Renal Cell Carcinoma
Conditions
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
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Approximately 5 years | In participants with nivolumab and ipilimumab or nivolumab therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 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 | — |
| Distribution of Nivolumab Treatment Characteristics | At initiation - index date, baseline | Nivolumab monotherapy (cohort 1) or nivolumab and ipilimumab combination therapy (cohort 2) |
Countries
Germany
Outcome results
None listed