Clinical trial NCT04147143: CaboCHECK - Cabozantinib in Adult Patients With Advanced Renal Cell Carcinoma Following Prior Systemic Check Point Inhibition Therapy: a Retrospective, Non-interventional Study
Official title: Cabozantinib in Adult Patients With Advanced Renal Cell Carcinoma Following Prior Systemic Check Point Inhibition Therapy: a Retrospective, Non-interventional Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Advanced Renal Cell Carcinoma (All Subtypes)
Metastatic Renal Cell Carcinoma (All Subtypes)
Lead sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Incidence of serious adverse events
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: number of dose reductions
timeFrame: through study completion, an average of 1 year
measure: number of dose interruptions
timeFrame: through study completion, an average of 1 year
measure: number of terminations of cabozantinib treatment due to adverse events
timeFrame: through study completion, an average of 1 year
measure: ORR
timeFrame: through study completion, an average of 1 year
measure: Clinical benefit rate (CBR)
timeFrame: through study completion, an average of 1 year
measure: Duration of response
timeFrame: through study completion, an average of 1 year
measure: Duration of cabozantinib treatment
timeFrame: through study completion, an average of 1 year
measure: Time to next treatment
timeFrame: From date of last dose of cabozantinib until the date of first dose of next treatment, assessed up to 100 months
measure: Safety in IO-cabozantinib-sequence compared to cabozantinib single agent therapy historical data
timeFrame: through study completion, an average of 1 year
measure: Comparison of effectiveness endpoints of IO-cabozantinib-sequence to historical efficacy data (ORR, CBR)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Uniklinik Essen
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Uniklinik Münster
state: Nordrhein-Westfalen
Study officials:
affiliation: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
name: Salah-Eddin Al-Batran, Prof. Dr.
role: STUDY_DIRECTOR
References: