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)

简要总结

主要结局

次要结局

• Overall Survival (OS)(From date of starting nivolumab plus ipilimumab to the date of death from any cause. (Up to 5 years))
• Duration of Response (DOR)(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(Up to 6 months)
• ORR on subsequent therapy(From initiation of a second line of therapy after discontinuation of first line nivolumab+ipilimumab treatment (Up to 5 years))
• Change in tumor response over time(Up to 5 years)
• Number of participants with Adverse Events (AEs)(During the observation period or until 100 days after discontinuation of dosing with nivolumab and ipilimumab (Up to 5 years))
• Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator(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))