| Autor: |
Bex A; Department of Urology, Netherlands Cancer Institute, Amsterdam, The Netherlands.; Department of Urology, Specialist Centre for Kidney Cancer, Royal Free London NHS Foundation Trust, London, UK.; Department of Urology, UCL Division of Surgery & Interventional Science, London, UK., van Thienen JV; Department of Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands., Schrier M; Department of Urology, Netherlands Cancer Institute, Amsterdam, The Netherlands.; Department of Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands., Graafland N; Department of Urology, Netherlands Cancer Institute, Amsterdam, The Netherlands., Kuusk T; Department of Urology, Netherlands Cancer Institute, Amsterdam, The Netherlands., Hendricksen K; Department of Urology, Netherlands Cancer Institute, Amsterdam, The Netherlands., Lagerveld B; Department of Urology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands., Zondervan P; Department of Urology, Amsterdam University Medical Center, Amsterdam, The Netherlands., van Moorselaar JA; Department of Urology, Amsterdam University Medical Center, Amsterdam, The Netherlands., Blank C; Department of Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands., Wilgenhof S; Department of Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands., Haanen J; Department of Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands. |
| Abstrakt: |
Surgery is the standard treatment for nonmetastatic renal cell carcinoma. Despite curative intent, patients with a high risk of relapse have a 5-year metastasis-free survival rate of only 30% and prevention of recurrence is an unmet need. In a Phase III trial (JAVELIN Renal 101), progression-free survival of axitinib + avelumab was superior to sunitinib with a favorable objective response rate and no added toxicity profiles as known for axitinib or avelumab single agent. NEOAVAX is designed as open label, single arm, Phase II trial with a Simon's two-stage design evaluating neoadjuvant axitinib + avelumab followed by complete surgical resection in 40 patients with high-risk nonmetastatic clear-cell renal cell carcinoma. Primary end point is remission of the primary tumor (RECIST 1.1; Response Evaluation Criteria In Solid Tumors) following neoadjuvant therapy. Secondary end points include disease-free survival, overall survival, rate of metastasis and local recurrence, safety, and tolerability. Exploratory end points include investigation of effects on neoangiogenesis, immune infiltrates and myeloid-derived suppressor cell components to support a rationale for the combined use of axitinib and avelumab (NCT03341845). |
