Journal article
Avelumab Combined with Stereotactic Ablative Body Radiotherapy in Metastatic Castration-resistant Prostate Cancer: The Phase 2 ICE-PAC Clinical Trial
EM Kwan, L Spain, A Anton, CL Gan, L Garrett, D Chang, E Liow, C Bennett, T Zheng, J Yu, C Dai, P Du, S Jia, H Fettke, C Abou-Seif, G Kothari, M Shaw, P Parente, C Pezaro, B Tran Show all
European Urology | ELSEVIER | Published : 2022
Abstract
Background: Immune checkpoint inhibitor monotherapy in metastatic castration-resistant prostate cancer (mCRPC) has produced modest results. High-dose radiotherapy may be synergistic with checkpoint inhibitors. Objective: To evaluate the efficacy and safety of the PD-L1 inhibitor avelumab with stereotactic ablative body radiotherapy (SABR) in mCRPC. Design, setting, and participants: From November 2017 to July 2019, this prospective phase 2 study enrolled 31 men with progressive mCRPC after at least one prior androgen receptor–directed therapy. Median follow-up was 18.0 mo. Intervention: Avelumab 10 mg/kg intravenously every 2 wk for 24 wk (12 cycles). A single fraction of SABR (20 Gy) was ad..
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Awarded by Pfizer
Funding Acknowledgements
Edmond M. Kwan is supported by an NHMRC postgraduate scholarship, a Monash University postgraduate publications award, and a Cancer Council Victoria postdoctoral fellowship. Arun A. Azad is supported by an NHMRC project grant (GNT1098647), a Victorian Cancer Agency clinical research fellowship (CRF14009), and an Astellas investigator-initiated grant. Avelumab and funding support for the study conduct were provided by Merck Healthcare Pty. Ltd., Australia, an affiliate of Merck KGaA (Darmstadt, Germany), as part of an alliance between Merck KGaA and Pfizer. Neither Merck KGaA nor Pfizer had a role in the design and conduct of the study, or the collection, management, analysis, and interpretation of the data. Merck KGaA and Pfizer reviewed the manuscript for medical accuracy only before journal submission. The authors are fully responsible for the content of this manuscript and the final decision to submit the manuscript for publication.