[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100270023":3},{"organization":4,"armGroups":7,"interventions":67,"overallOfficials":117,"centralContacts":88,"locations":122,"responsibleParty":388,"collaborators":88,"id":390,"slug":391,"hasResults":392,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":88,"eligibilityCriteria":396,"healthyVolunteers":392,"sex":397,"minAge":398,"maxAge":88,"enrollmentInfo":399,"targetDuration":88,"studyType":402,"phases":403,"briefSummary":405,"conditions":406,"keywords":88,"overallStatus":408,"whyStopped":88,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":417},{"fullName":5,"class":6},"Genentech, Inc.","INDUSTRY",[8,14,18,23,27,34,39,44,49,53,57,62],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase Ia Dose-Escalation Stage: Tiragolumab","EXPERIMENTAL","Cohorts of at least 3 participants each will be treated with escalating doses of tiragolumab.",[13],"Drug: Tiragolumab",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase Ia Dose-Expansion Stage: Tiragolumab","Participants will be treated with tiragolumab at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD) in the study.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Phase Ib Q3W Dose-Escalation Stage: Tiragolumab+Atezolizumab","A minimum of 3 participants will be treated for each dose level of tiragolumab in combination with a fixed dose of atezolizumab with tiragolumab being administered prior to atezolizumab.",[22,13],"Drug: Atezolizumab",{"label":24,"type":10,"description":25,"interventionNames":26},"Phase Ib Q3W Dose-Expansion Stage: Tiragolumab+Atezolizumab","Participants will be treated every 3 weeks (Q3W) with tiragolumab at or below the MTD or MAD in combination with a fixed dose of atezolizumab with tiragolumab being administered prior to atezolizumab.",[22,13],{"label":28,"type":10,"description":29,"interventionNames":30},"Phase Ib Chemotherapy Dose-Expansion Stage: Cohort A","In Cohort A, carboplatin or cisplatin and pemetrexed chemotherapy will be administered after atezolizumab and tiragolumab intravenous (IV) infusion. During induction phase, participants will receive atezolizumab and tiragolumab in combination with carboplatin or cisplatin and pemetrexed on Day 1 of each 21-day cycle for 4 to 6 cycles. During maintenance phase, participants will receive atezolizumab and tiragolumab in combination with pemetrexed on Day 1 of each 21-day cycle.",[22,13,31,32,33],"Drug: Carboplatin","Drug: Cisplatin","Drug: Pemetrexed",{"label":35,"type":10,"description":36,"interventionNames":37},"Phase Ib Chemotherapy Dose-Expansion Stage: Cohort B","In Cohort B, carboplatin and paclitaxel chemotherapy will be administered after atezolizumab and tiragolumab IV infusion. During induction phase, participants will receive atezolizumab and tiragolumab in combination with carboplatin and paclitaxel on Day 1 of each 21-day cycle for 4 to 6 cycles. During maintenance phase, participants will receive atezolizumab and tiragolumab on Day 1 of each 21-day cycle (participants enrolled under protocol version 4) or Day 1 of each 28-day cycle (participants enrolled under protocol version 5).",[22,13,31,38],"Drug: Paclitaxel",{"label":40,"type":10,"description":41,"interventionNames":42},"Phase Ib Chemotherapy Dose-Expansion Stage: Cohort C","In Cohort C, carboplatin or cisplatin and etoposide chemotherapy will be administered after atezolizumab and tiragolumab IV infusion. During induction phase, participants will receive atezolizumab and tiragolumab in combination with carboplatin or cisplatin on Day 1 of each 21-day cycle and etoposide on Day 1 to 3 of each 21-day cycle for 4 cycles. During maintenance phase, participants will receive atezolizumab and tiragolumab on Day 1 of each 28-day cycle.",[22,13,31,32,43],"Drug: Etoposide",{"label":45,"type":10,"description":46,"interventionNames":47},"Phase Ib Chemotherapy Dose-Expansion Stage: Cohort D","In