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
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort 1 Participants with advanced/metastatic renal cell cancer (RCC) starting nivolumab monotherapy after prior therapy |
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| Cohort 2 Participants with advanced/metastatic RCC starting 1st line therapy with nivolumab and ipilimumab combination therapy, in intermediate/poor risk participants |
Outcome Measures
Primary Outcome Measures
- Overall Survival (OS) [Approximately 5 years]
In participants with nivolumab and ipilimumab or nivolumab therapy
Secondary Outcome Measures
- 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.
- Progression-Free Survival (PFS) [Approximately 5 years]
- Overall response rate (ORR) [Approximately 5 years]
- Best Overall Response (BOR) [Approximately 5 years]
- Best Overall Response Rate (BORR) [Approximately 5 years]
- Duration of Response [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
- Distribution of Renal Cell Carcinoma (RCC) Treatment History [At Baseline]
- 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
- Incidence rate of Adverse Events (AEs), treatment-related AEs, select AEs and other immune-related AEs [Approximately 5 years]
- Distribution of Adverse Events (AE) characteristics [Approximately 5 years]
- Distribution of severity of Adverse Events (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]
- Utility as assessed by European Quality of Life-5 Dimensions (EQ-5D) Questionnaire [Approximately 5 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
Adult participants, at least 18 years of age at time of treatment decision
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Diagnosis of advanced/metastatic renal cell carcinoma (RCC) (confirmed by histology or cytology)
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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
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Signed informed consent
Exclusion Criteria:
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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.
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Participants previously treated with nivolumab and/or ipilimumab
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Jena | Germany | 07743 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- FDA Safety Alerts and Recalls
- BMS Clinical Trial Patient Recruiting
- Investigator Inquiry Form
Publications
None provided.- CA209-653