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Herzen Oncological Inst. ; Oncology","125248",{"facility":1183,"status":37,"city":1184,"state":1185,"zip":1186,"country":1177,"countryCode":1178,"cosmosGeoPoint":1187,"geoPoint":1191,"contacts":37},"SBEI HPE \"The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova\"of MoH of RF","Saint Petersburg","Sankt-Peterburg","197022",{"type":47,"coordinates":1188},[1189,1190],30.31413,59.93863,{"lat":1190,"lon":1189},{"facility":1193,"status":37,"city":1194,"state":37,"zip":1195,"country":1196,"countryCode":37,"cosmosGeoPoint":1197,"geoPoint":1201,"contacts":37},"National Cancer Center","Goyang-si","10408","South Korea",{"type":47,"coordinates":1198},[1199,1200],126.835,37.65639,{"lat":1200,"lon":1199},{"facility":1203,"status":37,"city":1204,"state":37,"zip":1205,"country":1196,"countryCode":37,"cosmosGeoPoint":1206,"geoPoint":1210,"contacts":37},"Seoul National University Hospital","Seoul","03080",{"type":47,"coordinates":1207},[1208,1209],126.9784,37.566,{"lat":1209,"lon":1208},{"facility":1212,"status":37,"city":1204,"state":37,"zip":1213,"country":1196,"countryCode":37,"cosmosGeoPoint":1214,"geoPoint":1216,"contacts":37},"Asan Medical Center","05505",{"type":47,"coordinates":1215},[1208,1209],{"lat":1209,"lon":1208},{"facility":1218,"status":37,"city":1204,"state":37,"zip":1219,"country":1196,"countryCode":37,"cosmosGeoPoint":1220,"geoPoint":1222,"contacts":37},"Samsung Medical Center","06351",{"type":47,"coordinates":1221},[1208,1209],{"lat":1209,"lon":1208},{"facility":1224,"status":37,"city":1225,"state":1226,"zip":1227,"country":1228,"countryCode":1229,"cosmosGeoPoint":1230,"geoPoint":1234,"contacts":37},"Institut Catala d?Oncologia Hospital Germans Trias i Pujol","Badalona","Barcelona","08916","Spain","ES",{"type":47,"coordinates":1231},[1232,1233],2.24741,41.45004,{"lat":1233,"lon":1232},{"facility":1236,"status":37,"city":1237,"state":1226,"zip":1238,"country":1228,"countryCode":1229,"cosmosGeoPoint":1239,"geoPoint":1243,"contacts":37},"Insititut Catala D'Oncologia","L'Hospitalet de Llobregat","08908",{"type":47,"coordinates":1240},[1241,1242],2.10028,41.35967,{"lat":1242,"lon":1241},{"facility":1245,"status":37,"city":1246,"state":1226,"zip":1247,"country":1228,"countryCode":1229,"cosmosGeoPoint":1248,"geoPoint":1252,"contacts":37},"Corporacio Sanitaria Parc Tauli; Servicio de Oncologia","Sabadell","8208",{"type":47,"coordinates":1249},[1250,1251],2.10942,41.54329,{"lat":1251,"lon":1250},{"facility":1254,"status":37,"city":1255,"state":1256,"zip":1257,"country":1228,"countryCode":1229,"cosmosGeoPoint":1258,"geoPoint":1262,"contacts":37},"Hospital Universitario Reina Sofia; Servicio de Oncologia","Córdoba","Cordoba","14004",{"type":47,"coordinates":1259},[1260,1261],-4.77275,37.89155,{"lat":1261,"lon":1260},{"facility":1264,"status":37,"city":1265,"state":1266,"zip":1267,"country":1228,"countryCode":1229,"cosmosGeoPoint":1268,"geoPoint":1272,"contacts":37},"Clinica Universitaria de Navarra; Servicio de Oncologia","Pamplona","Navarre","31008",{"type":47,"coordinates":1269},[1270,1271],-1.64323,42.81687,{"lat":1271,"lon":1270},{"facility":1274,"status":37,"city":1226,"state":37,"zip":1275,"country":1228,"countryCode":1229,"cosmosGeoPoint":1276,"geoPoint":1280,"contacts":37},"Hospital Universitari Vall d'Hebron; Oncology","08035",{"type":47,"coordinates":1277},[1278,1279],2.15899,41.38879,{"lat":1279,"lon":1278},{"facility":1282,"status":37,"city":1226,"state":37,"zip":1283,"country":1228,"countryCode":1229,"cosmosGeoPoint":1284,"geoPoint":1286,"contacts":37},"Hospital Clínic i Provincial; Servicio de Oncología","08036",{"type":47,"coordinates":1285},[1278,1279],{"lat":1279,"lon":1278},{"facility":1288,"status":37,"city":1226,"state":37,"zip":1289,"country":1228,"countryCode":1229,"cosmosGeoPoint":1290,"geoPoint":1292,"contacts":37},"Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia","08041",{"type":47,"coordinates":1291},[1278,1279],{"lat":1279,"lon":1278},{"facility":1294,"status":37,"city":1295,"state":37,"zip":1296,"country":1228,"countryCode":1229,"cosmosGeoPoint":1297,"geoPoint":1301,"contacts":37},"Hospital Ramon y Cajal; Servicio de Oncologia","Madrid","28034",{"type":47,"coordinates":1298},[1299,1300],-3.70256,40.4165,{"lat":1300,"lon":1299},{"facility":1303,"status":37,"city":1295,"state":37,"zip":1304,"country":1228,"countryCode":1229,"cosmosGeoPoint":1305,"geoPoint":1307,"contacts":37},"Hospital