Cohort D, participants will receive atezolizumab and tiragolumab on Day 1 and capecitabine on Day 1-14 of each 21-day cycle.",[22,13,48],"Drug: Capecitabine",{"label":50,"type":10,"description":51,"interventionNames":52},"Phase Ib Q4W Sequential Dose-Expansion Stage: Tiragolumab+Atezolizumab","Participants will be treated every 4 weeks (Q4W) with fixed doses of tiragolumab and atezolizumab with tiragolumab being administered prior to atezolizumab.",[22,13],{"label":54,"type":10,"description":55,"interventionNames":56},"Phase Ib Q4W Coinfusion Expansion Cohort Tiragolumab+Atezolizumab","Participants will be treated Q4W with fixed doses of tiragolumab and atezolizumab mixed and administered in one IV bag.",[22,13],{"label":58,"type":10,"description":59,"interventionNames":60},"Phase Ib Non-Chemotherapy Dose-Expansion Stage: Cohort NC1","In Cohort NC1, participants will receive atezolizumab and tiragolumab in combination with bevacizumab on Day 1 of each 21-day cycle.",[22,13,61],"Drug: Bevacizumab",{"label":63,"type":10,"description":64,"interventionNames":65},"Phase Ib Non-Chemotherapy Dose-Expansion Stage: Cohort NC2","In Cohort NC2, participants will receive tiragolumab in combination with pembrolizumab on Day 1 of each 21-day cycle.",[13,66],"Drug: Pembrolizumab",[68,77,84,89,93,97,101,105,109,113],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"DRUG","Atezolizumab","Atezolizumab will be given as 1200 mg via IV infusion on Day 1 of each 21-day cycle or as 1680 mg via IV infusion on Day 1 of each 28-day cycle.",[28,35,40,45,58,19,24,54,50],[74,75,76],"MPDL3280A","RO5541267","Tecentriq",{"type":69,"name":78,"description":79,"armGroupLabels":80,"otherNames":81},"Tiragolumab","Several dose levels will be evaluated for tiragolumab administered as a single agent and in combination with atezolizumab and\u002For other anti-cancer therapies. Tiragolumab will be given via IV infusion on Day 1 of each cycle (21-day or 28-day depending on study cohort and phase) until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent tiragolumab may receive combination treatment with tiragolumab and atezolizumab and\u002For other anti-cancer therapies. Combination treatment may continue until disease progression or loss of clinical benefit.",[9,15,28,35,40,45,58,63,19,24,54,50],[82,83],"MTIG7192A","RO7092284",{"type":69,"name":85,"description":86,"armGroupLabels":87,"otherNames":88},"Carboplatin","Carboplatin, AUC of 6 milligram per milliliter per minute (mg\u002Fml\u002Fmin) for Cohorts A and B and AUC of 5 mg\u002Fml\u002Fmin for Cohort C, IV infusion will be administered on Day 1 of each 21-day cycle after combination treatment of atezolizumab and tiragolumab IV infusion.",[28,35,40],null,{"type":69,"name":90,"description":91,"armGroupLabels":92,"otherNames":88},"Cisplatin","Cisplatin 75 milligram per square meter (mg\u002Fm\\^2) IV infusion will be administered on day 1 of each 21-day cycle after combination treatment of atezolizumab and tiragolumab.",[28,40],{"type":69,"name":94,"description":95,"armGroupLabels":96,"otherNames":88},"Pemetrexed","Pemetrexed 500 mg\u002Fm\\^2 IV infusion will be administered on Day 1 of each 21-day cycle after carboplatin or cisplatin IV infusion with combination treatment of atezolizumab and tiragolumab.",[28],{"type":69,"name":98,"description":99,"armGroupLabels":100,"otherNames":88},"Paclitaxel","Paclitaxel 200 mg\u002Fm\\^2 IV infusion will be administered on Day 1 of each 21-day cycle after combination treatment with atezolizumab and tiragolumab.",[35],{"type":69,"name":102,"description":103,"armGroupLabels":104,"otherNames":88},"Etoposide","Etoposide 100 mg\u002Fm\\^2 IV infusion will be administered on Days 1, 2, and 3 of each 21-day cycle with combination treatment of atezolizumab and tiragolumab.",[40],{"type":69,"name":106,"description":107,"armGroupLabels":108,"otherNames":88},"Capecitabine","Capecitabine 1250 mg\u002Fm\\^2 