Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants with advanced/metastatic renal cell cancer (RCC) starting nivolumab monotherapy after prior therapy | ||
| Cohort 2 | Participants with advanced/metastatic RCC starting 1st line therapy with nivolumab and ipilimumab combination therapy, in intermediate/poor risk participants |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | In participants with nivolumab and ipilimumab or nivolumab therapy | Approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 5 years |
| Progression-Free Survival (PFS) |
Not provided
Inclusion Criteria:
Adult participants, at least 18 years of age at time of treatment decision
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult participants who are at least 18 years of age at the time of the treatment decision with the diagnosis of advanced/metastatic RCC (histologically or cytologically confirmed) and whose physician has already decided to initiate a treatment with 1st line nivolumab and ipilimumab nivolumab combination therapy in intermediate/poor risk participants according to International Metastatic RCC Database Consortium (IMDC) score or with nivolumab monotherapy after prior therapy for the first time for the treatment of advanced/metastatic RCC, according to the label approved in Germany.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Jena | 07743 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29325434 | Derived | Bedke J, Grimm MO, Grunwald V. Collection of real-world data on nivolumab's effectiveness in renal cell carcinoma: rationale for an observational study. Future Oncol. 2018 May;14(11):1023-1034. doi: 10.2217/fon-2017-0637. Epub 2018 Jan 12. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | Socio-demographic characteristics (Gender, Height, Weight, Age) will be summarized using descriptive statistics. | 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 | Approximately 5 years |
| Distribution of Renal Cell Carcinoma (RCC) Treatment History | At Baseline |
| Distribution of Nivolumab Treatment Characteristics | Nivolumab monotherapy (cohort 1) or nivolumab and ipilimumab combination therapy (cohort 2) | At initiation - index date, baseline |
| Distribution of Treatment Patterns | Details on prior and evolution of current treatment patterns | Approximately 5 years |
| 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 |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided