A Study of Nivolumab Plus Ipilimumab in Participants With Renal Cell Cancer in the Real World Setting in Japan

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Advanced or Metastatic Renal Cell Carcinoma

Study type: Observational

Funder types: Industry

Identifiers

NCT04043975

CA209-7CR

Details and patient eligibility

About

The purpose of the observational study is to evaluate the safety and effectiveness of combination therapy with nivolumab and ipilimumab in Japanese participants with advanced or metastatic renal cell carcinoma (aRCC) in the real-world setting in Japan.

Enrollment: 286 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological confirmation of Renal Cell Carcinoma (RCC)
• No prior systemic therapy for RCC
• Participants who are planned to start treatment with nivolumab and ipilimumab regimen in the timeframe between after IRB approval to enrollment-end date
• International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category Intermediate/Poor

Exclusion criteria

• Participants who are enrolled in a post marketing safety study on nivolumab plus ipilimumab combination therapy in Japan
• Pregnant and/or lactating women
• Participants who are judged to be inappropriate by investigator

Other protocol-defined inclusion/exclusion criteria apply.

Trial design

286 participants in 1 patient group

Cohort 1

Description:

Participants with advanced or metastatic renal cell carcinoma (aRCC) receiving the combination of nivolumab plus ipilimumab as the first line of systemic therapy