{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T19:39:40Z","timestamp":1790019580544,"version":"4.0.1"},"reference-count":20,"publisher":"Elsevier BV","issue":"4","license":[{"start":{"date-parts":[[2017,4,1]],"date-time":"2017-04-01T00:00:00Z","timestamp":1491004800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2019,10,30]],"date-time":"2019-10-30T00:00:00Z","timestamp":1572393600000},"content-version":"vor","delay-in-days":942,"URL":"http:\/\/www.elsevier.com\/open-access\/userlicense\/1.0\/"}],"funder":[{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher","award":["K25CA181638, R01CA142859, R01CA178846"],"award-info":[{"award-number":["K25CA181638, R01CA142859, R01CA178846"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Biostatistics Shared Resource, University of Virginia Cancer Center, University of Virginia","award":["P30 CA044579"],"award-info":[{"award-number":["P30 CA044579"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Annals of Oncology"],"published-print":{"date-parts":[[2017,4]]},"DOI":"10.1093\/annonc\/mdw681","type":"journal-article","created":{"date-parts":[[2016,12,16]],"date-time":"2016-12-16T23:03:06Z","timestamp":1481929386000},"page":"696-701","source":"Crossref","is-referenced-by-count":20,"title":["Statistical controversies in clinical research: early-phase adaptive design for combination immunotherapies"],"prefix":"10.1016","volume":"28","author":[{"given":"N.A.","family":"Wages","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr","given":"C.L.","family":"Slingluff","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.R.","family":"Petroni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1093\/annonc\/mdw681_bb0010","doi-asserted-by":"crossref","first-page":"1808","DOI":"10.1093\/annonc\/mdv266","article-title":"Statistical controversies in clinical research: requiem for the 3 + 3 design for phase I trials","volume":"26","author":"Paoletti","year":"2015","journal-title":"Ann Oncol"},{"key":"10.1093\/annonc\/mdw681_bb0015","doi-asserted-by":"crossref","first-page":"2505","DOI":"10.1200\/JCO.2013.54.6051","article-title":"Adaptive dose-finding studies: a review of model-guided phase I clinical trials","volume":"32","author":"Iasonos","year":"2014","journal-title":"J Clin Oncol"},{"key":"10.1093\/annonc\/mdw681_bb0020","doi-asserted-by":"crossref","first-page":"4758","DOI":"10.1158\/1078-0432.CCR-13-2671","article-title":"Is the \u201c3 + 3\u201d dose-escalation phase I clinical trial design suitable for therapeutic cancer vaccine development? A recommendation for alternative design","volume":"20","author":"Rahma","year":"2014","journal-title":"Clin Cancer Res"},{"key":"10.1093\/annonc\/mdw681_bb0025","doi-asserted-by":"crossref","first-page":"2623","DOI":"10.1158\/1078-0432.CCR-15-2644","article-title":"Rendering the 3 + 3 design to rest: more efficient approaches to oncology dose-finding trials in the era of targeted therapy","volume":"22","author":"Nie","year":"2016","journal-title":"Clin Cancer Res"},{"key":"10.1093\/annonc\/mdw681_bb0030","unstructured":"FDA USDoHaHS, Administration FaD, Research CfBEa. Guidance for industry clinical considerations for therapeutic cancer vaccines 2011; [cited 2011 October 2011].http:\/\/www.fda.gov\/downloads\/BiologicsBloodVaccines\/GuidanceComplianceRegulatoryInformation\/Guidances\/Vaccines\/UCM278673.pdf (31 December 2016, date last accessed)."},{"key":"10.1093\/annonc\/mdw681_bb0035","doi-asserted-by":"crossref","first-page":"1990","DOI":"10.1002\/sim.6097","article-title":"Phase I\/II adaptive design for drug combination oncology trials","volume":"33","author":"Wages","year":"2014","journal-title":"Stat Med"},{"key":"10.1093\/annonc\/mdw681_bb0040","doi-asserted-by":"crossref","first-page":"172","DOI":"10.1016\/j.cct.2015.01.016","article-title":"A phase I\/II adaptive design to determine the optimal treatment arm from a set of combination immunotherapies in high-risk melanoma","volume":"41","author":"Wages","year":"2015","journal-title":"Contemp Clin Trials"},{"key":"10.1093\/annonc\/mdw681_bb0045","doi-asserted-by":"crossref","first-page":"2221","DOI":"10.1200\/JCO.2014.59.8466","article-title":"Scientific review of Phase I protocols with novel dose-escalation designs: how much information is needed?","volume":"33","author":"Iasonos","year":"2015","journal-title":"J Clin Oncol"},{"key":"10.1093\/annonc\/mdw681_bb0050","article-title":"Implementation