A Phase II, single-arm trial of neoadjuvant axitinib plus avelumab in patients with localized renal cell carcinoma who are at high risk of relapse after nephrectomy (NEOAVAX)

Axel Bex*, Johan V. Van Thienen, Mariette Schrier, Niels Graafland, Teele Kuusk, Kees Hendricksen, Brunolf Lagerveld, Patricia Zondervan, Jeroen R. A. van Moorselaar, Christian Blank, Sofie Wilgenbos, John Haanen

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


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).

Original languageEnglish
Pages (from-to)2203-2209
Number of pages7
JournalFuture Oncology
Issue number19
Publication statusPublished - 1 Jul 2019

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