CaboCHECK - Cabozantinib in Adult Patients With Advanced Renal Cell Carcinoma Following Prior Systemic Check Point Inhibition Therapy: a Retrospective, Non-interventional Study

Terminated

• Conditions: Advanced Renal Cell Carcinoma (All Subtypes); Metastatic Renal Cell Carcinoma (All Subtypes)

• Registration Number: NCT04147143
• Lead Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-08
• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-30
• Study First Posted: 2019-10-31
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-21
• Last Update Posted: 2022-12-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 56

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
number of dose reductions	through study completion, an average of 1 year	number of dose reductions
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
number of dose interruptions	through study completion, an average of 1 year	number of dose interruptions
ORR	through study completion, an average of 1 year	ORR (investigator assessed; acc. RECIST v1.1 if available)
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
Clinical benefit rate (CBR)	through study completion, an average of 1 year	Clinical benefit rate (CBR)
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)
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

Trial Locations

Locations (2)

Uniklinik Münster; 🇩🇪 Münster, Nordrhein-Westfalen, Germany

Uniklinik Essen; 🇩🇪 Essen, Nordrhein-Westfalen, Germany