Observational Real-life Study of Cabozantinib in Monotherapy or in Combination With Nivolumab in Advanced Renal Cell Carcinoma (RCC)
- Conditions
- Advanced or Metastatic Renal Cell Carcinoma
- Registration Number
- NCT04106349
- Lead Sponsor
- Ipsen
- Brief Summary
The purpose of this study is to describe the real-life use of Cabometyx® in monotherapy or in combination with nivolumab in Belgium in patients with advanced or metastatic Renal Cell Carcinoma (1st, 2nd and later lines of treatment)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Males or females aged 18 years and older
- Patients scheduled to receive Cabometyx® in monotherapy or in combination with nivolumabfor advanced or metastatic renal cell carcinoma
- Decision to treat patients with Cabometyx® in monotherapy or in combination with nivolumab has to be taken prior to and independent from participation in the clinical study
- Provision of written informed consent
- Participation in another interventional clinical study at the same time
- Previous participation in this clinical study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment discontinuations and reason From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop Number of patients with permanent discontinuation and reason
Dose reductions and reasons From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop Number of dose reductions and reason
Treatment interruptions and reason From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop Number of treatment interruptions and reason
Treatment line Baseline Treatment line will be assessed at baseline. It is a percentage of patients receiving cabozantinib as 1st, 2nd or later lines of treatment or cabozantinib in monotherapy or in combination with nivolumab as 1st line of treatment.
Median time to any first dose modification From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop Dose prescribed at initiation Baseline Number of patients with dose of 60 mg/day, 40 mg/day or 20 mg/day at baseline
Alternative dose schedule From baseline until the end of study up to 9 months Number of patients with schedules other than 1 pill at fixed dose/day for the total treatment period
Mean number of any dose modification From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop Median time to end of treatment From baseline until the end of study up to 9 months Median number of any dose modification From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop Duration of treatment exposure From baseline until the end of study up to 9 months Average daily dose From baseline until the end of study up to 9 months Estimation of average daily dose received by subject during the treatment exposure
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) From baseline until the end of study up to 9 months Radiological progression using RECIST 1.1 or investigator assessed or according to local standard of care or death; PFS evaluated at least every 12 weeks under treatment with cabozantinib
Objective Response Rate From baseline until the end of study up to 9 months Percent of patients with partial and complete response during the treatment with cabozantinib
Disease Control Rate From baseline until the end of study up to 9 months Percent of patients with stable disease, partial and complete response during the treatment with cabozantinib
Change in Quality of Life score From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop Changes in quality of life data by comparing changes in scores on Using the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NFKSI-19). It describes the severity, interference, and frequency rates.
Trial Locations
- Locations (25)
Chirec Delta
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Virga Jessa Ziekenhuis
🇧🇪Hasselt, Belgium
Hôpital de Jolimont
🇧🇪La Louvière, Belgium
CHC MontLegia
🇧🇪Liège, Belgium
Hôpital Ambroise-Paré Mons
🇧🇪Mons, Belgium
CHU Charleroi - site André Vésale
🇧🇪Montigny-le-Tilleul, Belgium
AZ Glorieux
🇧🇪Ronse, Belgium
CHWAPI
🇧🇪Tournai, Belgium
UCL Namur - site Godinne
🇧🇪Yvoir, Belgium
Onze-Lieve-vrouw Ziekenhuis Aalst
🇧🇪Aalst, Belgium
Imeldaziekenhuis
🇧🇪Bonheiden, Belgium
Vivalia Hôpital d'Arlon
🇧🇪Arlon, Belgium
AZ Sint-Jan Brugge
🇧🇪Brugge, Belgium
Clinique Saint-Luc Bouge
🇧🇪Bouge, Belgium
AZ Sint-Lucas
🇧🇪Brugge, Belgium
Hôpital Erasme
🇧🇪Brussels, Belgium
Ziekenhuis Oost-Limburg Genk
🇧🇪Genk, Belgium
CHR Citadelle Liège
🇧🇪Liège, Belgium
CHU Liège / Sart-Tilman
🇧🇪Liège, Belgium
Clinique Saint-Pierre
🇧🇪Ottignies, Belgium
AZ Delta
🇧🇪Roeselare, Belgium
AZ Turnhout
🇧🇪Turnhout, Belgium
CHR Verviers
🇧🇪Verviers, Belgium
UZ Brussel
🇧🇪Brussels, Belgium