Gemcitabine and cisplatin plus nivolumab as organ-sparing treatment for muscle-invasive bladder cancer: a phase 2 trial.

"data availability in accordance with nih's genomic data sharing policy the dna sequencing data used to support the findings of this study have been deposited under controlled access in the database of genotypes and phenotypes (dbgap) under accession number phs0003372."

"Competing interests M.D.G. has received research funding from Bristol Myers Squibb, Novartis, Dendreon, AstraZeneca, Merck and Genentech. He has served as a consultant to Bristol Myers Squibb, Merck, Genentech, AstraZeneca, Pfizer, EMD Serono, SeaGen, Janssen, Numab, Dragonfly, GlaxoSmithKline, Basilea, UroGen, Rappta Therapeutics, Alligator, Silverback, Fujifilm, Curis, Gilead, Bicycle, Asieris, Abbvie and Analog Devices. S.D. has served as a consultant to Janssen, Ferring, Photocure, Taris, Pacific Edge, QED, Abbvie, Janssen, Bristol Myers Squibb, Sesen, Protara, Pfizer and CG Oncology. T.B.D. has served as a consultant to Astellas, AstraZeneca, Bayer, Janssen and Sanofi. R.M. has served as a consultant to Bristol Myers Squibb, Roche, Astellas and Seattle Genetics and has received research funding from Merck and Astellas. C.K. has served as a consultant to Exelixis, Sanofi, AVEO, EMD Serono and Janssen and has received research funding from Sanofi, Gilead Sciences, AstraZeneca, ESSA Pharma, Pionyr and Incyte. He owns stock in Biogen and Epic Systems. T.J. is an employee of Genentech. A.H. has served as a consultant to HTG Molecular Diagnostics and Immunorizon. L.W. is an employee of GeneDx. K.W.M. has served as a consultant to EMD Serono, Pfizer, UroGen and Riva Therapeutics, has received research support from Pfizer and Novo Ventures, has equity in Riva Therapeutics, has received writing fees from UpToDate and has received speaking fees from OncLive. He is named on an institutional patent filed on mutational signatures of DNA repair deficiency. N.B. has served as a consultant to Apricity, BreakBio, Carisma Therapeutics, CureVac, Genetech, Novartis, Primevax, Tempest Therapeutics, Dragonfly Therapeutics, BioNTech, Genotwin and Rome Therapeutics. She has received research support from Harbour Biomed Sciences and Regeneron. J.Z. is an employee of GeneDx. S.G. received research funding from Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Genentech, Regeneron and Takeda. J.S. has served as a consultant or advisor for Natera, Pacific Edge, Merck, Urogen and Janssen. S.K.P. has received travel support form CRISPR Therapeutics and Ipsen. All remaining authors declare no competing interests."

"This trial was funded by Bristol Myers Squibb, and translational analyses were supported by the V Foundation for Cancer Research T2019-011 (M.D.G. and J.Z.). Scientific and financial support for the CIMAC-CIDC Network is provided through NCI Cooperative Agreements U24CA224319 (to the Icahn School of Medicine at Mount Sinai CIMAC), U24CA224331 (to the Dana-Farber Cancer Institute CIMAC), U24CA224285 (to the MD Anderson Cancer Center CIMAC) and U24CA224316 (to the CIDC at the Dana-Farber Cancer Institute). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Study GU16-257 was additionally supported through the Foundation for the National Institutes of Health (FNIH), in partnership with Friends of Cancer Research. Scientific and financial support for the Partnership for Accelerating Cancer Therapies public–private partnership are made possible through funding support provided to the FNIH by AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Genentech, Gilead, GlaxoSmithKline, Janssen, Novartis Institutes for Biomedical Research, Pfizer and Sanofi. Additional support for investigators included P30 CA196521 (M.D.G. and S.G.); R01 CA249175 (M.D.G.); T32 CA078207 (S.I.); NIH/LRP (S.I.); and U01 DK124165 (S.G.). This work used the services of the Tisch Cancer Institute Biorepository and Pathology Core. We thank Magdalena Thurin, Minkyung Song, Helen Chen and Goutham Reddy from NCI, Stacey Adam, Marquet Minor and Tetyana Murza from the FNIH, and Rebecca Enos from Emmes for their support. Author contributions: Conception and design: M.D.G. Financial support: M.D.G. Administrative support: M.D.G. and S.I. Provision of study materials: M.D.G., S.D., K.G.C., T.B.D., J.P.C., B.O., A.D., R.M., C.K., R.B., H.X., K.N., Y.K., E.E., R.M., S.G., J.S. and S.K.P. Collection and assembly of data: M.D.G., S.D., S.I., E.G., K.G.C., S.L., B.E., T.B.D., J.P.C., B.O., A.D., R.M., C.K., T.J., M.G., R.B., H.X., K.N., Y.K., E.E., Y.N., G.I., R.C., G.K.H., R.M., M.Y., Q.Z., S.K., R.S., J.Z., S.G., J.S. and S.K.P. Data analysis and interpretation: M.D.G., S.D., S.I., E.G., K.G.C., S.L., B.E., T.B.D., J.P.C., B.O., A.D., R.M., C.K., T.J., G.K., A.H., Y.N., G.I., R.C., L.W., K.W.M., R.M.S., N.B., Q.Z., S.K., R.S., J.Z., S.G., J.S. and S.K.P. Manuscript writing: M.D.G., E.G., S.L., T.J., Y.K., M.Y., Q.Z., S.K., R.S. and J.Z. Final approval of manuscript: M.D.G., S.D., S.I., E.G., K.G.C., S.L., B.E., T.B.D., J.P.C., B.O., A.D., R.M., C.K., T.J., M.G., R.B., H.X., K.N., G.K., A.H., Y.K., E.E., Y.N., G.I., R.C., G.K.H., L.W., K.W.M., R.M.S., R.M., N.B., M.Y., Q.Z., S.K., R.S., J.Z., S.G., J.S. and S.K.P. Accountable for all aspects of the work: M.D.G."