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The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC

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研究单位: [1]Adlai Nortye Biopharma Co., Ltd. [2]City of Hope,Duarte,California,United States,91010 [3]Yale University, Yale Cancer Center,New Haven,Connecticut,United States,06511 [4]Moffitt Cancer Center,Tampa,Florida,United States,33612 [5]Emory University,Atlanta,Georgia,United States,30322 [6]Northwestern University,Chicago,Illinois,United States,60611 [7]University of Kentucky,Lexington,Kentucky,United States,40536 [8]Norton Cancer Institute,Louisville,Kentucky,United States,40202 [9]University of Michigan,Ann Arbor,Michigan,United States,48109 [10]Karmanos Cancer Institute,Detroit,Michigan,United States,48201 [11]Henry Ford Health System,Detroit,Michigan,United States,48202 [12]Washington University School of Medicine,Saint Louis,Missouri,United States,63130 [13]Montefiore Medical Center,Bronx,New York,United States,10461 [14]NYU Langone,New York,New York,United States,10016 [15]Stony Brook University Medical Center,Stony Brook,New York,United States,11794 [16]Duke University Medical Center,Durham,North Carolina,United States,27710 [17]University of Cincinnati Cancer Center,Cincinnati,Ohio,United States,45219 [18]Fox Chase Cancer Center,Philadelphia,Pennsylvania,United States,19111 [19]UPMC Hillman Cancer Center,Pittsburgh,Pennsylvania,United States,15232 [20]Hollings Cancer Center,Charleston,South Carolina,United States,29425 [21]West Cancer Center,Germantown,Tennessee,United States,38138 [22]Hope Cancer Center, UT Health East Texas,Tyler,Texas,United States,75701 [23]Fundacion Cenit para la Investigacion en Neurociencias,Buenos Aires,Argentina,1125 [24]Centro de Investigacion Pergamino SA - Clinica Pergamino S.A.,Buenos Aires,Argentina,B2700CPM [25]Instituto de Investigaciones Metabólicas (IDIM) // Instituto de Investigaciones Metabólicas S.A.,Ciudad Autonoma de Buenos Aire,Argentina,C1012AAR [26]IONC SRL- Instituto Oncológico de Córdoba,Córdoba,Argentina,X5002HWE [27]Fundacion CORI para la Investigacion y Prevencion del Cáncer,La Rioja,Argentina,F5300COE [28]Centro para la Atencion Integral del Paciente Oncologico - CAIPO,Tucuman,Argentina,T4000GTB [29]Princess Alexandra Hospital,Brisbane,Australia,4102 [30]Universitair Ziekenhuis Gent UZ Gent,Ghent,Belgium,9000 [31]Universitair Ziekenhuis Brussel,Jette,Belgium,1090 [32]Clinique CHC MontLégia,Liege,Belgium,4000 [33]Clinique Saint-Pierre dOttignies CSPO,Ottignies,Belgium,1340 [34]CHUM,Montreal,Canada,H2X 0C2 [35]CancerCare Manitoba,Winnipeg,Canada,R3E 0V9 [36]Beijing Tongren Hospital,Beijing,China,100176 [37]The First Affiliated Hospital of Bengbu Medical College,Bengbu,China,233004 [38]Hunan Cancer Hospital,Changsha,China,410000 [39]Xiangya Hospital Central South University,Changsha,China,410000 [40]Sichuan Cancer Hospital,Chengdu,China,610042 [41]Affiliated Cancer Hospital of Chongqing University,Chongqing,China,400000 [42]The First Affiliated Hospital of CQMU,Chongqing,China,400042

关键词: Buparlisib PD1 PDL1

研究目的:
The BURAN study is a randomized, open-label phase III study to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with refractory, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC) that have progressed after prior anti PD 1/anti PD L1 monotherapy; prior anti PD 1/anti PD L1 therapy in combination with platinum-based therapy; or after sequential treatment of anti PD 1/anti PD L1 therapy, either prior to or post, platinum-based therapy.

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