Clinical trial · Observational
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.
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- The proportion of subjects with dose reduction of cabozantinib due to Serious Adverse Events/Adverse Events (SAEs/AEs)
- timeFrame
- 2 years
- description
- The proportion of subjects with ≥1 dose reduction due to AE will be described with its 95% confidence interval, by risk group and overall.
- measure
- The proportion of subjects with dose interruption of cabozantinib and/or nivolumab due to SAEs/AEs
- timeFrame
- 2 years
- description
- The proportion of subjects with ≥1 dose interruption due to AE will be described with its 95% confidence interval, by risk group and overall.
- measure
- The proportion of subjects with termination of cabozantinib /cabozantinib-nivolumab combination due to SAEs/AEs
- timeFrame
- 2 years
- description
- The proportion of subjects with ≥1 discontinuation due to AE will be described with its 95% confidence interval, by risk group and overall.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available