Advanced Renal Cell Carcinoma (All Subtypes), Metastatic Renal Cell Carcinoma (All Subtypes)
Conditions
Brief summary
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.
Interventions
OTHERDocumentation
Retrospective chart review of patients who have already completed treatment with cabozantinib after nivolumab or nivolumab plus ipilimumab before inclusion.
Sponsors
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject 2. Patients with advanced or metastatic renal cell carcinoma, including all subtypes 3. Age ≥ 18 years 4. Completion of treatment with nivolumab or nivolumab / ipilimumab combination therapy (any line of therapy) directly followed by cabozantinib treatment
Exclusion criteria
1. Patients who are unable to consent because they do not understand the nature, significance and implications of the observational trial 2. Involvement in the planning and / or conduct of the study (applies to both Ipsen staff and/or staff of sponsor and study site)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of serious adverse events | through study completion, an average of 1 year | Incidence of serious adverse events at least possibly related to cabozantinib treatment during and up to 30 days after the end of cabozantinib treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response | through study completion, an average of 1 year | Duration of response in months |
| number of terminations of cabozantinib treatment due to adverse events | through study completion, an average of 1 year | number of terminations of cabozantinib treatment due to adverse events |
| ORR | through study completion, an average of 1 year | ORR (investigator assessed; acc. RECIST v1.1 if available) |
| Clinical benefit rate (CBR) | through study completion, an average of 1 year | Clinical benefit rate (CBR) |
| number of dose interruptions | through study completion, an average of 1 year | number of dose interruptions |
| Duration of cabozantinib treatment | through study completion, an average of 1 year | Duration of cabozantinib treatment in months |
| Time to next treatment | From date of last dose of cabozantinib until the date of first dose of next treatment, assessed up to 100 months | Time to next treatment in months |
| Safety in IO-cabozantinib-sequence compared to cabozantinib single agent therapy historical data | through study completion, an average of 1 year | Safety in IO-cabozantinib-sequence compared to cabozantinib single agent therapy historical data |
| Comparison of effectiveness endpoints of IO-cabozantinib-sequence to historical efficacy data (ORR, CBR) | through study completion, an average of 1 year | Comparison of effectiveness endpoints of IO-cabozantinib-sequence to historical efficacy data (ORR, CBR) |
| number of dose reductions | through study completion, an average of 1 year | number of dose reductions |
Countries
Germany
Outcome results
None listed