{"id":"https://openalex.org/W4400522274","doi":"https://doi.org/10.1200/jco.2024.42.16_suppl.tps2100","title":"Randomized phase IIb trial of a CMV vaccine immunotherapeutic candidate (VBI-1901) in recurrent glioblastomas.","display_name":"Randomized phase IIb trial of a CMV vaccine immunotherapeutic candidate (VBI-1901) in recurrent glioblastomas.","publication_year":2024,"publication_date":"2024-06-01","ids":{"openalex":"https://openalex.org/W4400522274","doi":"https://doi.org/10.1200/jco.2024.42.16_suppl.tps2100"},"language":"en","primary_location":{"id":"doi:10.1200/jco.2024.42.16_suppl.tps2100","doi":"https://doi.org/10.1200/jco.2024.42.16_suppl.tps2100","is_oa":false,"landing_page_url":"https://doi.org/10.1200/jco.2024.42.16_suppl.tps2100","pdf_url":null,"source":{"id":"https://openalex.org/S15137598","display_name":"Journal of Clinical Oncology","issn_l":"0732-183X","issn":["0732-183X","1527-7755"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Clinical Oncology","raw_type":"journal-article"},"volume":null,"type":"conference-abstract","indexed_in":["crossref"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5087112179","display_name":"Ryan Thomas Merrell","orcid":"https://orcid.org/0000-0002-8076-0768","observed_orcids":["https://orcid.org/0000-0002-8076-0768"]},"institutions":[{"id":"https://openalex.org/I200719446","display_name":"Vanderbilt University","ror":"https://ror.org/02vm5rt34","country_code":"US","type":"education","lineage":["https://openalex.org/I200719446"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Ryan Thomas Merrell","raw_affiliation_strings":["Vanderbilt University, Nashville, TN"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Vanderbilt University, Nashville, TN","institution_ids":["https://openalex.org/I200719446"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5021656597","display_name":"Patrick Yung Wen","orcid":"https://orcid.org/0000-0002-0774-7700","observed_orcids":["https://orcid.org/0000-0002-0774-7700","https://orcid.org/0000-0003-3224-3042","https://orcid.org/0000-0002-2452-0540"]},"institutions":[{"id":"https://openalex.org/I136199984","display_name":"Harvard University","ror":"https://ror.org/03vek6s52","country_code":"US","type":"education","lineage":["https://openalex.org/I136199984"]},{"id":"https://openalex.org/I4210117453","display_name":"Dana-Farber Cancer Institute","ror":"https://ror.org/02jzgtq86","country_code":"US","type":"facility","lineage":["https://openalex.org/I4210117453"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Patrick Y. Wen","raw_affiliation_strings":["Division of Neuro-Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Division of Neuro-Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA","institution_ids":["https://openalex.org/I136199984","https://openalex.org/I4210117453"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5082403426","display_name":"Deborah Anne Forst","orcid":"https://orcid.org/0000-0002-8428-0841","observed_orcids":["https://orcid.org/0000-0002-8428-0841"]},"institutions":[{"id":"https://openalex.org/I4210087915","display_name":"Massachusetts General Hospital","ror":"https://ror.org/002pd6e78","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210087915","https://openalex.org/I48633490"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Deborah Anne Forst","raw_affiliation_strings":["Massachusetts General Hospital, Boston, MA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Massachusetts General Hospital, Boston, MA","institution_ids":["https://openalex.org/I4210087915"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5076256448","display_name":"Jessica D. Schulte","orcid":"https://orcid.org/0000-0002-7135-9200","observed_orcids":["https://orcid.org/0000-0002-7135-9200"]},"institutions":[{"id":"https://openalex.org/I36258959","display_name":"University of California San Diego","ror":"https://ror.org/0168r3w48","country_code":"US","type":"education","lineage":["https://openalex.org/I36258959"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Jessica Schulte","raw_affiliation_strings":["University of California, San Diego, La Jolla, CA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of California, San Diego, La Jolla, CA","institution_ids":["https://openalex.org/I36258959"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5038295657","display_name":"Yazm\u00edn