The purpose of this study is to estimate overall survival over a 5-year follow-up period among adult participants with advanced/metastatic kidney cancer, starting 1st line nivolumab and ipilimumab combination therapy or nivolumab monotherapy after prior therapy, in real-life conditions in Germany
Study Type
OBSERVATIONAL
Enrollment
499
Local Institution - 0001
Jena, Germany
Overall Survival (OS)
In participants with nivolumab and ipilimumab or nivolumab therapy
Time frame: Approximately 5 years
Overall Survival (OS)
Separate by nivolumab and ipilimumab or nivolumab therapy, estimated overall lines of therapy, per line of therapy, per cohort, per index date (initial diagnosis vs start of therapy in the trial) and per subgroups of interest.
Time frame: Approximately 5 years
Progression-Free Survival (PFS)
Time frame: Approximately 5 years
Overall response rate (ORR)
Time frame: Approximately 5 years
Best Overall Response (BOR)
Time frame: Approximately 5 years
Best Overall Response Rate (BORR)
Time frame: Approximately 5 years
Duration of Response
Time frame: Approximately 5 years
Distribution of socio-demographic characteristics
Socio-demographic characteristics (Gender, Height, Weight, Age) will be summarized using descriptive statistics.
Time frame: Approximately 5 years
Distribution of clinical characteristics
Clinical characteristics (Initial Diagnosis of RCC, Histological subtypes, Performance status, Comorbidities, history of cancer) will be summarized using descriptive statistics
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Time frame: Approximately 5 years
Distribution of Renal Cell Carcinoma (RCC) Treatment History
Time frame: At Baseline
Distribution of Nivolumab Treatment Characteristics
Nivolumab monotherapy (cohort 1) or nivolumab and ipilimumab combination therapy (cohort 2)
Time frame: At initiation - index date, baseline
Distribution of Treatment Patterns
Details on prior and evolution of current treatment patterns
Time frame: Approximately 5 years
Incidence rate of Adverse Events (AEs), treatment-related AEs, select AEs and other immune-related AEs
Time frame: Approximately 5 years
Distribution of Adverse Events (AE) characteristics
Time frame: Approximately 5 years
Distribution of severity of Adverse Events (AEs)
Time frame: Approximately 5 years
Distribution of management of Adverse Events (AEs)
Time frame: Approximately 5 years
Quality of Life as assessed by Functional Assessment of Cancer Therapy - Kidney Symptom Index (FKSI-19) Questionnaire
Time frame: Approximately 5 years
Utility as assessed by European Quality of Life-5 Dimensions (EQ-5D) Questionnaire
Time frame: Approximately 5 years