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Marii, Skłodowskiej-Curie","Warsaw","02-781",{"type":53,"coordinates":678},[679,680],21.01178,52.22977,{"lat":680,"lon":679},[683,687],{"name":684,"role":61,"phone":685,"phoneExt":43,"email":686},"Anna Pich","+ 48 22 546 2223","anna.pich@pib-nio.pl",{"name":688,"role":68,"phone":43,"phoneExt":43,"email":43},"Jan Walewski, MD",{"facility":690,"status":47,"city":691,"state":43,"zip":692,"country":693,"cosmosGeoPoint":694,"geoPoint":698,"contacts":699},"Bucharest Oncology Institute \"Prof.Dr.Al. Trestioreanu\"","Bucharest","022328","Romania",{"type":53,"coordinates":695},[696,697],26.10626,44.43225,{"lat":697,"lon":696},[700,704],{"name":701,"role":61,"phone":702,"phoneExt":43,"email":703},"Monica Rosoiu, MD","+4078 3163 970","mirela.rosoiu@arensia-em.com",{"name":705,"role":68,"phone":43,"phoneExt":43,"email":43},"Laura-Aifer Calustian, MD",{"facility":707,"status":47,"city":708,"state":43,"zip":709,"country":693,"cosmosGeoPoint":710,"geoPoint":714,"contacts":715},"The Oncology Institute \"Prof. Dr. Ion Chiricuţă\" I.O.C.H.","Cluj-Napoca","400015",{"type":53,"coordinates":711},[712,713],23.6,46.76667,{"lat":713,"lon":712},[716,720,724],{"name":717,"role":61,"phone":718,"phoneExt":43,"email":719},"Nataliia Moskalenko","+4073 5888 501","nataliia.moskalenko@arensia-em.com",{"name":721,"role":61,"phone":722,"phoneExt":43,"email":723},"Hanna Varytska","+4076 0818 421","hanna.varytska@arensia-em.com",{"name":725,"role":68,"phone":43,"phoneExt":43,"email":43},"Delia Dima, MD",{"facility":727,"status":47,"city":728,"state":43,"zip":729,"country":730,"cosmosGeoPoint":731,"geoPoint":735,"contacts":736},"University Clinical Center of Serbia","Belgrade","11000","Serbia",{"type":53,"coordinates":732},[733,734],20.46513,44.80401,{"lat":734,"lon":733},[737,741,745],{"name":738,"role":61,"phone":739,"phoneExt":43,"email":740},"Darko Antic, MD","+381 63 634 747","darko.antic1510976@gmail.com",{"name":742,"role":61,"phone":743,"phoneExt":43,"email":744},"Nikica Sabljic","+381 61 192 46 68","nsabljic19@gmail.com",{"name":746,"role":68,"phone":43,"phoneExt":43,"email":43},"Biljana Mihaljevic, MD",{"facility":748,"status":47,"city":749,"state":43,"zip":750,"country":730,"cosmosGeoPoint":751,"geoPoint":755,"contacts":756},"Oncology Institute of Vojvodina","Kamenitz","21204",{"type":53,"coordinates":752},[753,754],19.84263,45.22334,{"lat":754,"lon":753},[757,761],{"name":758,"role":61,"phone":759,"phoneExt":43,"email":760},"Dijana Zekic","+381 64 08 00 868","klinicka.istrazivanja@onk.ns.ac.rs",{"name":762,"role":68,"phone":43,"phoneExt":43,"email":43},"Lazar Popovic, MD",{"facility":764,"status":47,"city":765,"state":43,"zip":766,"country":730,"cosmosGeoPoint":767,"geoPoint":771,"contacts":772},"University Clinical Center Kragujevac","Kragujevac","34000",{"type":53,"coordinates":768},[769,770],20.91667,44.01667,{"lat":770,"lon":769},[773,777],{"name":774,"role":61,"phone":775,"phoneExt":43,"email":776},"Ana Dragovic","+381 65 325 97 65","anadragovicana@gmail.com",{"name":778,"role":68,"phone":43,"phoneExt":43,"email":43},"Predrag Djurdjevic, MD",{"facility":780,"status":47,"city":781,"state":43,"zip":782,"country":730,"cosmosGeoPoint":783,"geoPoint":787,"contacts":788},"Clinical Hospital Center Zemun","Zemun","11080",{"type":53,"coordinates":784},[785,786],20.40116,44.8458,{"lat":786,"lon":785},[789,793],{"name":790,"role":61,"phone":791,"phoneExt":43,"email":792},"Tamara Bibic","+381 60 511 10 45","tmedic83@gmail.com",{"name":794,"role":68,"phone":43,"phoneExt":43,"email":43},"Zorica Cvetkovic, MD",{"facility":796,"status":47,"city":797,"state":43,"zip":798,"country":799,"cosmosGeoPoint":800,"geoPoint":804,"contacts":805},"Hospital Santa Creu i Sant Pau","Barcelona","08041","Spain",{"type":53,"coordinates":801},[802,803],2.15899,41.38879,{"lat":803,"lon":802},[806,811],{"name":807,"role":61,"phone":808,"phoneExt":809,"email":810},"Nuria Pérez","+34 93 291 90 00","8538","nperezg@santpau.cat",{"name":812,"role":68,"phone":43,"phoneExt":43,"email":43},"Javier Briones, MD",{"facility":814,"status":47,"city":815,"state":43,"zip":816,"country":799,"cosmosGeoPoint":817,"geoPoint":821,"contacts":822},"Hospital Universitario de Burgos","Burgos","09006",{"type":53,"coordinates":818},[819,820],-3.70184,42.34106,{"lat":820,"lon":819},[823,828],{"name":824,"role":61,"phone":825,"phoneExt":826,"email":827},"Raquel Alcaraz","+34 947281800","36078","ralcaraz@hubu.es",{"name":829,"role":68,"phone":43,"phoneExt":43,"email":43},"Jorge Labrado Gómez, MD",{"facility":831,"status":47,"city":832,"state":43,"zip":833,"country":799,"cosmosGeoPoint":834,"geoPoint":838,"contacts":839},"Hospital Universitario Virgen del Rocío","Seville","41013",{"type":53,"coordinates":835},[836,837],-5.97317,37.38283,{"lat":837,"lon":836},[840,844],{"name":841,"role":61,"phone":842,"phoneExt":43,"email":843},"Rocío Jiménez","+34 95 501 32 77","rociojimenezalvarez@gmail.com",{"name":845,"role":68,"phone":43,"phoneExt":43,"email":43},"Fatima de la Cruz Vicente, MD",{"type":847,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[849],{"name":850,"class":6},"Merck Sharp & Dohme LLC","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":861,"type":862},102,"ESTIMATED","INTERVENTIONAL",[865],"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.",[868,869],"Relapsed Diffuse Large B-cell Lymphoma","Refractory Diffuse Large B-cell Lymphoma",[871,872,873,874,875,876],"Immunotherapy","T cell activation","DLBCL","Anti-PD-1","CAR-T ineligible","ASCT ineligible","2023-04-05",{"date":879,"type":880},"2023-04-07","ACTUAL",{"date":882,"type":880},"2021-06-18",{"date":884,"type":862},"2025-04",{"name":5,"class":6},50]