Odia","orcid":"https://orcid.org/0000-0003-3602-3899","observed_orcids":["https://orcid.org/0000-0003-3602-3899"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Yazmin Odia","raw_affiliation_strings":["Miami Cancer Institute, Miami, FL"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Miami Cancer Institute, Miami, FL","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5041536073","display_name":"Daniela Annenelie Bota","orcid":"https://orcid.org/0000-0002-9680-9060","observed_orcids":["https://orcid.org/0000-0002-9680-9060"]},"institutions":[{"id":"https://openalex.org/I4210096636","display_name":"University of California, Irvine Medical Center","ror":"https://ror.org/00cm8nm15","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210096636","https://openalex.org/I4210137750"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Daniela Annenelie Bota","raw_affiliation_strings":["University of California, Irvine Medical Center, Orange, CA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of California, Irvine Medical Center, Orange, CA","institution_ids":["https://openalex.org/I4210096636"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5017186738","display_name":"Francisco D\u00edaz\u2010Mitoma","orcid":"https://orcid.org/0000-0003-0292-4859","observed_orcids":["https://orcid.org/0000-0003-0292-4859"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Francisco Diaz-Mitoma","raw_affiliation_strings":["VBI Vaccines, Cambridge, MA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"VBI Vaccines, Cambridge, MA","institution_ids":[]}]},{"author_position":"middle","author":{"id":null,"display_name":"David E Anderson","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"David E Anderson","raw_affiliation_strings":["VBI Vaccines, Cambridge, MA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"VBI Vaccines, Cambridge, MA","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5057541817","display_name":"Andrew B. Lassman","orcid":"https://orcid.org/0000-0001-7386-9928","observed_orcids":["https://orcid.org/0000-0001-7386-9928"]},"institutions":[{"id":"https://openalex.org/I78577930","display_name":"Columbia University","ror":"https://ror.org/00hj8s172","country_code":"US","type":"education","lineage":["https://openalex.org/I78577930"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Andrew B. Lassman","raw_affiliation_strings":["Neuro-Oncology, Columbia University, New York, NY"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Neuro-Oncology, Columbia University, New York, NY","institution_ids":["https://openalex.org/I78577930"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5087754052","display_name":"FABIO MASSAITI IWAMOTO","orcid":"https://orcid.org/0000-0003-1397-9927","observed_orcids":["https://orcid.org/0000-0003-1397-9927"]},"institutions":[{"id":"https://openalex.org/I2799503643","display_name":"Columbia University Irving Medical Center","ror":"https://ror.org/01esghr10","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I2799503643"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Fabio Massaiti Iwamoto","raw_affiliation_strings":["Columbia University Irving Medical Center, New York, NY"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Columbia University Irving Medical Center, New York, NY","institution_ids":["https://openalex.org/I2799503643"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":8,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":null,"has_fulltext":false,"cited_by_count":4,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"biblio":{"volume":"42","issue":"16_suppl","first_page":"TPS2100","last_page":"TPS2100"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10129","display_name":"Glioma Diagnosis and Treatment","score":0.9218999743461609,"subfield":{"id":"https://openalex.org/subfields/2716","display_name":"Genetics (clinical)"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10129","display_name":"Glioma Diagnosis and Treatment","score":0.9218999743461609,"subfield":{"id":"https://openalex.org/subfields/2716","display_name":"Genetics (clinical)"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10580","display_name":"Immunotherapy and Immune Responses","score":0.050599999725818634,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T10981","display_name":"Cytomegalovirus and herpesvirus