oral dose will be administered twice daily (BID) on Days 1 through 14 of each 21-day cycle. On Day 1 of Cycle 1, the first dose of capecitabine will be administered prior to the atezolizumab and tiragolumab infusion.",[45],{"type":69,"name":110,"description":111,"armGroupLabels":112,"otherNames":88},"Bevacizumab","Bevacizumab 15 mg\u002Fkg IV infusion will be administered on Day 1 of each 21-day cycle after combination treatment of atezolizumab and tiragolumab.",[58],{"type":69,"name":114,"description":115,"armGroupLabels":116,"otherNames":88},"Pembrolizumab","Pembrolizumab 200 mg IV infusion will be administered on Day 1 of each 21-day cycle after treatment with tiragolumab.",[63],[118],{"name":119,"affiliation":120,"role":121},"Clinical Trials","Hoffmann-La Roche","STUDY_DIRECTOR",[123,136,146,156,166,176,186,195,205,217,227,239,250,259,268,277,286,297,303,313,319,325,331,343,352,362,370,379],{"facility":124,"status":88,"city":125,"state":126,"zip":127,"country":128,"countryCode":129,"cosmosGeoPoint":130,"geoPoint":135,"contacts":88},"Honor Health Research Institute","Scottsdale","Arizona","85258","United States","US",{"type":131,"coordinates":132},"Point",[133,134],-111.89903,33.50921,{"lat":134,"lon":133},{"facility":137,"status":88,"city":138,"state":139,"zip":140,"country":128,"countryCode":129,"cosmosGeoPoint":141,"geoPoint":145,"contacts":88},"University of California Los Angeles","Santa Monica","California","90404",{"type":131,"coordinates":142},[143,144],-118.49138,34.01949,{"lat":144,"lon":143},{"facility":147,"status":88,"city":148,"state":149,"zip":150,"country":128,"countryCode":129,"cosmosGeoPoint":151,"geoPoint":155,"contacts":88},"Yale Cancer Center","New Haven","Connecticut","06520",{"type":131,"coordinates":152},[153,154],-72.92816,41.30815,{"lat":154,"lon":153},{"facility":157,"status":88,"city":158,"state":159,"zip":160,"country":128,"countryCode":129,"cosmosGeoPoint":161,"geoPoint":165,"contacts":88},"Johns Hopkins Sidney Kimmel Comprehensive Cancer Center","Baltimore","Maryland","21287",{"type":131,"coordinates":162},[163,164],-76.61219,39.29038,{"lat":164,"lon":163},{"facility":167,"status":88,"city":168,"state":169,"zip":170,"country":128,"countryCode":129,"cosmosGeoPoint":171,"geoPoint":175,"contacts":88},"Dana Farber Cancer Institute","Boston","Massachusetts","02215",{"type":131,"coordinates":172},[173,174],-71.05977,42.35843,{"lat":174,"lon":173},{"facility":177,"status":88,"city":178,"state":179,"zip":180,"country":128,"countryCode":129,"cosmosGeoPoint":181,"geoPoint":185,"contacts":88},"Henry Ford Hospital","Detroit","Michigan","48202",{"type":131,"coordinates":182},[183,184],-83.04575,42.33143,{"lat":184,"lon":183},{"facility":187,"status":88,"city":188,"state":188,"zip":189,"country":128,"countryCode":129,"cosmosGeoPoint":190,"geoPoint":194,"contacts":88},"Memorial Sloan-Kettering Cancer Center","New York","10065",{"type":131,"coordinates":191},[192,193],-74.00597,40.71427,{"lat":193,"lon":192},{"facility":196,"status":88,"city":197,"state":198,"zip":199,"country":128,"countryCode":129,"cosmosGeoPoint":200,"geoPoint":204,"contacts":88},"Tennessee Oncology - Nashville","Nashville","Tennessee","37203",{"type":131,"coordinates":201},[202,203],-86.78444,36.16589,{"lat":203,"lon":202},{"facility":206,"status":88,"city":207,"state":208,"zip":209,"country":210,"countryCode":211,"cosmosGeoPoint":212,"geoPoint":216,"contacts":88},"Kinghorn Cancer Centre; St Vincents Hospital","Darlinghurst","New South Wales","2010","Australia","AU",{"type":131,"coordinates":213},[214,215],151.21925,-33.87939,{"lat":215,"lon":214},{"facility":218,"status":88,"city":219,"state":220,"zip":221,"country":210,"countryCode":211,"cosmosGeoPoint":222,"geoPoint":226,"contacts":88},"Peter MacCallum Cancer Center","North Melbourne","Victoria","3051",{"type":131,"coordinates":223},[224,225],144.94512,-37.79798,{"lat":225,"lon":224},{"facility":228,"status":88,"city":229,"state":230,"zip":231,"country":232,"countryCode":233,"cosmosGeoPoint":234,"geoPoint":238,"contacts":88},"Princess