Advanced Renal Cell Carcinoma (All Subtypes) Clinical Trial
Official title:
Cabozantinib in Adult Patients With Advanced Renal Cell Carcinoma Following Prior Systemic Check Point Inhibition Therapy: a Retrospective, Non-interventional Study
| NCT number | NCT04147143 |
| Other study ID # | CaboCHECK |
| Secondary ID | |
| Status | Terminated |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 8, 2019 |
| Est. completion date | February 28, 2021 |
| Verified date | December 2022 |
| Source | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 56 |
| Est. completion date | February 28, 2021 |
| Est. primary completion date | February 28, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Uniklinik Essen | Essen | Nordrhein-Westfalen |
| Germany | Uniklinik Münster | Münster | Nordrhein-Westfalen |
| Lead Sponsor | Collaborator |
|---|---|
| Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | number of dose reductions | number of dose reductions | through study completion, an average of 1 year | |
| Secondary | number of dose interruptions | number of dose interruptions | through study completion, an average of 1 year | |
| Secondary | 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 | |
| Secondary | ORR | ORR (investigator assessed; acc. RECIST v1.1 if available) | through study completion, an average of 1 year | |
| Secondary | Clinical benefit rate (CBR) | Clinical benefit rate (CBR) | through study completion, an average of 1 year | |
| Secondary | Duration of response | Duration of response in months | through study completion, an average of 1 year | |
| Secondary | Duration of cabozantinib treatment | Duration of cabozantinib treatment in months | through study completion, an average of 1 year | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |