MR: none, YW: none, SC: none, HP: none, SG: none, LCH: reports previous employment at Dana-Farber Cancer Institute and grants to institution from Bayer, Sotio, Bristol-Myers Squib, Merck, Takeda, Dendreon/Valient, Jannsen, Medivation/Astellas, Genentech, Pfizer, and Endocyte (Novartis), Advisory or consulting services for Bayer, Genentech, Pfizer, Medivation/Astellas, Corvus, Merck, Exelixis, Novartis, Advanced Accelerator Applications, Jounce, Bristol-Myers Squibb, EMD Serrano, Michael J Hennessy Associates (Healthcare Communications Company and several brands such as OncLive and PER), ASIM CME, and Ology Medical Education during the conduct of the study, as well as current employment (including stock options) at Surface Oncology and travel support form Bayer and Genentech outside the submitted work. AP: Consulting: Seagen Inc and Astellas Pharma Inc. JK: none, MF: none, LG: none, ADC: Advisory Board: Clovis, Dendreon, Bayer, Eli Lilly, AstraZeneca, Astellas, Blue Earth, Janssen, Tolmar, Sanofi Aventis; Research Funding to Institution: Bayer, Pfizer; Honoraria for speaking engagement: Bayer, Pfizer, Lantheus, HJ: Research support: Blue Earth Diagnostics, Inc; Consulting: Advanced Accelerator Applications, Spectrum Dynamics; Royalties: Cambridge Publishing; Honoraria: Blue Earth Diagnostics, Inc., Munrol.

The trial was conducted in full concordance with Declaration of Helsinki principles and Good Clinical Practice and approved by the Dana-Farber Cancer Institute Institutional Review Board.