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

Recruiting

• Conditions: Metastatic Renal Cell Carcinoma
• Interventions: Drug: Cabozantinib

• Registration Number: NCT06548867
• Lead Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica

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.

Study Timeline

• Study Start: 2024-05-28
• Status Verified: 2024-08
• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-08
• Last Update Submitted: 2024-08-08
• Study First Posted: 2024-08-12
• Last Update Posted: 2024-08-12
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A: long-lasting responders	Cabozantinib	Patient long-lasting responders (PFS ≥9 months) to cabozantinib
Group B: primary refractories	Cabozantinib	Patient progressed from the start to cabozantinib therapy within 3 months

Primary Outcome Measures

Name	Time	Method
Genomic profiling	12 months	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)

Secondary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	12 months	to describe ORR according to the detected genomic profiling
Overall Survival (OS)	12 months	to describe OS based according to detected genomic profiling
Duration of response (DOR)	12 months	to describe duration of response (DOR) according to the detected genomic profilingto describe the genomic profiling according to treatment line (second, third or subsequent) to describe anamnestic characteristics (weight, ECOG PS, sites of metastasis, response to previous treatment lines)

Trial Locations

Locations (1)

AUSL-IRCCS of Reggio Emilia; 🇮🇹 Reggio Emilia, Italy