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
This study looks at how well cabozantinib works for people with advanced kidney cancer who have already tried other treatments, to see if certain genetic changes affect their response to the drug.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gruppo Oncologico Italiano di Ricerca Clinica Academic / other |
| Drugs / interventions | cabozantinib |
| Locations | 1 site (Reggio Emilia) |
| Trial ID | NCT06548867 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze patients with metastatic clear cell renal carcinoma who have been treated with cabozantinib after prior therapies. It will enroll approximately 80 patients across 10 centers in Italy, categorizing them into long-lasting responders and primary refractories based on their progression-free survival. Genomic profiling will be conducted on tissue samples to identify genetic alterations associated with treatment response. The study seeks to enhance understanding of the genomic factors influencing treatment outcomes in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults with a histological diagnosis of predominantly clear cell carcinoma who have previously received treatment for metastatic renal cell carcinoma.
Not a fit: Patients without available tumor tissue for genomic profiling or those who progressed between 3 and 9 months on cabozantinib may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved personalized treatment strategies for patients with metastatic renal cell carcinoma.
How similar studies have performed: Other studies have shown promise in genomic profiling for treatment response in cancer, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Reggio Emilia
- AUSL-IRCCS of Reggio Emilia — Reggio Emilia, Italy (Recruiting)
Study contacts
- Principal investigator: Carmine Pinto, MD — AUSL/IRCCS of Reggio Emilia
- Study coordinator: Carmine Pinto, MD
- Email: carmine.pinto@ausl.re.it
- Phone: +39 0522296614
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.