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. (CABOCARE)

• ClinicalTrials.gov Identifier: NCT03647878
• Recruitment Status: Recruiting
• First Posted: August 27, 2018
• Last Update Posted: March 7, 2023
• Sponsor: Ipsen
• Information provided by (Responsible Party): Ipsen

Tracking Information

• First Submitted Date: July 25, 2018
• First Posted Date: August 27, 2018
• Last Update Posted Date: March 7, 2023
• Actual Study Start Date: September 24, 2018
• Estimated Primary Completion Date: August 31, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 24, 2018)

• The proportion of subjects with dose reduction due to Serious Adverse Events/Adverse Events (SAEs/AEs) [ Time Frame: 2 years ]
  The proportion of subjects with ≥1 dose reduction due to AE will be described with its 95% confidence interval, by risk group and overall.
• The proportion of subjects with dose interruption due to SAEs/AEs [ Time Frame: 2 years ]
  The proportion of subjects with ≥1 dose interruption due to AE will be described with its 95% confidence interval, by risk group and overall.
• The proportion of subjects with termination of Cabozantinib due to SAEs/AEs [ Time Frame: 2 years ]
  The proportion of subjects with ≥1 discontinuation due to AE will be described with its 95% confidence interval, by risk group and overall.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 24, 2018)

• Progression free survival (PFS) [ Time Frame: 2 years ]
  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.
• Best overall response - Overall Response Rate (ORR) [ Time Frame: 2 years ]
  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.
• Best overall response - Disease Control Rate (DCR) [ Time Frame: 2 years ]
  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.
• All non-serious and serious adverse events (AEs / SAEs) and fatal outcomes [ Time Frame: 2 years ]
  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.
• Impact of the activity level at baseline on the occurrence of adverse events (AEs) [ Time Frame: 2 years ]
  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.
• The proportion of subjects with termination due to SAEs/AEs in sub-group [ Time Frame: 2 year ]
  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).
• The proportion of subjects with dose interruption due to SAEs/AEs in sub-group [ Time Frame: 2 year ]
  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).
• The proportion of subjects with dose reduction due to SAEs/AEs in sub-group [ Time Frame: 2 years ]
  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).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.
• Official Title: Prospective Non-interventional 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
• Brief Summary: The purpose of the protocol, is to describe the use of CabometyxTM (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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients treated with Cabozantinib as monotherapy or in combination with nivolumab in advanced or metastatic renal cell carcinoma in 1st line treatment
• Condition: Advanced or Metastatic Renal Cell Carcinoma
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 24, 2018): 105
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 31, 2026
• Estimated Primary Completion Date: August 31, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Ipsen Recruitment Enquiries; see email address; clinical.trials@ipsen.com

• Listed Location Countries: Austria, Germany

Administrative Information

• NCT Number: NCT03647878
• Other Study ID Numbers: A-DE-60000-009
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

• Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
• Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
• URL: https://vivli.org/members/ourmembers/

• Current Responsible Party: Ipsen
• Original Responsible Party: Same as current
• Current Study Sponsor: Ipsen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Ipsen Medical Director; Ipsen

• PRS Account: Ipsen
• Verification Date: March 2023