a study of atezolizumab (anti−pd-l1 antibody) as adjuvant ... filea study of atezolizumab...

A Study of Atezolizumab (Anti−Pd-L1 Antibody) as Adjuvant Therapy After Definitive Local Therapy in Patients With High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and NeckNCT-Nummer:NCT03452137

Studienbeginn:April 2018

Letztes Update:22.07.2019

Wirkstoff:Atezolizumab, PlaceboIndikation (Clinical Trials):Carcinoma, Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck

Geschlecht:Alle

Altersgruppe:Erwachsene (18+)

Phase:Phase 3

Sponsor:Hoffmann-La Roche

Collaborator:-

Studien-InformationenBrief Summary:

This study will evaluate the efficacy and safety of atezolizumab compared with placebo as adjuvant therapy after definitive local therapy in patients with high-risk locally advanced

https://www.clinicaltrials.gov/show/NCT03452137

squamous cell carcinoma of the head and neck (SCCHN)

Ein-/AusschlusskriterienInclusion Criteria

- Histologically or cytologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN)

- Human Papilloma Virus (HPV) status

- Completed definitive local therapy

- Absence of metastatic disease as documented by radiographic scans

- Adequate hematologic and end-organ function

- For patients receiving therapeutic anticoagulation: stable anticoagulant regimen

- For women of childbearing potential: agreement to remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 5 months after the last dose of study treatment. Women must refrain from donating eggs during this same period.

- Confirmed response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) to definitive local therapy documented by CT with contrast or MRI with contract to head and neck region done >= 8 weeks after completion of definitive local therapy and within 28 days prior to initiation of study drug.

Exclusion Criteria:

- Patients who have received surgery alone or radiotherapy alone as definitive local therapy

- Squamous cell carcinoma of the nasopharynx or paranasal sinuses or non-squamous histology

- Evidence of disease progression or metastatic disease during or following definitive local therapy documented in post-definitive local therapy screening scans

- Uncontrolled or symptomatic hypercalcemia

- Active or history of autoimmune disease or immune deficiency

- Active tuberculosis

- Significant cardiovascular disease

- History of malignancy, including prior SCCHN primary tumors within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death

- Prior allogeneic stem cell or solid organ transplantation

- Current treatment with anti-viral therapy for Hepatitis B Virus (HBV)

- Treatment with systemic immunostimulatory agents

- Treatment with systemic immunosuppressive medication

- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins

- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the last dose of study treatment

- Patients who have received a non-FDA or non-EMA approved anti-EGFR agent or any other non-FDA or non-EMA, approved agent as part of definitive local therapy, unless the unapproved agent was given in addition to an approved agent

- Any systemic therapies after permitted definitive local therapies

Studien-RationalePrimary outcome:

1. Independent Review Facility assessed Event Free Survival (IRF assessed EFS) (Time Frame - Randomization to the first documented disease recurrence, or disease progression (per Response Evaluation Criteria In Solid Tumors (RECIST v1.1)), or death from any cause, whichever occurs first, through the end of study (approximately 65 months))

2. Overall Survival (OS) after Randomization (Time Frame - Randomization to death from any cause, through the end of study (approximately 65 months))

Secondary outcome:

1. Investigator Assessed Event Free Survival (EFS) (Time Frame - Randomization to the first documented disease recurrence, or disease progression (per RECIST v1.1) or death from any cause, whichever occurs first, through the end of study (approximately 65 months))

2. Percentage of Participants with Adverse Events (Time Frame - Baseline until up to 90 days after end of treatment (approximately 65 months))

3. Serum Concentration of Atezolizumab (Time Frame - At pre-defined intervals from Cycle 1, Day 1, through end of treatment (approximately 1 year).)

4. Change from baseline in physical function and Quality of Life Global Health Status/Quality of Life Scales of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (Time Frame - Baseline up until 30 days from last dose (approximately 65 months overall))

Studien-Arme

Active Comparator: AtezolizumabParticipants will receive Atezolizumab for 16 cycles, or up to 1 year (whichever occurs first)Experimental: PlaceboParticipants will receive Placebo for 16 cycles, or up to 1 year (whichever occurs first).

Geprüfte Regime

Atezolizumab:Atezolizumab intravenous infusion will be administered at a fixed dose on Day 1 of each 21-day cycle for 16 cycles.Placebo:Placebo intravenous infusion will be administered a fixed dose on Day 1 of each 21-day cycle for 16 cycles.

StudienleiterClinical TrialsStudy DirectorHoffmann-La Roche

KontaktReference Study ID Number: WO40242 www.roche.com/about_roche/roche_worldwide.htmKontakt:Phone: 888-662-6728 (U.S. and Canada)E-Mail: [email protected]

Studienlocations (3 von 188)Southern Cancer Center36526 DaphneUnited States

Status: Rekrutierend

University of Arizona85724-5030 TucsonUnited States

Status: Noch nicht rekrutierend

Kaiser Permanente - Bellflower90706 BellflowerUnited States


City of Hope National Medical Center91010 DuarteUnited States


University of California San Diego Medical Center; Moores Cancer Center92093 La JollaUnited States


University of Oklahoma90033 Los AngelesUnited States


UCLA Hematology/Oncology90404 Santa MonicaUnited States

Status: Aktiv, nicht rekrutierend

Kaiser Permanente - Vallejo94589 VallejoUnited States


Rocky Mountain Regional VA Medical Center80045 AuroraUnited States


Georgetown U; Lombardi Comp Can

20016-1468 WashingtonUnited States


Johns Hopkins Sidney Kimmel Cancer Center at Sibley Memorial Hospital20016 WashingtonUnited States

