Study of Cabozantinib as Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment.

N/AActive Not RecruitingNCT03647878

Ipsen224 enrolled

Overview

The purpose of the protocol, is to describe the use of cabozantinib tablets as monotherapy or in combination with nivolumab including the number of dose reductions, dose interruptions and terminations due to (serious) adverse events in subjects with advanced or metastatic renal cell carcinoma (mRCC) treated in real-life clinical setting in 1st line treatment.

Study Type

OBSERVATIONAL

Enrollment

224

Conditions

Advanced Renal Cell Carcinoma Metastatic Renal Cell Carcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males or females aged 18 years and older with capacity to consent. * Subjects receiving cabozantinib as monotherapy or in combination with nivolumab as a first line treatment for advanced or metastatic renal cell carcinoma * Subjects with the intention to be treated with cabozantinib tablets as monotherapy or in combination with nivolumab according to the current local Summary of Product Characteristics (SmPC); decision has to be taken before entry in the study. * Signed written informed consent Exclusion Criteria: * Participation in an interventional study at the same time and/or within 3 months before baseline. * Previous participation in this study

Locations (82)

Landeskrankenhaus Hochsteiermark

Leoben, Austria

Kepler Universitätsklinikum GmbH

Linz, Austria

Uniklinikum Salzburg

Salzburg, Austria

Salzkammergutklinikum Vöcklabruck

Vöcklabruck, Austria

Klinikum Wels-Grieskirchen GmbH

Wels, Austria

Universitätsklinikum Aachen

Aachen, Germany

Urologisches Zentrum Euregio

Aachen, Germany

Onkologie aschaffenburg

Aschaffenburg, Germany

Universitätsklinikum Augsburg A.ö.R

Augsburg, Germany

MVZ Taunus GmbH

Bad Homburg, Germany

...and 72 more locations

Outcomes

Primary Outcomes

The proportion of subjects with dose reduction of cabozantinib due to Serious Adverse Events/Adverse Events (SAEs/AEs)

The proportion of subjects with ≥1 dose reduction due to AE will be described with its 95% confidence interval, by risk group and overall.

Time frame: 2 years

The proportion of subjects with dose interruption of cabozantinib and/or nivolumab due to SAEs/AEs

The proportion of subjects with ≥1 dose interruption due to AE will be described with its 95% confidence interval, by risk group and overall.

Time frame: 2 years

The proportion of subjects with termination of cabozantinib /cabozantinib-nivolumab combination due to SAEs/AEs

The proportion of subjects with ≥1 discontinuation due to AE will be described with its 95% confidence interval, by risk group and overall.

Time frame: 2 years

Number of injection delayed of nivolumab due to SAE/AE

Time frame: 2 years

Secondary Outcomes

Progression free survival (PFS)

Progression free survival is defined as the time between the start date of cabozantinib and the date of progression or death from any cause. Disease progression is defined as either radiological progression assessed by the investigator using RECIST 1.1 or clinical progression.

Time frame: 2 years

Best overall response - Overall Response Rate (ORR)

The best overall response is the best response assessed by investigator recorded during the treatment period. ORR is defined as the proportion of subjects achieving complete or partial response.

Time frame: 2 years

Best overall response - Disease Control Rate (DCR)

The best overall response is the best response assessed by investigator recorded during the treatment period. DCR is defined as the proportion of subjects achieving a complete response, partial response or stable disease.

Time frame: 2 years

All non-serious and serious adverse events (AEs / SAEs) and fatal outcomes

Safety: clinical parameter, as routinely assessed by the investigator, as well as occurrence of all serious and non-serious AEs as well as fatal outcomes and special situations. The adverse events will be described overall and also according to level of physical activity assessed by questionnaire and actigraph.

Time frame: 2 years

Impact of the activity level at baseline on the occurrence of adverse events (AEs)

Safety: clinical parameter, as routinely assessed by the investigator, as well as occurrence of all serious and non-serious AEs as well as fatal outcomes and special situations; data of activity level and quality of life will be collected using the quality of life questionnaire (NFKSI-19 questionnaire) and the activity questionnaire; inflammatory blood markers, as routinely assessed by the investigator, will be captured.

Time frame: 2 years

The proportion of subjects with termination due to SAEs/AEs in sub-group

The proportion of subjects with ≥1 termination due to AE will be described with its 95% confidence interval, by risk group and overall split by histological subtype (clear cell and non-clear cell).

Time frame: 2 year

The proportion of subjects with dose interruption due to SAEs/AEs in sub-group

The proportion of subjects with ≥1 dose interruption due to AE will be described with its 95% confidence interval, by risk group and overall split by histological subtype (clear cell and non-clear cell).

Time frame: 2 year

The proportion of subjects with dose reduction due to SAEs/AEs in sub-group

The proportion of subjects with ≥1 dose reduction due to AE will be described with its 95% confidence interval, by risk group and overall split by histological subtype (clear cell and non-clear cell).

Time frame: 2 years