Clinico San Carlos; Servicio de Oncologia","28040",{"type":47,"coordinates":1306},[1299,1300],{"lat":1300,"lon":1299},{"facility":1309,"status":37,"city":1295,"state":37,"zip":1310,"country":1228,"countryCode":1229,"cosmosGeoPoint":1311,"geoPoint":1313,"contacts":37},"Hospital Universitario 12 de Octubre; Servicio de Oncologia","28041",{"type":47,"coordinates":1312},[1299,1300],{"lat":1300,"lon":1299},{"facility":1315,"status":37,"city":1316,"state":37,"zip":1317,"country":1228,"countryCode":1229,"cosmosGeoPoint":1318,"geoPoint":1322,"contacts":37},"Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia","Málaga","29010",{"type":47,"coordinates":1319},[1320,1321],-4.42034,36.72016,{"lat":1321,"lon":1320},{"facility":1324,"status":37,"city":1325,"state":37,"zip":1326,"country":1228,"countryCode":1229,"cosmosGeoPoint":1327,"geoPoint":1331,"contacts":37},"Hospital Universitario Virgen del Rocio; Servicio de Oncologia","Seville","41013",{"type":47,"coordinates":1328},[1329,1330],-5.97317,37.38283,{"lat":1330,"lon":1329},{"facility":1333,"status":37,"city":1334,"state":37,"zip":1335,"country":1336,"countryCode":1337,"cosmosGeoPoint":1338,"geoPoint":1342,"contacts":37},"Inselspital Bern; Universitätsklinik für Medizinische Onkologie, Klinische Forschungseinheit","Bern","3010","Switzerland","CH",{"type":47,"coordinates":1339},[1340,1341],7.44744,46.94809,{"lat":1341,"lon":1340},{"facility":1344,"status":37,"city":1345,"state":37,"zip":1346,"country":1336,"countryCode":1337,"cosmosGeoPoint":1347,"geoPoint":1351,"contacts":37},"Kantonsspital St. Gallen; Onkologie\u002FHämatologie","Sankt Gallen","9007",{"type":47,"coordinates":1348},[1349,1350],9.37477,47.42391,{"lat":1350,"lon":1349},{"facility":1353,"status":37,"city":1354,"state":37,"zip":1355,"country":1356,"countryCode":1357,"cosmosGeoPoint":1358,"geoPoint":1362,"contacts":37},"Taichung Veterans General Hospital; Division of Urology","Taichung","407","Taiwan","TW",{"type":47,"coordinates":1359},[1360,1361],120.6839,24.1469,{"lat":1361,"lon":1360},{"facility":1364,"status":37,"city":1365,"state":37,"zip":1366,"country":1356,"countryCode":1357,"cosmosGeoPoint":1367,"geoPoint":1371,"contacts":37},"National Taiwan University Hospital, Department of Urology","Taipei","10048",{"type":47,"coordinates":1368},[1369,1370],121.52639,25.05306,{"lat":1370,"lon":1369},{"facility":1373,"status":37,"city":1365,"state":37,"zip":1374,"country":1356,"countryCode":1357,"cosmosGeoPoint":1375,"geoPoint":1377,"contacts":37},"TAIPEI VETERANS GENERAL HOSPITAL, Urology","11217",{"type":47,"coordinates":1376},[1369,1370],{"lat":1370,"lon":1369},{"facility":1379,"status":37,"city":1380,"state":37,"zip":1381,"country":1356,"countryCode":1357,"cosmosGeoPoint":1382,"geoPoint":1386,"contacts":37},"Chang Gung Memorial Hospital-LinKou; Urology","Taoyuan","333",{"type":47,"coordinates":1383},[1384,1385],121.29696,24.99368,{"lat":1385,"lon":1384},{"facility":1388,"status":37,"city":1389,"state":37,"zip":1390,"country":1391,"countryCode":1392,"cosmosGeoPoint":1393,"geoPoint":1397,"contacts":37},"Royal Blackburn Hospital","Blackburn","BB2 3HH","United Kingdom","UK",{"type":47,"coordinates":1394},[1395,1396],-2.48333,53.75,{"lat":1396,"lon":1395},{"facility":1399,"status":37,"city":1400,"state":37,"zip":1401,"country":1391,"countryCode":1392,"cosmosGeoPoint":1402,"geoPoint":1406,"contacts":37},"Leicester Royal Infirmary","Leicester","LE1 5WW",{"type":47,"coordinates":1403},[1404,1405],-1.13169,52.6386,{"lat":1405,"lon":1404},{"facility":1408,"status":37,"city":1409,"state":37,"zip":1410,"country":1391,"countryCode":1392,"cosmosGeoPoint":1411,"geoPoint":1415,"contacts":37},"Barts and the London NHS Trust.","London","EC1A 7BE",{"type":47,"coordinates":1412},[1413,1414],-0.12574,51.50853,{"lat":1414,"lon":1413},{"facility":1417,"status":37,"city":1409,"state":37,"zip":1418,"country":1391,"countryCode":1392,"cosmosGeoPoint":1419,"geoPoint":1421,"contacts":37},"Sarah Cannon Research Institute","W1G 6AD",{"type":47,"coordinates":1420},[1413,1414],{"lat":1414,"lon":1413},{"facility":1423,"status":37,"city":1424,"state":37,"zip":1425,"country":1391,"countryCode":1392,"cosmosGeoPoint":1426,"geoPoint":1430,"contacts":37},"The Christie NHS Foundation Trust","Manchester","M20 4BX",{"type":47,"coordinates":1427},[1428,1429],-2.23743,53.48095,{"lat":1429,"lon":1428},{"facility":1432,"status":37,"city":1433,"state":37,"zip":1434,"country":1391,"countryCode":1392,"cosmosGeoPoint":1435,"geoPoint":1439,"contacts":37},"Royal