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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Genomic profiling [Срок оценки: 12 months]

Вторичные конечные точки (3)

• Overall Survival (OS) [Срок оценки: 12 months]
• Overall response rate (ORR) [Срок оценки: 12 months]
• Duration of response (DOR) [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• AUSL-IRCCS of Reggio Emilia — Reggio Emilia

Идентификаторы

NCT: NCT06548867 · GOIRC-08-2018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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