Clinical trial · Interventional
Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma
Cabozantinib and Nivolumab Among Older Patients With Renal-cell Carcinoma, a Prospective Cohort With Geriatric, Pharmacologic and Patient-reported-outcome Evaluation
NCT06934057CI-TRIAL-00095696CABOLDrecruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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 goal of the study is to describe real-life use and exposition to nivolumab-cabozantinib among older patients with metastatic clear-cell renal cell cancer
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 |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabozantinib | Drug | Cabozantinib | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cabozantinib-Nivolumab
- description
- The patient will be treated according to standard of care Nivolumab Cabozantinib.
- interventionNames
- Drug: Nivolumab
- Drug: Cabozantinib
Primary outcomes (3)
- measure
- Starting dose of Cabozantinib
- timeFrame
- 24 weeks after treatment start
- description
- Primary outcome measure is treatment patterns, which includes starting dose of cabozantinib.
- measure
- Dose interruption of Cabozantinib
- timeFrame
- 24 weeks after treatment start
- description
- Primary outcome measure is treatment patterns of Cabozantinib, which includes the proportion of patients who experience any temporary dose interruption within the first 24 weeks of treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients ≥ 70 years-old 2. Confirmed advanced or metastatic renal-cell carcinoma 3. Patients not previously treated in metastatic setting 4. Performance Status 0 to 2 5. Sexually active male patients must agree to use condom during the study and for at least 5 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception. 6. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol. 7. Patients must be affiliated to a social security system or beneficiary of the same Exclusion Criteria: 1. Participation in another clinical study with an investigational product during the last four weeks and while on study treatment (Patients may be included in CABOLD if they are included in the arm B of CARE1 study EUCT N° 2023-503317-29-00) 2. Performance Status \> 2 3. Any condition that represent a contraindication to Cabozantinib and/or Nivolumab, as described in summaries of products characteristics, including symptomatic untreated brain metastasis or active auto-immune disease requiring systemic immunosuppressant/modulator (thyroid or adrenal disorder are not an exclusion criteria) 4. Any severe cardiovascular or thrombo-embolic event in the last three months 5. Any situation for which exclusive palliative care intervention is recommended 6. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
References
Publications (0)
Data not yet available
No reference posted for this study.