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate [ORR] | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactKeisuke Hirota
Mebix, Inc Oncology Group
Outcome results
None listed