Margaret Hospital","Toronto","Ontario","M4X 1K9","Canada","CA",{"type":131,"coordinates":235},[236,237],-79.39864,43.70643,{"lat":237,"lon":236},{"facility":240,"status":88,"city":241,"state":88,"zip":242,"country":243,"countryCode":244,"cosmosGeoPoint":245,"geoPoint":249,"contacts":88},"Institut Bergonie CLCC Bordeaux","Bordeaux","33000","France","FR",{"type":131,"coordinates":246},[247,248],-0.58046,44.84124,{"lat":248,"lon":247},{"facility":251,"status":88,"city":252,"state":88,"zip":253,"country":243,"countryCode":244,"cosmosGeoPoint":254,"geoPoint":258,"contacts":88},"Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes","Lyon","69008",{"type":131,"coordinates":255},[256,257],4.84789,45.74906,{"lat":257,"lon":256},{"facility":260,"status":88,"city":261,"state":88,"zip":262,"country":243,"countryCode":244,"cosmosGeoPoint":263,"geoPoint":267,"contacts":88},"Institut Curie","Paris","75005",{"type":131,"coordinates":264},[265,266],2.3488,48.85341,{"lat":266,"lon":265},{"facility":269,"status":88,"city":270,"state":88,"zip":271,"country":243,"countryCode":244,"cosmosGeoPoint":272,"geoPoint":276,"contacts":88},"Institut Claudius Regaud; Departement Oncologie Medicale","Toulouse","31059",{"type":131,"coordinates":273},[274,275],1.44367,43.60426,{"lat":275,"lon":274},{"facility":278,"status":88,"city":279,"state":88,"zip":280,"country":243,"countryCode":244,"cosmosGeoPoint":281,"geoPoint":285,"contacts":88},"Institut Gustave Roussy","Villejuif","94805",{"type":131,"coordinates":282},[283,284],2.35992,48.7939,{"lat":284,"lon":283},{"facility":287,"status":88,"city":288,"state":88,"zip":289,"country":290,"countryCode":291,"cosmosGeoPoint":292,"geoPoint":296,"contacts":88},"National Cancer Center Hospital","Tokyo","104-0045","Japan","JP",{"type":131,"coordinates":293},[294,295],139.69171,35.6895,{"lat":295,"lon":294},{"facility":298,"status":88,"city":288,"state":88,"zip":299,"country":290,"countryCode":291,"cosmosGeoPoint":300,"geoPoint":302,"contacts":88},"The Cancer Institute Hospital of Japanese Foundation For Cancer Research","135-8550",{"type":131,"coordinates":301},[294,295],{"lat":295,"lon":294},{"facility":304,"status":88,"city":305,"state":88,"zip":306,"country":307,"countryCode":88,"cosmosGeoPoint":308,"geoPoint":312,"contacts":88},"Seoul National University Hospital","Seoul","03080","South Korea",{"type":131,"coordinates":309},[310,311],126.9784,37.566,{"lat":311,"lon":310},{"facility":314,"status":88,"city":305,"state":88,"zip":315,"country":307,"countryCode":88,"cosmosGeoPoint":316,"geoPoint":318,"contacts":88},"Severance Hospital, Yonsei University Health System","03722",{"type":131,"coordinates":317},[310,311],{"lat":311,"lon":310},{"facility":320,"status":88,"city":305,"state":88,"zip":321,"country":307,"countryCode":88,"cosmosGeoPoint":322,"geoPoint":324,"contacts":88},"Asan Medical Center","05505",{"type":131,"coordinates":323},[310,311],{"lat":311,"lon":310},{"facility":326,"status":88,"city":305,"state":88,"zip":327,"country":307,"countryCode":88,"cosmosGeoPoint":328,"geoPoint":330,"contacts":88},"Samsung Medical Center","06351",{"type":131,"coordinates":329},[310,311],{"lat":311,"lon":310},{"facility":332,"status":88,"city":333,"state":334,"zip":335,"country":336,"countryCode":337,"cosmosGeoPoint":338,"geoPoint":342,"contacts":88},"ICO L'Hospitalet; Servicio de oncologia medica","L'Hospitalet de Llobregat","Barcelona","08908","Spain","ES",{"type":131,"coordinates":339},[340,341],2.10028,41.35967,{"lat":341,"lon":340},{"facility":344,"status":88,"city":345,"state":334,"zip":346,"country":336,"countryCode":337,"cosmosGeoPoint":347,"geoPoint":351,"contacts":88},"Hospital Univ Vall d'Hebron; Servicio de Oncologia","Sant Andreu de la