NCT01731158

Sequential Therapy in Metastatic Renal Cell Carinoma

A Prospective, Open-label, Multicenter, Randomized Phase II Trial: Sequential Therapy With BEvacizumab, RAd001 (Everolimus) and Tyrosinekinase Inhibitors (TKI) in Metastatic Renal Cell Carcinoma (mRCC) (BERAT Study)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Central European Society for Anticancer Drug Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Sequential therapy with BEvacizumab, RAd001 (everolimus) and Tyrosinekinase inhibitors (TKI) in metastatic renal cell carcinoma (mRCC)

Detailed description

This will be a prospective, open label, randomized multicenter phase-II study to evaluate progression free survival (PFS) in 2nd line treatment in patients with locally advanced or metastatic clear-cell renal cell cancer (cc-RCC) receiving everolimus (arm A) in comparison to a tyrosine-kinase inhibitor (TKI) (arm B). Following 2nd line treatment, patients will be switched to a TKI in arm A and everolimus in arm B. All patients will receive bevacizumab as standardized first-line treatment. Another key element of the study is the analysis of predictive biomarkers, which will be performed in serum and tumor tissue, respectively. Serum samples will be collected at prespecified timepoints throughout the study and analysed by SELDI-TOF-MS and DIGE. Candidate proteins are thought to predict therapeutic outcome and candidates are subject for target validation by Western Blot or ELISA. In addition, formalin-fixed paraffin-embedded (FFPE) tumor tissue will be collected prospectively and analysed for micro RNA (miRNA). Candidate miRNAs that predict therapeutic outcome will be validated by quantitative RT-PCR. Furthermore, circulating tumor cells (CTCs) will be generated from blood drawings during routine visits. The primary objective is to correlate the marker profile defined from the FFPE tissue with the profile obtained from CTCs in order to validate expression based markers ant their change during different treatment lines.

Conditions

• Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Avastin in combination with Roferon-A
DRUG	Afinitor
DRUG	TKI: Sutent, Nexavar or Votrient	TKI

Timeline

• Start date: 2012-10-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2012-11-21
• Last updated: 2019-02-06

Locations

13 sites across 1 country: Germany