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

NCT ID: NCT06548867

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-28
• Study Completion Date: 2025-06-30

Brief 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.

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.

Conditions

Metastatic Renal Cell Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group A: long-lasting responders

Patient long-lasting responders (PFS ≥9 months) to cabozantinib

Cabozantinib

Intervention Type: DRUG

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

Group B: primary refractories

Patient progressed from the start to cabozantinib therapy within 3 months

Cabozantinib

Intervention Type: DRUG

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

Interventions

Cabozantinib

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yghea

UNKNOWN

Sponsor Role: collaborator

Ipsen

INDUSTRY

Sponsor Role: collaborator

Gruppo Oncologico Italiano di Ricerca Clinica

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmine Pinto, MD

Role: PRINCIPAL_INVESTIGATOR

AUSL/IRCCS of Reggio Emilia

Cristina Masini, MD

Role: STUDY_CHAIR

AUSL/IRCCS of Reggio Emilia

Stefania Di Girolamo, MD

Role: STUDY_CHAIR

AUSL/IRCCS of Reggio Emilia

Locations

AUSL-IRCCS of Reggio Emilia

Reggio Emilia, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Carmine Pinto, MD

Role: CONTACT

carmine.pinto@ausl.re.it

+39 0522296614

Facility Contacts

Carmine Pinto, MD

Role: primary

carmine.pinto@ausl.re.it

+39 0522296614

Other Identifiers

GOIRC-08-2018

Identifier Type: -

Identifier Source: org_study_id