Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Due to insufficient recruitment rate, recruitmend has been terminated after inclusion of 56 patients
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a non-interventional study to retrospectively evaluate the safety and to describe the effectiveness of cabozantinib after immunoncologic treatment with nivolumab or nivolumab plus ipilimumab in routine clinical practice. It consists of a retrospective chart review of patients who have already completed treatment with cabozantinib after nivolumab or nivolumab plus ipilimumab before inclusion.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Documentation | Other | Retrospective chart review of patients who have already completed treatment with cabozantinib after nivolumab or nivolumab plus ipilimumab before inclusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious adverse events | Incidence of serious adverse events at least possibly related to cabozantinib treatment during and up to 30 days after the end of cabozantinib treatment | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| number of dose reductions | number of dose reductions | through study completion, an average of 1 year |
| number of dose interruptions | number of dose interruptions |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adults ≥ 18 years with advanced or metastatic renal cell carcinoma (all subtypes) who have completed treatment with nivolumab or nivolumab plus ipilimumab (any line of systemic therapy) directly followed by cabozantinib treatment
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Salah-Eddin Al-Batran, Prof. Dr. | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniklinik Essen | Essen | North Rhine-Westphalia | 45147 | Germany | ||
| Uniklinik Münster |
No IPD will be shared
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| through study completion, an average of 1 year |
| number of terminations of cabozantinib treatment due to adverse events | number of terminations of cabozantinib treatment due to adverse events | through study completion, an average of 1 year |
| ORR | ORR (investigator assessed; acc. RECIST v1.1 if available) | through study completion, an average of 1 year |
| Clinical benefit rate (CBR) | Clinical benefit rate (CBR) | through study completion, an average of 1 year |
| Duration of response | Duration of response in months | through study completion, an average of 1 year |
| Duration of cabozantinib treatment | Duration of cabozantinib treatment in months | through study completion, an average of 1 year |
| Time to next treatment | Time to next treatment in months | From date of last dose of cabozantinib until the date of first dose of next treatment, assessed up to 100 months |
| Safety in IO-cabozantinib-sequence compared to cabozantinib single agent therapy historical data | Safety in IO-cabozantinib-sequence compared to cabozantinib single agent therapy historical data | through study completion, an average of 1 year |
| Comparison of effectiveness endpoints of IO-cabozantinib-sequence to historical efficacy data (ORR, CBR) | Comparison of effectiveness endpoints of IO-cabozantinib-sequence to historical efficacy data (ORR, CBR) | through study completion, an average of 1 year |
| Münster |
| North Rhine-Westphalia |
| 48147 |
| Germany |
| 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