Author contributions
toxicity, A. Dobrin, N.Ceglia, MSK, T.M., T.P.K.
PATHOLOGY
V.P.B., J.D.W., T.M., Ö.T., I.M. and U.S. conceived the clinical trial concept. N.Cohen, E.O.R. and V.P.B. designed the clinical trial. V.P.B. and E.O.R. oversaw all aspects of clinical trial conduct as primary and co-primary investigators, respectively. A.S.E., P.M., W.P., R.S., A.M.V., E.W., A. Desai, E.O.R., K.C.S., A.C.W., M.I.D., T.P.K., W.R.J., J.D. and V.P.B. enrolled patients to the clinical trial. K.C.S., A.C.W., M.I.D., T.P.K., W.R.J., J.D. and V.P.B. performed the surgeries. A.S.E., P.M., W.P., R.S., A.M.V., E.W., A. Desai, E.O.R. and V.P.B. administered the experimental medicines and evaluated toxicity. C.O. and N.P. led the MSK clinical trial research study team. S.K. and R.K.D performed the radiography assessments. O.B. and L.T. performed all the pathology assessments. L.A.R. performed the immunological assays with assistance from A. Dobrin, R.Y., A.K.C., T.W., J.R., M.A., P.G., A.Z., Z.O. and G.P. M.S. assisted with TCR cloning. Immunological analysis by IFNγ ELISpot was performed by E.D. (BioNTech). L.A.R., Z.S., B.D.G. and V.P.B. developed CloneTrack. Z.S. performed all computational analyses using CloneTrack. M.Ł., Z.S., L.A.R., B.D.G. and V.P.B. conceived and developed the neoantigen quality model. Z.S., J.L., A.C. and M.Ł. performed the clonality reconstructions. Z.S. performed the neoantigen quality assessments. Exome sequencing, RNA sequencing, identification of neoantigens, neoantigen selection, individualized mRNA vaccine design and manufacturing were performed by the BioNTech team coordinated by F.M. Z.S. and N.Ceglia performed the single-cell analyses. M.G. provided statistical oversight. The MSK team collected, analysed and interpreted all data, with critical feedback from all authors. L.A.R., Z.S., E.P., E.D., F.M., I.R., M.Y., T.M., J.D.W., I.M., U.S., Ö.T., B.D.G. and V.P.B. participated in critical discussions and manuscript writing. The funders had no role in the conduct of the trial or end point analyses. The authors assume responsibility for the completeness and accuracy of the data and for the fidelity of the trial to the protocol and statistical analysis plan.