Abstract
TPS233 Background: Until recently, patients with metastatic renal cell carcinoma (mRCC) had few treatment options given the low response rate associated with chemotherapy and cytokine treatment. An improved understanding of the molecular basis of RCC has led to the development of targeted therapies that have shown clinical benefit in patients with metastatic disease. Everolimus is an oral inhibitor of the mammalian target of rapamycin (mTOR), a key regulator of cell growth and proliferation, cellular metabolism, and angiogenesis that is aberrantly activated in RCC. In the pivotal RECORD-1 study, everolimus monotherapy prolonged progression-free survival (PFS) vs placebo in patients with clear cell mRCC whose disease had progressed on vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapy, and everolimus is now approved for this indication. The EVERMORE (Everolimus as Monotherapy Treatment for Patients with Metastatic Recurrent and/or Unresectable Renal Cell Carcinoma) trial will evaluate the efficacy and safety of everolimus monotherapy in patients with metastatic recurrent and/or unresectable RCC without prior systemic therapy other than cytokine therapy. Methods: EVERMORE is an open-label, multicenter, single-arm phase II trial. Up to 80 adult patients with metastatic, recurrent, or unresectable RCC of any MSKCC prognosis and histologic or cytologic confirmation of clear cell or non-clear cell RCC, ≥1 measurable baseline lesion as per RECIST criteria, Karnofsky performance status ≥70%, and adequate liver, renal, and bone marrow function are targeted for enrollment. Patients who have received prior systemic RCC therapy (sunitinib, sorafenib, bevacizumab, sirolimus, temsirolimus, everolimus, deferolimus) other than cytokine therapy are excluded. Everolimus 10 mg/d will be administered orally until disease progression, unacceptable toxicity, or study discontinuation for any other reason. The primary study endpoint is PFS. Overall survival, disease control rate, objective response rate and duration, and safety will also be assessed. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Novartis Novartis
Published Version
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