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Recruiting NCT06548867

Retrospective Analysis of Patients With Metastatic Renal Cell Carcinoma Treated With CABOzantinib

— Observational Metastatic Renal Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cabozantinib.
Who it may be relevant to
Registry conditions: Metastatic Renal Cell Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Retrospective Analysis of Patients With Metastatic Renal Cell Carcinoma Treated With CABOzantinib: a GENomic Signature for Describing Long-lasting Response

Overview

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.

Detailed description

The aim of this study is to describe the genomic profiling of patients with metastatic renal cell carcinoma (mRCC) who are long-lasting responders to treatment with cabozantinib and patients who are not long-lasting responders to the cabozantinib treatment.

The study plan to enroll about 80 patients in 10 Italian centers:

Group A: 40 patients defined as long-lasting responders (PFS ≥ 9 months) Group B: 40 patients defined as primary refractories to cabozantinib (PFS ≤ 3 months)

Tissue samples from nephrectomy or from a metastatic site will be used to perform genomic profiling not older than 5 years.Tissue should be formalin-fixed, paraffin-embedded (FFPE).

Genomic profiling will be performed with a hybrid capture-based next-generation sequencing assay (FoundationONE). The sample will be assayed for all coding exons of 324 cancer-related genes plus select introns from 34 genes that are frequently rearranged in cancer. Sequencing will be performed to a mean exon coverage depth of \>500X. The resulting sequences will be analyzed for all classes of genomic alteration, including short variant alterations, copy number alterations, and selected gene fusions or rearrangements.

Interventions

  • Drug Cabozantinib
    Patients must have been treated with cabozantinib after one or more previous therapies for mRCC, as per clinical practise.

Primary outcome measures

  • Genomic profiling [Time frame: 12 months]
Secondary outcome measures (3)
  • Overall Survival (OS) [Time frame: 12 months]
  • Overall response rate (ORR) [Time frame: 12 months]
  • Duration of response (DOR) [Time frame: 12 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • AUSL-IRCCS of Reggio Emilia — Reggio Emilia

Identifiers

NCT: NCT06548867 · GOIRC-08-2018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