TY - JOUR
T1 - 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)
AU - Bex, Axel
AU - Van Thienen, Johan V.
AU - Schrier, Mariette
AU - Graafland, Niels
AU - Kuusk, Teele
AU - Hendricksen, Kees
AU - Lagerveld, Brunolf
AU - Zondervan, Patricia
AU - van Moorselaar, Jeroen R. A.
AU - Blank, Christian
AU - Wilgenbos, Sofie
AU - Haanen, John
PY - 2019/7/1
Y1 - 2019/7/1
N2 - 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).
AB - 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).
KW - Phase II
KW - avelumab
KW - axitinib
KW - neoadjuvant
KW - renal cancer
UR - http://www.scopus.com/inward/record.url?scp=85069500118&partnerID=8YFLogxK
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85069500118&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/31023100
U2 - https://doi.org/10.2217/fon-2019-0111
DO - https://doi.org/10.2217/fon-2019-0111
M3 - Article
C2 - 31023100
SN - 1479-6694
VL - 15
SP - 2203
EP - 2209
JO - Future oncology
JF - Future oncology
IS - 19
ER -