Clinical trial · Observational
Retrospective Analysis of Patients With Metastatic Renal Cell Carcinoma Treated With CABOzantinib
Retrospective Analysis of Patients With Metastatic Renal Cell Carcinoma Treated With CABOzantinib: a GENomic Signature for Describing Long-lasting Response
NCT06548867CI-TRIAL-00079727CABOGENunknownClinicalTrials.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)
CABOGEN is a Observational, retrospective, multicenter study that will enroll patients with metastatic clear cell renal carcinoma (mccRCC) treated with cabozantinib after one or more previous lines of treatment that included TKIs, immune checkpoint inhibitors or mTOR inhibitors.
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 |
|---|---|---|---|
| Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabozantinib | Drug | Cabozantinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Group A: long-lasting responders
- description
- Patient long-lasting responders (PFS ≥9 months) to cabozantinib
- interventionNames
- Drug: Cabozantinib
- label
- Group B: primary refractories
- description
- Patient progressed from the start to cabozantinib therapy within 3 months
- interventionNames
- Drug: Cabozantinib
Primary outcomes (1)
- measure
- Genomic profiling
- timeFrame
- 12 months
- description
- to describe genomic profiling of patients with mRCC who are long-lasting responders (PFS ≥9 months) to cabozantinib and describe genomic profiling of patients with rapid disease progression following cabozntinib therapy (PFS≤ 3 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years. * Patients with histological diagnosis of predominantly clear cell carcinoma * Availability of the tumor tissue from the primary tumor and/or a metastatic site for the genomic profiling analysis not older than 5 years. * Evaluable disease according to RECIST criteria v 1.1 * Treatment with cabozantinib after one or more previous therapies for mRCC * Patient progressed from the start to cabozantinib therapy within 3 months or after 9 months * Any prognosis group according to the IMDC risk score * Signed informed consent must be obtained for living patients. Patients who died and patient untraceable will be analyzed based on the Authorization no. 9/2016 of the Italian Data Protector Supervisor. Exclusion Criteria: * Non-availability of tumor tissue from the primary tumor or a metastatic site for biomarker analysis * Patient progressed between 3 and 9 months from the beginning of treatment with cabozantinib. * Non-availability of clinical information useful to evaluate the IMDC risk group at baseline.
References
Publications (0)
Data not yet available
No reference posted for this study.