De Jesus-Acosta, Ana
Sugar, Elizabeth A.
O’Dwyer, Peter J.
Ramanathan, Ramesh K.
Von Hoff, Daniel D.
Rasheed, Zeshaan
Zheng, Lei
Begum, Asma
Anders, Robert
Maitra, Anirban
McAllister, Florencia
Rajeshkumar, N. V.
Yabuuchi, Shinichi
de Wilde, Roeland F.
Batukbhai, Bhavina
Sahin, Ismet
Laheru, Daniel A.
Funding for this research was provided by:
EIF | Stand Up To Cancer
Skip Viragh Foundation
Lustgarten Foundation
Article History
Received: 5 February 2019
Revised: 12 November 2019
Accepted: 28 November 2019
First Online: 20 December 2019
Ethics approval and consent to participate
: This study was approved by the Institutional Review Boards at each institution and all participants provided signed informed consent. This study was conducted in accordance with the Declaration of Helsinki for Good Clinical Practice guidelines. Institutional committees for study approval: (1) The Johns Hopkins Office of Human Subjects Research—Institutional Review Board. IRB #—NA_00036883. (2) University of Pennsylvania Office of Regulatory Affairs Institutional Review Board. IRB Protocol #812376. (3) TGEN: Western Institutional Review Board (WIRB). WIRB #s—(WIRB study #1119721) (WIRB Protocol #20101299).
: All authors have agreed and consented for publication.
: The data are available at Johns Hopkins’ secured system and as needed per request.
: A.D.J.A.—consulting: Merck; clinical trials grant support: Merck, AstraZeneca. P.J.O.—consulting: Genentech; clinical trials grant support: Genentech. L.Z.—consulting: NovaRock Biological, Datareve; research grant: Halozyme, iTeos, BMS, Merck, Amgen and NovaRock Biological; advisory board: Biosynergics, Alphamab, Mingrui and Foundation Medicine; shareholder: Mingrui; Aduro: under a licencing agreement between Aduro BioTech, Inc. and the Johns Hopkins University, the university and investigators are entitled to milestone payments and royalty on sales of the vaccine products. L.Z. had declined personal royalty. Z.R.: full-time employee of AstraZeneca. Remaining authors have no competing interests.
: The study was sponsored by a Stand Up to Cancer Dream Team Translational Cancer Research Grant (SU2C grant AACR-DT0509), Viragh Clinical Cancer Research and the Lustgarten Foundation. Genentech provided drug support.