Real-Life Effectiveness and Safety in Participants With Advanced/Metastatic Renal Cell Carcinoma Starting 1st Line Nivolumab and Ipilimumab Combination Therapy or Nivolumab Monotherapy After Prior Therapy
- Conditions
- Renal Cell Carcinoma
- Registration Number
- NCT02940639
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 499
Adult participants, at least 18 years of age at time of treatment decision
- Diagnosis of advanced/metastatic renal cell carcinoma (RCC) (confirmed by histology or cytology)
- Treatment decision to initiate a treatment with nivolumab and ipilimumab or nivolumab for the first time for the treatment of advanced/metastatic RCC (according to the label approved in Germany) has already been taken
- Signed informed consent
- Participants with a diagnosis of a cancer other than advanced/metastatic advanced RCC within the past five years, ie, a cancer other than advanced/metastatic RCC that requires systemic or other treatment. Participants that have been treated curatively more than five years ago with no evidence of recurrence and prostate cancer patients in active surveillance can be included.
- Participants previously treated with nivolumab and/or ipilimumab
- Participants currently included in an interventional clinical trial for their locally advanced or metastatic RCC. Participants who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for OS can be enrolled.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Approximately 5 years In participants with nivolumab and ipilimumab or nivolumab therapy
- Secondary Outcome Measures
Name Time Method Distribution of Adverse Events (AE) characteristics Approximately 5 years Progression-Free Survival (PFS) Approximately 5 years Overall response rate (ORR) Approximately 5 years Best Overall Response Rate (BORR) Approximately 5 years Distribution of socio-demographic characteristics Approximately 5 years Socio-demographic characteristics (Gender, Height, Weight, Age) will be summarized using descriptive statistics.
Distribution of clinical characteristics Approximately 5 years Clinical characteristics (Initial Diagnosis of RCC, Histological subtypes, Performance status, Comorbidities, history of cancer) will be summarized using descriptive statistics
Incidence rate of Adverse Events (AEs), treatment-related AEs, select AEs and other immune-related AEs Approximately 5 years Distribution of management of Adverse Events (AEs) Approximately 5 years Quality of Life as assessed by Functional Assessment of Cancer Therapy - Kidney Symptom Index (FKSI-19) Questionnaire Approximately 5 years Overall Survival (OS) Approximately 5 years 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.
Distribution of Renal Cell Carcinoma (RCC) Treatment History At Baseline Distribution of severity of Adverse Events (AEs) Approximately 5 years Best Overall Response (BOR) Approximately 5 years Distribution of Nivolumab Treatment Characteristics At initiation - index date, baseline Nivolumab monotherapy (cohort 1) or nivolumab and ipilimumab combination therapy (cohort 2)
Distribution of Treatment Patterns Approximately 5 years Details on prior and evolution of current treatment patterns
Utility as assessed by European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Approximately 5 years Duration of Response Approximately 5 years
Trial Locations
- Locations (1)
Local Institution
🇩🇪Jena, Germany