Clinical trial NCT06548867: Retrospective Analysis of Patients With Metastatic Renal Cell Carcinoma Treated With CABOzantinib
Official title: Retrospective Analysis of Patients With Metastatic Renal Cell Carcinoma Treated With CABOzantinib: a GENomic Signature for Describing Long-lasting Response
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Renal Cell Carcinoma
Keywords: Metastatic Renal Cell Carcinoma
Genomic signature
long lasting response
cabozantinib treatment
Lead sponsor: Gruppo Oncologico Italiano di Ricerca Clinica
Sponsor class: OTHER
Collaborators: name: Yghea
name: Ipsen
First posted: 2024-08-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with metastatic clear cell renal carcinoma (mRCC) who are long-lasting responders to treatment with cabozantinib and patients who are not long-lasting responders to the cabozantinib treatment. Cabozantinib treatment receive after one or more previuos therapy for mRCC

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.

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.

Primary outcomes:
measure: Genomic profiling
timeFrame: 12 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 12 months
measure: Overall response rate (ORR)
timeFrame: 12 months
measure: Duration of response (DOR)
timeFrame: 12 months
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: AUSL-IRCCS of Reggio Emilia
Study officials:
affiliation: AUSL/IRCCS of Reggio Emilia
name: Carmine Pinto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AUSL/IRCCS of Reggio Emilia
name: Cristina Masini, MD
role: STUDY_CHAIR
affiliation: AUSL/IRCCS of Reggio Emilia
name: Stefania Di Girolamo, MD
role: STUDY_CHAIR
References: