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MD",{"facility":681,"status":47,"city":682,"state":43,"zip":683,"country":612,"countryCode":613,"cosmosGeoPoint":684,"geoPoint":688,"contacts":689},"Narodowy Instytut Onkologii im. Marii, Skłodowskiej-Curie","Warsaw","02-781",{"type":54,"coordinates":685},[686,687],21.01178,52.22977,{"lat":687,"lon":686},[690,694],{"name":691,"role":62,"phone":692,"phoneExt":43,"email":693},"Anna Pich","+ 48 22 546 2223","anna.pich@pib-nio.pl",{"name":695,"role":69,"phone":43,"phoneExt":43,"email":43},"Jan Walewski, MD",{"facility":697,"status":47,"city":698,"state":43,"zip":699,"country":700,"countryCode":701,"cosmosGeoPoint":702,"geoPoint":706,"contacts":707},"Bucharest Oncology Institute \"Prof.Dr.Al. Trestioreanu\"","Bucharest","022328","Romania","RO",{"type":54,"coordinates":703},[704,705],26.10626,44.43225,{"lat":705,"lon":704},[708,712],{"name":709,"role":62,"phone":710,"phoneExt":43,"email":711},"Monica Rosoiu, MD","+4078 3163 970","mirela.rosoiu@arensia-em.com",{"name":713,"role":69,"phone":43,"phoneExt":43,"email":43},"Laura-Aifer Calustian, MD",{"facility":715,"status":47,"city":716,"state":43,"zip":717,"country":700,"countryCode":701,"cosmosGeoPoint":718,"geoPoint":722,"contacts":723},"The Oncology Institute \"Prof. Dr. Ion Chiricuţă\" I.O.C.H.","Cluj-Napoca","400015",{"type":54,"coordinates":719},[720,721],23.6,46.76667,{"lat":721,"lon":720},[724,728,732],{"name":725,"role":62,"phone":726,"phoneExt":43,"email":727},"Nataliia Moskalenko","+4073 5888 501","nataliia.moskalenko@arensia-em.com",{"name":729,"role":62,"phone":730,"phoneExt":43,"email":731},"Hanna Varytska","+4076 0818 421","hanna.varytska@arensia-em.com",{"name":733,"role":69,"phone":43,"phoneExt":43,"email":43},"Delia Dima, MD",{"facility":735,"status":47,"city":736,"state":43,"zip":737,"country":738,"countryCode":739,"cosmosGeoPoint":740,"geoPoint":744,"contacts":745},"University Clinical Center of Serbia","Belgrade","11000","Serbia","RS",{"type":54,"coordinates":741},[742,743],20.46513,44.80401,{"lat":743,"lon":742},[746,750,754],{"name":747,"role":62,"phone":748,"phoneExt":43,"email":749},"Darko Antic, MD","+381 63 634 747","darko.antic1510976@gmail.com",{"name":751,"role":62,"phone":752,"phoneExt":43,"email":753},"Nikica Sabljic","+381 61 192 46 68","nsabljic19@gmail.com",{"name":755,"role":69,"phone":43,"phoneExt":43,"email":43},"Biljana Mihaljevic, MD",{"facility":757,"status":47,"city":758,"state":43,"zip":759,"country":738,"countryCode":739,"cosmosGeoPoint":760,"geoPoint":764,"contacts":765},"Oncology Institute of Vojvodina","Kamenitz","21204",{"type":54,"coordinates":761},[762,763],19.84263,45.22334,{"lat":763,"lon":762},[766,770],{"name":767,"role":62,"phone":768,"phoneExt":43,"email":769},"Dijana Zekic","+381 64 08 00 868","klinicka.istrazivanja@onk.ns.ac.rs",{"name":771,"role":69,"phone":43,"phoneExt":43,"email":43},"Lazar Popovic, MD",{"facility":773,"status":47,"city":774,"state":43,"zip":775,"country":738,"countryCode":739,"cosmosGeoPoint":776,"geoPoint":780,"contacts":781},"University Clinical Center Kragujevac","Kragujevac","34000",{"type":54,"coordinates":777},[778,779],20.91667,44.01667,{"lat":779,"lon":778},[782,786],{"name":783,"role":62,"phone":784,"phoneExt":43,"email":785},"Ana Dragovic","+381 65 325 97 65","anadragovicana@gmail.com",{"name":787,"role":69,"phone":43,"phoneExt":43,"email":43},"Predrag Djurdjevic, MD",{"facility":789,"status":47,"city":790,"state":43,"zip":791,"country":738,"countryCode":739,"cosmosGeoPoint":792,"geoPoint":796,"contacts":797},"Clinical Hospital Center Zemun","Zemun","11080",{"type":54,"coordinates":793},[794,795],20.40116,44.8458,{"lat":795,"lon":794},[798,802],{"name":799,"role":62,"phone":800,"phoneExt":43,"email":801},"Tamara Bibic","+381 60 511 10 45","tmedic83@gmail.com",{"name":803,"role":69,"phone":43,"phoneExt":43,"email":43},"Zorica Cvetkovic, MD",{"facility":805,"status":47,"city":806,"state":43,"zip":807,"country":808,"countryCode":809,"cosmosGeoPoint":810,"geoPoint":814,"contacts":815},"Hospital Santa Creu i Sant Pau","Barcelona","08041","Spain","ES",{"type":54,"coordinates":811},[812,813],2.15899,41.38879,{"lat":813,"lon":812},[816,821],{"name":817,"role":62,"phone":818,"phoneExt":819,"email":820},"Nuria Pérez","+34 93 291 90 00","8538","nperezg@santpau.cat",{"name":822,"role":69,"phone":43,"phoneExt":43,"email":43},"Javier