A Comparison of Blood and Tissue Biomarkers Before and After Nephrectomy in the First-line Setting With Everolimus in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
An open-label, exploratory, single-arm, multicenter trial. Treatment with everolimus will be
initiated once patients have undergone baseline screening and provided their written
Everolimus will be administered orally, once daily, for 6 weeks followed by a 1-week rest
period prior to surgery. The starting dose will be 10 mg daily with provision for dose
reduction based on tolerability.
Radical nephrectomy will be performed at the end of week 7. For metastatic patients, two to
four weeks after surgery, everolimus will be reintroduced. Treatment will be continued until
disease progression, unacceptable toxicity, withdrawal of patient consent, or other stopping
rules are met.
Patients with locally advanced renal carcinoma will stop drug intake before nephrectomy.
Resumption of everolimus may be postponed in cases of a delay in wound healing or surgical
After treatment discontinuation and the last treatment visit (28-days after the last dose),
patients will be followed up in order to collect data on the onset of progression and
survival. In metastatic patients discontinuing treatment for reasons other than disease
progression, tumor assessment will continue every 3 months, until disease progression or
initiation of other anticancer therapy for up to one year of follow-up.
Intervention Model: Single Group Assignment, Masking: Open Label
Objective clinical benefit
Objective clinical benefit is defined as complete response, partial response or stable disease according to RECIST criteria version 1.1
After 6 weeks of treatment
Stéphane Oudard, MD, PhD
Hôpital Européen Georges Pompidou, Paris (France)
France: Agence Nationale de Sécurité du Médicament et des produits de santé