of adaptive methods in early-phase clinical trials","author":"Petroni","year":"2016","journal-title":"Stat Med"},{"key":"10.1093\/annonc\/mdw681_bb0055","doi-asserted-by":"crossref","first-page":"4973","DOI":"10.1200\/JCO.2008.17.3161","article-title":"Helper T-cell responses and clinical activity of a melanoma vaccine with multiple peptides from MAGE and melanocytic differentiation antigens","volume":"26","author":"Slingluff","year":"2008","journal-title":"J Clin Oncol"},{"key":"10.1093\/annonc\/mdw681_bb0060","doi-asserted-by":"crossref","first-page":"2924","DOI":"10.1200\/JCO.2010.33.8053","article-title":"A randomized multicenter trial of the effects of melanoma-associated helper peptides and cyclophosphamide on the immunogenicity of a multipeptide melanoma vaccine","volume":"29","author":"Slingluff","year":"2011","journal-title":"J Clin Oncol"},{"key":"10.1093\/annonc\/mdw681_bb0065","doi-asserted-by":"crossref","first-page":"25","DOI":"10.1007\/s00262-015-1770-9","article-title":"A randomized pilot trial testing the safety and immunologic effects of MAGE-A3 protein plus AS15 immunostimulant administered into muscle or into dermal\/subcutaneous sites","volume":"65","author":"Slingluff","year":"2016","journal-title":"Cancer Immunol Immunother"},{"key":"10.1093\/annonc\/mdw681_bb0070","doi-asserted-by":"crossref","first-page":"6386","DOI":"10.1158\/1078-0432.CCR-07-0486","article-title":"Immunologic and clinical outcomes of a randomized phase II trial of two multipeptide vaccines for melanoma in the adjuvant setting","volume":"13","author":"Slingluff","year":"2007","journal-title":"Clin Cancer Res"},{"key":"10.1093\/annonc\/mdw681_bb0075","doi-asserted-by":"crossref","first-page":"33","DOI":"10.2307\/2531628","article-title":"Continual reassessment method: a practical design for phase I clinical trials in cancer","volume":"46","author":"O\u2019Quigley","year":"1990","journal-title":"Biometrics"},{"key":"10.1093\/annonc\/mdw681_bb0080","doi-asserted-by":"crossref","first-page":"3012","DOI":"10.1002\/sim.3682","article-title":"A comparison of model choices for the continual reassessment method in phase I clinical trials","volume":"28","author":"Paoletti","year":"2009","journal-title":"Statist Med"},{"key":"10.1093\/annonc\/mdw681_bb0085","doi-asserted-by":"crossref","first-page":"227","DOI":"10.1177\/1740774509105076","article-title":"Model calibration in the continual reassessment method","volume":"6","author":"Lee","year":"2009","journal-title":"Clin Trials"},{"key":"10.1093\/annonc\/mdw681_bb0090","doi-asserted-by":"crossref","first-page":"1829","DOI":"10.1002\/sim.1443","article-title":"Interval estimates of the probability of toxicity at the maximum tolerated dose for small samples","volume":"22","author":"Natarajan","year":"2003","journal-title":"Statist Med"},{"key":"10.1093\/annonc\/mdw681_bb0095","doi-asserted-by":"crossref","first-page":"785","DOI":"10.1080\/10543406.2012.676586","article-title":"Adaptive randomization to improve utility-based dose-finding with bivariate ordinal outcomes","volume":"22","author":"Thall","year":"2012","journal-title":"J Biopharm Stat"},{"key":"10.1093\/annonc\/mdw681_bb0100","series-title":"R: A Language and Environment for Statistical Computing","year":"2016"},{"key":"10.1093\/annonc\/mdw681_bb0105","doi-asserted-by":"crossref","first-page":"1036","DOI":"10.1093\/annonc\/mdv075","article-title":"Recent developments in the implementation of novel designs for early-phase combination studies","volume":"26","author":"Wages","year":"2015","journal-title":"Ann Oncol"}],"container-title":["Annals of Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0923753419320538?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0923753419320538?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/academic.oup.com\/annonc\/article-pdf\/28\/4\/696\/11121322\/mdw681.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,6,26]],"date-time":"2021-06-26T08:16:32Z","timestamp":1624695392000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0923753419320538"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,4]]},"references-count":20,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2017,4]]}},"alternative-id":["S0923753419320538"],"URL":"https:\/\/doi.org\/10.1093\/annonc\/mdw681","relation":{},"ISSN":["0923-7534"],"issn-type":[{"value":"0923-7534","type":"print"}],"subject":[],"published":{"date-parts":[[2017,4]]}}}