Shapiro, Geoffrey I. http://orcid.org/0000-0002-3331-4095
LoRusso, Patricia
Dowlati, Afshin
T. Do, Khanh
Jacobson, Caron A.
Vaishampayan, Ulka
Weise, Amy
Caimi, Paolo F.
Eder, Joseph Paul
French, Christopher A.
Labriola-Tompkins, Emily
Boisserie, Frédéric
Pierceall, William E.
Zhi, Jianguo
Passe, Sharon
DeMario, Mark
Kornacker, Martin
Armand, Philippe
Funding for this research was provided by:
Roche
Article History
Received: 24 April 2020
Revised: 19 October 2020
Accepted: 5 November 2020
First Online: 14 December 2020
Ethics approval and consent to participate
: This study was done in accordance with the International Conference on Harmonization for Good Clinical Practice and the Declaration of Helsinki. The study protocol was approved by institutional review boards at each study site (Western Institutional Review Board, Puyallup, WA; Dana-Faber Cancer Institute Institutional Review Board, Boston, MA; University Hospitals Institutional Review Board, Cleveland, OH). Written informed consent was obtained from all patients.
: All patients provided written informed consent prior to study initiation. Per the Informed Consent Form, this included consent for reporting or publication of data resulting from the study provided patients are not identified by name. No identifying patient details or images are used in this paper.
: Qualified researchers may request access to individual patient level data through the clinical study data request platform (ExternalRef removed). Further details on Roche's criteria for eligible studies are available here (ExternalRef removed). For further details on Roche’s Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (ExternalRef removed).
: All authors have received grants and non-financial or other support from F. Hoffmann-La Roche during the conduct of the study. Editorial support, funded by the sponsor, was provided by an independent medical writer under the guidance of the authors. G.I.S. has served on advisory boards for Roche, Lilly, Pfizer, Bicycle Pharmaceuticals, Merck/EMD Serono, Sierra Oncology, G1 Therapeutics, Fusion Pharmaceuticals, Cybrexa Therapeutics, Bayer, Ipsen, Astex and Almac and has received sponsored research funding from Lilly, Pfizer, Array BioPharma, Merck, Merck/EMD Serono and Sierra Oncology. P.L. has participated in data safety monitoring boards from Chiltern, Agios, Five Prime, Parexel, Halozyme, Novella Clinical and Tyme and in advisory boards from Alexion, Ariad, CytomX, Roche/Genentech, GenMab, Glenmark, Ignyta, Menarini, Novartis, Omniox and Takeda. K.T.D. has participated in advisory boards for QED Therapeutics and Seattle Genetics. C.A.J. has received honorarium or consulting fees from Kite Pharma, Precision Biosciences, Pfizer, Bayer, Novartis, Celgene and Humanigen. U.V. has received research grants from Bristol Myers Squibb, Astellas and Pfizer and personal fees from Bayer, Bristol Myers Squibb, Astellas and Pfizer. A.W. has participated in a speaker bureau and advisory board for Array BioPharma. P.F.C. has received research funding from Roche/Genentech and ADC Therapeutics and participated in speaker bureaus from Celgene and advisory boards for Kite Pharma, Genentech, and Fate Therapeutics. C.A.F. has received research grants from National Institutes of Health, GlaxoSmithKline, C4 Therapeutics, Curis and Constellation and personal fees from GlaxoSmithKline. E.L.-T. and M.D. were employees of Roche at the time of the study and have Roche stock. F.B., W.E.P., J.Z., and S.P. were employees of Roche at the time of the study. M.K. is an employee of Roche and has Roche stock. P.A. has consulted for Merck, Bristol Myers Squibb, Pfizer, Affimed, Adaptive, Infinity, ADC Therapeutics, Celgene, Morphosys, Daiichi Sankyo, Miltenyi, and Tessa and received institutional research funding from Merck, Bristol Myers Squibb, Affimed, Adaptive, Roche, Tensha, Otsuka, Sigma Tau, Genentech and IGM. The following authors have nothing additional to disclose beyond the support received for this work: A.D. and J.P.E.
: This work was funded by F. Hoffmann-La Roche, Ltd.