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.
Study Type
OBSERVATIONAL
Enrollment
286
Local Institution - 0001
Tokyo, Japan
Objective Response Rate (ORR)
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: From date of starting nivolumab plus ipilimumab to the date of death from any cause. (Up to 5 years)
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator
Time frame: From date of starting nivolumab plus ipilimumab to the first date of documented progression, as determined by the investigators (as per RECIST 1.1 criteria), or death due to any cause, whichever occurs first. (Up to 5 years)
Change in tumor response over time
Time frame: Up to 5 years
Duration of Response (DOR)
Time frame: From first documentation of tumor response after the date of starting nivolumab plus ipilimumab to disease progression or death due to any cause, whichever occurs first. (Up to 5 years)
The quality of life by National Comprehensive Cancer Network/ Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) v2.0
Time frame: Up to 6 months
Number of participants with Adverse Events (AEs)
Time frame: During the observation period or until 100 days after discontinuation of dosing with nivolumab and ipilimumab (Up to 5 years)
ORR on subsequent therapy
Time frame: From initiation of a second line of therapy after discontinuation of first line nivolumab+ipilimumab treatment (Up to 5 years)
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