Clinical trial · Observational
A Study of the Effectiveness of Cabozantinib in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma (aRCC) in Adults
A Prospective Observational International Study of Cabozantinib Tablets in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma in Adults
- 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 this study is to collect data to describe the safety and effectiveness of cabozantinib and nivolumab in combination as a first-line treatment in adults with aRCC with clear cell-component, according to real-world clinical practice. The decision to prescribe cabozantinib and nivolumab in combination will be made prior to, and independently from, the decision to enrol the participant in study.
Conditions
Conditions (1)
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 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival (OS) rate (death of any cause) from the start of cabozantinib in combination with nivolumab.
- timeFrame
- At 18 months follow up
Secondary outcomes (11)
- measure
- Tumor median progression-free survival (PFS) time
- timeFrame
- Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression
- description
- Including clinical and radiographic assessments defined as the time between the start date of cabozantinib in combination with nivolumab and the date of progression or death of any cause. The Kaplan-Meier method will be used to estimate median PFS.
- measure
- Proportion of participants who achieve partial or complete response (Objective Response Rate (ORR))
- timeFrame
- Every month until month 4, and every 3 months after month 4 up to 42 month or disease progression
- description
- Assessed by the investigator
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with diagnosis of aRCC with clear-cell component * Participants with no prior systemic treatment for aRCC with clear-cell component; * Physician-initiated decision to treat with cabozantinib and nivolumab in combination (prior to study enrolment), according to Cabometyx® and Opdivo® approved local labels; Exclusion Criteria: * Current participation in an investigational program with any intervention which could possibly interfere the treatment and impact this study; * History of allergy or hypersensitivity to Cabometyx® or Opdivo® components.
References
Publications (1)
- DERIVEDBarthelemy P, Dutailly P, Qvick B, Perrot V, Verzoni E. CaboCombo: a prospective, phase IV study of first-line cabozantinib + nivolumab for advanced renal cell carcinoma. Future Oncol. 2024 Apr;20(13):811-819. doi: 10.2217/fon-2023-0353. Epub 2023 Jul 5. PMID 37403652