CaboCHECK - Cabozantinib in Adult Patients With Advanced Renal Cell Carcinoma Following Prior Systemic Check Point Inhibition Therapy: a Retrospective, Non-interventional Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- number of dose reductions [through study completion, an average of 1 year]
number of dose reductions
- number of dose interruptions [through study completion, an average of 1 year]
number of dose interruptions
- 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)
- Duration of response [through study completion, an average of 1 year]
Duration of response in months
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject
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Patients with advanced or metastatic renal cell carcinoma, including all subtypes
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Age ≥ 18 years
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Completion of treatment with nivolumab or nivolumab / ipilimumab combination therapy (any line of therapy) directly followed by cabozantinib treatment
Exclusion Criteria:
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Patients who are unable to consent because they do not understand the nature, significance and implications of the observational trial
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Involvement in the planning and / or conduct of the study (applies to both Ipsen staff and/or staff of sponsor and study site)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Uniklinik Essen | Essen | Nordrhein-Westfalen | Germany | 45147 |
| 2 | Uniklinik Münster | Münster | Nordrhein-Westfalen | Germany | 48147 |
Sponsors and Collaborators
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Investigators
- Study Director: Salah-Eddin Al-Batran, Prof. Dr., Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CaboCHECK