research","score":0.015599999576807022,"subfield":{"id":"https://openalex.org/subfields/2713","display_name":"Epidemiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/recurrent-glioblastoma","display_name":"recurrent glioblastoma","score":0.9120000004768372},{"id":"https://openalex.org/keywords/cytomegalovirus-vaccine","display_name":"cytomegalovirus vaccine","score":0.8830000162124634},{"id":"https://openalex.org/keywords/pp65-antigen","display_name":"pp65 antigen","score":0.7300000190734863},{"id":"https://openalex.org/keywords/virus-like-particle-vaccine","display_name":"virus-like particle vaccine","score":0.890999972820282},{"id":"https://openalex.org/keywords/gm-csf-adjuvant","display_name":"GM-CSF adjuvant","score":0.8989999890327454},{"id":"https://openalex.org/keywords/cancer-immunotherapy","display_name":"cancer immunotherapy","score":0.6179999709129333},{"id":"https://openalex.org/keywords/cd4-t-cells","display_name":"CD4+ T cells","score":0.6190000176429749},{"id":"https://openalex.org/keywords/cd8-t-cells","display_name":"CD8+ T cells","score":0.8569999933242798},{"id":"https://openalex.org/keywords/humoral-immune-response","display_name":"humoral immune response","score":0.6439999938011169},{"id":"https://openalex.org/keywords/disease-control-rate","display_name":"disease control rate","score":0.6330000162124634},{"id":"https://openalex.org/keywords/lomustine","display_name":"lomustine","score":0.7649999856948853},{"id":"https://openalex.org/keywords/carmustine","display_name":"BCNU","score":0.9909999966621399}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.8717877864837646},{"id":"https://openalex.org/C168563851","wikidata":"https://www.wikidata.org/wiki/Q1436668","display_name":"Randomized controlled trial","level":2,"score":0.4871973395347595},{"id":"https://openalex.org/C2777701055","wikidata":"https://www.wikidata.org/wiki/Q1427096","display_name":"Immunotherapy","level":3,"score":0.44380685687065125},{"id":"https://openalex.org/C143998085","wikidata":"https://www.wikidata.org/wiki/Q162555","display_name":"Oncology","level":1,"score":0.4120520353317261},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.37522992491722107},{"id":"https://openalex.org/C121608353","wikidata":"https://www.wikidata.org/wiki/Q12078","display_name":"Cancer","level":2,"score":0.20904549956321716}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1200/jco.2024.42.16_suppl.tps2100","doi":"https://doi.org/10.1200/jco.2024.42.16_suppl.tps2100","is_oa":false,"landing_page_url":"https://doi.org/10.1200/jco.2024.42.16_suppl.tps2100","pdf_url":null,"source":{"id":"https://openalex.org/S15137598","display_name":"Journal of Clinical Oncology","issn_l":"0732-183X","issn":["0732-183X","1527-7755"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Clinical Oncology","raw_type":"journal-article"}],"best_oa_location":null,"sustainable_development_goals":[{"display_name":"Good health and well-being","score":1.0,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W4281718415","https://openalex.org/W4404237153","https://openalex.org/W3167478751","https://openalex.org/W2947884939","https://openalex.org/W2987136825","https://openalex.org/W3083077017","https://openalex.org/W2986788024","https://openalex.org/W3088384805","https://openalex.org/W4309016323","https://openalex.org/W4400522280"],"abstract_inverted_index":{"TPS2100":[0],"Background:":[1],"Cytomegalovirus":[2],"(CMV)":[3],"antigens":[4],"have":[5,258,284,471],"been":[6,301,472],"reported":[7],"in":[8,33,47,144,153,399,427,443,457],"over":[9],"90%":[10],"of":[11,40,93,113,177,195,222,245,325,397,413,425,454,462,468],"GBMs.":[12],"CD4+":[13,154],"and":[14,25,101,148,313,405,450,474],"CD8+":[15],"T":[16,157],"cells":[17,158],"are":[18,30,280,330,339,357,416],"most":[19,130],"frequently":[20],"directed":[21],"against":[22,159],"the":[23,94,114,122,129,174,179,202,311,350,360,400,428,433,444,458],"gB":[24,146],"pp65":[26,161],"antigens,":[27],"respectively,":[28],"which":[29,190,273],"immunogenic":[31],"targets":[32],"a":[34,48,52,61,193,207,233,268,285,317,322,335,373,380,388,406,410,420,441,451],"CMV-based":[35],"GBM":[36,43],"immunotherapeutic.":[37],"A":[38],"total":[39,411],"28":[41],"first-recurrent":[42],"subjects":[44,172,214,315,398],"were":[45,104,165],"enrolled":[46],"trial,":[49],"designed":[50],"as":[51,332,372],"single":[53],"arm,":[54],"3-dose":[55],"escalation":[56],"phase":[57,63,352],"(n=18)":[58],"followed":[59],"by":[60],"dose-expansion":[62