Marsden Hospital; Institute of Cancer Research","Sutton","SM2 5PT",{"type":47,"coordinates":1436},[1437,1438],-0.2,51.35,{"lat":1438,"lon":1437},{"type":1441,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100287027","phase-3-a-study-of-atezolizumab-anti-pd-l1-antibody-in-combination-with-enzalutamide-in-participants-with-metastatic-castration-resistant-prostrate-cancer-mcrpc-after-failure-of-an-androgen-synthesis-inhibitor-and-failure-of-ineligibility-for-or-refusal-of-a-taxane-regimen-100287027",true,"NCT03016312","A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen","A Phase III, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostate Cancer After Failure of an Androgen Synthesis Inhibitor and Failure of, Ineligibility for, or Refusal of a Taxane Regimen","IMbassador250","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Life expectancy greater than or equal to (\\>\u002F=) 3 months\n* Histologically confirmed adenocarcinoma of the prostate\n* Known castrate-resistant disease with serum testosterone level less than or equal to (\\\u003C\u002F=) 50 nanograms per deciliter (ng\u002FdL) with prior surgical castration or ongoing androgen deprivation for the duration of the study\n* Progressive disease prior to screening by PSA or imaging per PCWG3 criteria during or following the direct prior line of therapy in the setting of medical or surgical castration\n* One prior regimen\u002Fline of a taxane-containing regimen for mCRPC or refusal or ineligibility of a taxane-containing regimen\n* Progression on a prior regimen\u002Fline of an androgen synthesis inhibitor for prostate cancer\n* Availability of a representative tumor specimen from a site not previously irradiated that is suitable for determination of programmed death-ligand 1 (PD-L1) status via central testing\n* Adequate hematologic and end organ function\n\nExclusion Criteria:\n\n* Prior treatment with enzalutamide or any other newer hormonal androgen receptor inhibitor (e.g., apalutamide, ODM-201)\n* Treatment with any approved anti-cancer therapy, including chemotherapy, immunotherapy, radiopharmaceutical or hormonal therapy (with the exception of abiraterone), within 4 weeks prior to initiation of study treatment\n* Treatment with abiraterone within 2 weeks prior to study treatment\n* Structurally unstable bone lesions suggesting impending fracture\n* Known or suspected brain metastasis or active leptomeningeal disease\n* Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study\n* Active or history of autoimmune disease or immune deficiency\n* Prior allogeneic stem cell or solid organ transplantation\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan\n* Positive human immunodeficiency virus (HIV) test, active tuberculosis, active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection\n* Prior treatment with cluster of differentiation (CD)137 agonists or immune checkpoint blockade therapies, including anti Cytotoxic T Lymphocyte-Associated 4 (CTLA4), anti-programmed death 1 (PD-1), and anti-PD-L1 therapeutic antibodies\n* Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study\n* History of seizure or any condition that may predispose to seizure within 12 months prior to study treatment, including history of unexplained loss of consciousness or transient ischemic attack",false,"MALE","18 Years",{"count":1454,"type":1455},759,"ACTUAL","INTERVENTIONAL",[1458],"PHASE3","This Phase III, multicenter, randomized, open-label study will evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 \\[anti-PD-L1\\] antibody) in combination with enzalutamide compared with enzalutamide alone in participants with mCRPC after failure of an androgen synthesis inhibitor (e.g., abiraterone) and failure of, ineligibility for, or refusal of a taxane regimen. Participants will be randomized to one of the two treatment arms (atezolizumab in combination with enzalutamide, and enzalutamide alone) in a 1:1 ratio (experimental to control arm) in global randomized phase. Participants will receive treatment until investigator-assessed confirmed radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity.",[1461],"Prostatic Neoplasms, Castration-Resistant","COMPLETED","2024-08-08",{"date":1465,"type":1455},"2024-08-09",{"date":1467,"type":1455},"2017-01-10",{"date":1469,"type":1455},"2022-12-20",{"name":5,"class":6},158]