Briones, MD",{"facility":824,"status":47,"city":825,"state":43,"zip":826,"country":808,"countryCode":809,"cosmosGeoPoint":827,"geoPoint":831,"contacts":832},"Hospital Universitario de Burgos","Burgos","09006",{"type":54,"coordinates":828},[829,830],-3.70184,42.34106,{"lat":830,"lon":829},[833,838],{"name":834,"role":62,"phone":835,"phoneExt":836,"email":837},"Raquel Alcaraz","+34 947281800","36078","ralcaraz@hubu.es",{"name":839,"role":69,"phone":43,"phoneExt":43,"email":43},"Jorge Labrado Gómez, MD",{"facility":841,"status":47,"city":842,"state":43,"zip":843,"country":808,"countryCode":809,"cosmosGeoPoint":844,"geoPoint":848,"contacts":849},"Hospital Universitario Virgen del Rocío","Seville","41013",{"type":54,"coordinates":845},[846,847],-5.97317,37.38283,{"lat":847,"lon":846},[850,854],{"name":851,"role":62,"phone":852,"phoneExt":43,"email":853},"Rocío Jiménez","+34 95 501 32 77","rociojimenezalvarez@gmail.com",{"name":855,"role":69,"phone":43,"phoneExt":43,"email":43},"Fatima de la Cruz Vicente, MD",{"type":857,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[859],{"name":860,"class":6},"Merck Sharp & Dohme LLC","100433168","phase-2-dpx-survivac-and-pembrolizumab-with-and-without-intermittent-low-dose-cyclophosphamide-in-subjects-with-relapsedrefractory-diffuse-large-b-cell-lymphoma-100433168",false,"NCT04920617","DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","A Phase 2b, Open-label, Multicenter, Randomized Parallel-Group, Two-Stage, Study of an Immunotherapeutic Treatment DPX-Survivac and Pembrolizumab, With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma (VITALIZE)","VITALIZE","Key Inclusion Criteria:\n\n* Adults ≥ 18 years of age who are willing and able to provide written informed consent\n* Have an ECOG performance status of ≤ 1. Subjects with an ECOG performance status of 2 may be enrolled with Medical Monitor approval.\n* Pathologically confirmed diagnosis of DLBCL, as defined by the 2016 World Health Organization classification including DLBCL NOS high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, Epstein-barr virus (EBV) positive DLBCL, and T cell rich B cell lymphoma (TCRBCL). Subjects with DLBCL transformed from indolent lymphoma (except for Richter's transformation) are eligible.\n* Subjects must have progressive disease following at least two (2) lines of prior systemic therapy for DLBCL; prior treatment must have included an anthracycline and rituximab (or another CD20-targeted agent).\n* Subjects must have failed or be ineligible for ASCT or CAR-T\n* Have at least one bi-dimensionally measurable lesion per Lugano (2014)\n* Willing to provide pre-treatment and on-treatment tumor biopsy tissue.\n* Meet protocol-specified laboratory requirements\n* Life expectancy \\> 3 months.\n\nKey Exclusion Criteria:\n\n* Primary CNS lymphoma or active secondary CNS involvement and\u002For lymphomatous meningitis\n* Chemotherapy, immunotherapy, major surgery, or investigational agent treatment within 28 days of D0 or 5 half-lives, whichever is shorter\n* Radiotherapy within 14 days of day 0\n* Autologous stem cell transplant (ASCT) within ˂100 days prior to D0\n* Chimeric antigen receptor T cell (CAR-T) therapy within ˂28 days prior to D0\n* Diagnosis of immunodeficiency disorder or history of active autoimmune disease that has required systemic treatment in the past 2 years\n* Uncontrolled significant active infections (controlled Hepatitis B, Hepatitis C, or HIV may be eligible)\n* Prior history of malignancy other than eligible lymphoma sub-types, unless the subject has been free of the disease for ≥ 2 years prior to the start of study treatment","ALL","18 Years",{"count":872,"type":873},102,"ESTIMATED","INTERVENTIONAL",[876],"PHASE2","This is a Phase 2b, randomized, open label study to assess the safety and efficacy of DPX-Survivac and pembrolizumab, with and without low-dose cyclophosphamide (CPA) in subjects with relapsed or refractory DLBCL.",[879,880],"Relapsed Diffuse Large B-cell Lymphoma","Refractory Diffuse Large B-cell Lymphoma",[882,883,884,885,886,887],"Immunotherapy","T cell activation","DLBCL","Anti-PD-1","CAR-T ineligible","ASCT ineligible","2023-04-05",{"date":890,"type":891},"2023-04-07","ACTUAL",{"date":893,"type":891},"2021-06-18",{"date":895,"type":873},"2025-04",{"name":5,"class":6},50]