Barca","08740",{"type":131,"coordinates":348},[349,350],1.97187,41.44659,{"lat":350,"lon":349},{"facility":353,"status":88,"city":354,"state":355,"zip":356,"country":336,"countryCode":337,"cosmosGeoPoint":357,"geoPoint":361,"contacts":88},"Clinica Universitaria de Navarra; Servicio de oncología","Pamplona","Navarre","31008",{"type":131,"coordinates":358},[359,360],-1.64323,42.81687,{"lat":360,"lon":359},{"facility":363,"status":88,"city":334,"state":88,"zip":364,"country":336,"countryCode":337,"cosmosGeoPoint":365,"geoPoint":369,"contacts":88},"Hospital del Mar","08003",{"type":131,"coordinates":366},[367,368],2.15899,41.38879,{"lat":368,"lon":367},{"facility":371,"status":88,"city":372,"state":88,"zip":373,"country":336,"countryCode":337,"cosmosGeoPoint":374,"geoPoint":378,"contacts":88},"Hospital Universitario HM Sanchinarro-CIOCC; Oncología Médica","Madrid","28050",{"type":131,"coordinates":375},[376,377],-3.70256,40.4165,{"lat":377,"lon":376},{"facility":380,"status":88,"city":381,"state":88,"zip":382,"country":336,"countryCode":337,"cosmosGeoPoint":383,"geoPoint":387,"contacts":88},"Hospital Clinico Universitario de Valencia","Valencia","46010",{"type":131,"coordinates":384},[385,386],-0.37966,39.47391,{"lat":386,"lon":385},{"type":389,"investigatorFullName":88,"investigatorTitle":88,"investigatorAffiliation":88,"oldNameTitle":88,"oldOrganization":88},"SPONSOR","100270023","phase-1-safety-and-pharmacokinetics-pk-of-escalating-doses-of-tiragolumab-as-a-single-agent-and-in-combination-with-atezolizumab-andor-other-anti-cancer-therapies-in-locally-advanced-or-metastatic-tumors-100270023",false,"NCT02794571","Safety and Pharmacokinetics (PK) of Escalating Doses of Tiragolumab as a Single Agent and in Combination With Atezolizumab and\u002For Other Anti-Cancer Therapies in Locally Advanced or Metastatic Tumors","A Phase Ia\u002FIb Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Tiragolumab as a Single Agent and in Combination With Atezolizumab and\u002For Other Anti-Cancer Therapies in Patients With Locally Advanced or Metastatic Tumors","Inclusion Criteria:\n\n* Adults 18 years of age or older\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Life expectancy at least 12 weeks\n* Adequate hematologic and end organ function\n* Histologic documentation of locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for which standard therapy has proven ineffective, intolerable, or considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care\n* Confirmed availability of representative tumor specimens\n* Measurable disease according to RECIST Version 1.1\n\nExclusion Criteria:\n\n* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment\n* Malignancies other than disease under study within 5 years prior to Day 1 of Cycle 1\n* Primary central nervous system (CNS) malignancy, or untreated\u002Factive CNS metastases\n* Leptomeningeal disease\n* History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on Screening chest computed tomograph (CT) scan\n* History of autoimmune disease\n* Positive human immunodeficiency virus (HIV) test\n* Active hepatitis B or C, or tuberculosis\n* Severe infection within 4 weeks prior to randomization\n* Prior allogeneic bone marrow or solid organ transplant\n* Significant cardiovascular disease\n* Known clinically significant liver disease","ALL","18 Years",{"count":400,"type":401},518,"ACTUAL","INTERVENTIONAL",[404],"PHASE1","This first-in-human open-label, multicenter, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and PK of tiragolumab alone or in combination with atezolizumab and\u002For other anti-cancer therapies in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable, or is considered inappropriate, or for whom a clinical trial of an investigational agent is a recognized standard of care.",[407],"Advanced\u002FMetastatic Tumors","COMPLETED","2024-12-04",{"date":411,"type":401},"2024-12-05",{"date":413,"type":401},"2016-05-23",{"date":415,"type":401},"2024-11-13",{"name":5,"class":6},28]