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

Last updated: August 8, 2024
Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Treatment

Cabozantinib

Clinical Study ID

NCT06548867
GOIRC-08-2018
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 forthe 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 9months

  • Any prognosis group according to the IMDC risk score

  • Signed informed consent must be obtained for living patients. Patients who died andpatient untraceable will be analyzed based on the Authorization no. 9/2016 of theItalian Data Protector Supervisor.

Exclusion

Exclusion Criteria:

  • Non-availability of tumor tissue from the primary tumor or a metastatic site forbiomarker analysis

  • Patient progressed between 3 and 9 months from the beginning of treatment withcabozantinib.

  • Non-availability of clinical information useful to evaluate the IMDC risk group atbaseline.

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Cabozantinib
Phase:
Study Start date:
May 28, 2024
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • AUSL-IRCCS of Reggio Emilia

    Reggio Emilia, 42123
    Italy

    Active - Recruiting

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