,123],"(n=10),":[64],"to":[65,138,236,240,342,344,418,432,440],"receive":[66],"VBI-1901":[67,242,347,429,449],"(a":[68],"gB/pp65":[69],"enveloped":[70],"virus-like":[71],"particle":[72],"vaccine":[73,97],"immunotherapeutic":[74],"adjuvanted":[75],"with":[76,111,135,142,151,167,219,249,267,316,334,346,383,393,448],"GM-CSF)":[77],"given":[78],"intradermally":[79],"every":[80],"4":[81],"weeks":[82],"until":[83],"clinical":[84],"disease":[85,180],"progression":[86],"(NCT03382977).":[87],"In":[88],"Phase":[89],"I":[90],"(Part":[91],"A)":[92],"study,":[95,312],"3":[96],"doses":[98],"(0.4\u00b5g,":[99],"2\u00b5g,":[100],"10\u00b5g":[102,117],"pp65)":[103],"evaluated.":[105],"No":[106],"DLTs":[107],"or":[108,217,243,251,290],"safety":[109,361],"concerns":[110],"any":[112],"doses.":[115],"The":[116,253,354],"dose":[118,176],"was":[119,128,183,204],"chosen":[120],"for":[121,303,423],"phase.":[124],"Injection":[125],"site":[126],"erythema":[127],"common":[131],"adverse":[132],"event.":[133],"Vaccination":[134],"VB-1901":[136],"led":[137],"both":[139],"humoral":[140],"response":[141,150,377],"increase":[143,152],"CMV":[145,160],"antibodies,":[147],"cellular":[149],"effector":[155],"memory":[156],"antigen;":[162],"immunological":[163],"responses":[164],"associated":[166],"MRI/clinical":[168],"response.":[169],"Among":[170],"16":[171],"receiving":[173],"highest":[175],"VBI-1901,":[178],"control":[181],"rate":[182,378],"44%,":[184],"including":[185],"2":[186,296],"durable":[187],"partial":[188],"responses,":[189],"translated":[191],"into":[192,206,310],"mOS":[194,445,453],"12.9":[196],"months.":[197],"Based":[198],"on":[199,349],"these":[200],"results,":[201],"study":[203],"amended":[205],"randomized":[208,231,473],"study.":[209,353],"Methods:":[210],"Approximately":[211],"60":[212,469],"adult":[213],"(18":[215],"years":[216],"older)":[218],"first":[220,270],"recurrence":[221,271],"WHO":[223],"2016":[224],"grade":[225],"IV":[226],"Glioblastoma,":[227],"IDH-wildtype":[228],"will":[229,369],"be":[230,276,294,370],"at":[232,304,328],"1:1":[234],"ratio":[235,319,422,438],"two":[237,401],"open-label":[238],"cohorts":[239],"receive:":[241],"standard":[244],"care":[246],"(SOC)":[247],"treatment":[248],"lomustine":[250],"carmustine.":[252],"contrast-enhancing":[254],"lesion":[255],"may":[256,274],"not":[257,275],"an":[259,394],"area":[260],"measuring":[261],"greater":[262],"than":[263],"600":[264],"mm2":[265],"(subjects":[266],"resected":[269],"tumor,":[272],"measurable":[277],"after":[278],"surgery,":[279],"eligible).":[281],"Subjects":[282],"must":[283,293],"KPS":[286],"\u226570,":[287],"corticosteroid":[288],"(dexamethasone":[289],"equivalent)":[291],"dosage":[292],"\u2264":[295],"mg":[297],"daily":[298],"that":[299],"has":[300],"stable":[302],"least":[305],"5":[306],"days":[307],"before":[308],"randomization":[309],"only":[314],"CD4/CD8":[318],"\u22651":[320],"OR":[321],"CD4":[323],"count":[324],"\u2265":[326],"400/uL":[327],"screening":[329],"eligible,":[331],"people":[333],"preserved":[336],"immune":[337],"system":[338],"more":[340],"likely":[341],"respond":[343],"immunization":[345],"based":[348],"initial":[351],"primary":[355],"endpoints":[356],"hierarchical.":[358],"If":[359],"endpoint":[362,382],"is":[363,379],"achieved,":[364],"then":[365],"efficacy":[366],"(overall":[367],"survival)":[368],"considered":[371],"co-primary":[374],"endpoint.":[375],"Tumor":[376],"secondary":[381],"planned":[384],"interim":[385],"analyses.":[386],"For":[387],"one-sided":[389],"log":[390],"rank":[391],"test":[392],"equal":[395],"allocation":[396],"groups,":[402],"80%":[403],"power":[404],"0.20":[407],"significance":[408],"level,":[409],"number":[412],"47":[414],"events":[415],"needed":[417],"detect":[419],"hazard":[421,437],"mortality":[424],"0.6145":[426],"cohort":[430],"relative":[431],"SOC":[434,459],"cohort.":[435],"This":[436],"corresponds":[439],"difference":[442],"observed":[446],"previously":[447],"historical":[452],"8":[455,477],"months":[456],"group.":[460],"As":[461],"January":[463],"31st":[464],"2024":[465],",":[466],"12":[467],"patients":[470],"dosed":[475],"across":[476],"US":[478],"sites.":[479],"Clinical":[480],"trial":[481],"information:":[482],"NCT03382977":[483],".":[484]},"counts_by_year":[{"year":2026,"cited_by_count":2},{"year":2025,"cited_by_count":2}],"updated_date":"2026-11-04T10:54:05.112534","created_date":"2024-07-12T00:00:00"}
