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Article History

Received: 31 December 2018

Revised: 14 August 2019

Accepted: 4 March 2020

First Online: 2 April 2020

Ethics approval and consent to participate

: The study followed the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. Patients were enrolled with approval from ethics committees and institutional review boards at participating institutions (UT Health Science Center, San Antonio, TX; UT Southwestern Medical Center, Dallas, TX; Scottsdale Healthcare Research Institute, Scottsdale, AZ; Mayo Clinic Cancer Center, Scottsdale, AZ; UT MD Anderson Cancer Center, Houston, TX; Asan Medical Center, Seoul, Korea; Samsung Medical Center, Seoul, Republic of Korea; Seoul National University Hospital, Seoul, Republic of Korea; Severance Hospital, Seoul Korea, USO Dallas TX; SCRI Boulder, CO), and all patients provided written informed consent before starting study-specific procedures.

: All patients provided written, informed consent.

: The datasets generated and/or analysed during the current study are not publicly available due proprietary restrictions but are available from the corresponding author on reasonable request.

: D.S.H. Research/Grant Funding: AbbVie, Adaptimmune, Amgen, Astra-Zeneca, Bayer, BMS, Daiichi-Sankyo, Eisai, Fate Therapeutics, Genentech, Genmab, Ignyta, Infinity, Kite, Kyowa, Lilly, LOXO, Merck, MedImmune, Mirati, MiRNA, Molecular Templates, Mologen, NCI-CTEP, Novartis, Pfizer, Seattle Genetics, Takeda Travel, Accommodations, Expenses: LOXO, MiRNA; Consulting or advisory role: Alpha Insights, Axiom, Adaptimmune, Baxter, Bayer (Ad Board and Speakers Bureau), Genentech, GLG, Group H, Guidepoint Global, Infinity, Janssen, Merrimack, Medscape, Numab, Pfizer, Seattle Genetics, Takeda, Trieza Therapeutics other ownership interests: Molecular Match (Advisor), OncoResponse (founder), Presagia Inc (Advisor). Y.-K.K. consulting or advisory role: Lilly/ImClone; Novartis; Ono Pharmaceutical; Roche/ Genentech; Taiho Pharmaceutical; research funding: Bayer; Novartis; Roche/Genentech. J.Sa. Honoraria: Celgene; consulting or Advisory Role: Celgene. A.B. Honoraria: Vascular Biogenics; Consulting or Advisory Role: NanoTX; Teleflex Medical Research Funding: Mirna Therapeutics (Inst); Threshold Pharmaceuticals; Patents, Royalties, other intellectual property: NanoTx Pharmaceuticals; travel, accommodations, expenses: Vascular Biogenics. G.F. Royalties: Wolters Kluwer; Advisory role: EMD Serono; Travel: Bristol-Myers Squibb, EMD Serono, Millennium; Research funding: 3-V Biosciences, Abbvie, Aileron, American Society of Clinical Oncology, Amgen, ARMO, AstraZeneca, BeiGene, Biothera, Celldex, Celgene, Ciclomed, Curegenix, Curis, DelMar, eFFECTOR, Eli Lilly, EMD Serono, Fujifilm, Genmab, GlaxoSmithKline, Hutchison MediPharma, Ignyta, Incyte, Jacobio, Jounce, Kolltan, Loxo, MedImmune, Millennium, Merck, miRNA Therapeutics, National Institutes of Health, Novartis, OncoMed, Oncothyreon, Precision Oncology, Regeneron, Rgenix, Strategia, Syndax, Taiho, Takeda, Tarveda, Tesaro, Tocagen, U.T. MD Anderson Cancer Center, Vegenics. A.G.B. employment: Mirna Therapeutics; stock and other ownership interests: Mirna Therapeutics Patents, royalties, other intellectual property: inventor on patents and patent applications assigned to Mirna Therapeutics. J.St. employment: Mirna Therapeutics; stock and other ownership interests: Mirna Therapeutics. S.S. employment: Mirna Therapeutics; stock and other ownership interests: Mirna Therapeutics. S.K. employment: Mirna Therapeutics; Leadership: Mirna Therapeutics; stock and other ownership interests: Mirna Therapeutics; Pfizer; Patents, Royalties, other intellectual property: listed as an inventor on patent applications, but no ownership interest or royalties. M.S.B. consulting or advisory role: Bayer; Celgene; Ipsen; Research funding: Celgene; Mirna Therapeutics; Precision Biologics; Travel, Accommodations, Expenses: Mirna Therapeutics; Precision Biologics. The remaining authors declare no competing interests.

: Funded by Mirna Therapeutics, Inc.; The University of Texas MD Anderson Cancer Center is supported in part by the National Institutes of Health through Cancer Center Support Grant P30CA016672.