Status: Zurückgezogen

Miami Cancer Institute of Baptist Health, Inc.33176 MiamiUnited States


Woodlands Medical Specialists, P.A.32503 PensacolaUnited States


Winship Cancer Institute of Emory University30329 AtlantaUnited States


Northwest Georgia Oncology Centers30060 MariettaUnited States


Northwestern Medical Group/Northwestern University60611 ChicagoUnited States


Illinois Cancer Care61615 Peoria

United States


Cancer Center of Kansas67214-3728 WichitaUnited States


Maryland Oncology Hematology Columbia - USOR21044 ColumbiaUnited States


Dana-Farber Cancer Institute02215 BostonUnited States


Henry Ford Health System48202 DetroitUnited States


Billings Clinic Research Center59101 BillingsUnited States


Morristown Medical Center07962 MorristownUnited States


New York Oncology Hematology,P.C.-Albany12208 AlbanyUnited States


Cleveland Clinic; Taussig Cancer Institute44195 ClevelandUnited States


OSU, James Cancer Hospital43210 ColumbusUnited States


Fox Chase Cancer Center; Hematology/Oncology19111 PhiladelphiaUnited States


Blue Ridge Cancer Care24014 RoanokeUnited States


Northwest Cancer Specialists - Vancouver98684 VancouverUnited States

Status: Abgebrochen

St George Hospital2217 KogarahAustralia


Adelaide Cancer Centre5037 Kurralta ParkAustralia


Peter MacCallum Cancer Center3000 MelbourneAustralia


Sir Charles Gairdner Hospital6009 NedlandsAustralia


GHdC Site Notre Dame6000 CharleroiBelgium


UZ Antwerpen2650 EdegemBelgium


Clinique Ste-Elisabeth5000 NamurBelgium


Santa Casa de Misericordia de Salvador; Oncologia40050-410 SalvadorBrazil


Hospital do Cancer de Pernambuco - HCP50040-000 RecifeBrazil


Instituto Nacional do Cancer - INCA

20560-120 Rio de JaneiroBrazil


Hospital Sao Lucas - PUCRS90610-000 Porto AlegreBrazil


Hospital Nossa Senhora da Conceicao91350-200 Porto AlegreBrazil


CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia09060-650 Santo AndréBrazil


Instituto do Cancer do Estado de Sao Paulo - ICESP01246-000 Sao PauloBrazil


Cross Cancer InstituteT6G 1Z2 EdmontonCanada


Fraser Valley Centre British Columbia Cancer AgencyV3V 1Z2 SurreyCanada


Cancer Care ManitobaR3E 0V9 Winnipeg

Canada


London Health Sciences CentreN6A 4L6 LondonCanada


Beijing Cancer Hospital100142 BeijingChina


Xiangya Hospital of Centre-South University410008 ChangshaChina


West China Hospital, Sichuan University610041 ChengduChina


Fujian Cancer Hospital350014 FuzhouChina


The Second Affiliated Hospital of Zhejiang University School of Medicine310009 Hangzhou CityChina


Zhejiang Cancer Hospital310022 HangzhouChina


Harbin Medical University Cancer Hospital150081 HarbinChina


Jiangxi Cancer Hospital; First department of abdominal surgery330029 NanchangChina


Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine200011 ShanghaiChina


Fudan University Shanghai Cancer Center200032 ShanghaiChina


Shanghai East HospitalShanghaiChina


Tianjin Medical University General Hospital300052 Tianjin (天津)China


Union Hospital Tongji Medical College Huazhong University of Science and Technology430023 Wuhan CityChina


Institut Sainte Catherine84918 AvignonFrance


Centre Georges Francois Leclerc21000 DijonFrance


CENTRE LEON BERARD; Département d'Hématologie et d'Oncologie69373 LyonFrance


Hopital Timone Adultes; Oncologie Medicale Et Usp13385 MarseilleFrance


ICM; Radiotherapie34298 Montpellier Cedex 5France


Hopital Tenon; Oncologie Radiotherapie75970 ParisFrance


CHU Bordeaux33604 PessacFrance


Hôpitaux D'Instruction Des Armees Begin94160 St MandeFrance


Gustave Roussy Cancer Campus; Radiotherapie94805 VILLEJUIF CedexFrance


Charité - Campus Benjamin Franklin; Innere Medizin, Haematologie/Onkologie12203 Berlin(Berlin)Germany


Universitätsklinikum Bonn; Med. Klinik und Poliklinik III; Hämatologie, Onkologie und Rheumatologie53127 Bonn(Nordrhein-Westfalen)Germany


Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde79106 Freiburg(Baden-Württemberg)Germany


Universitätsklinikum Schleswig-Holstein; Klinik F. Strahlentherapie24105 Kiel(Schleswig-Holstein)Germany


Klinikum d. Uni. München; Campus Großhadern; Klinik und Poliklinik f. Strahlenthera. und Radioonko

81377 München(Bayern)Germany


Universitätsmedizin Rostock, Klinik und Poliklinik für Strahlentherapie; Zentrum für Radiologie18059 Rostock(Mecklenburg-Vorpommern)Germany


Orszagos Onkologial Intezet; Onkologiai Osztaly X1122 BudapestHungary


Uzsoki Utcai Korhaz1145 BudapestHungary


Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet7624 PecsHungary


Rajiv Gandhi Cancer Institute & Research Center110085 New DelhiIndia


Medanta-The Medicity122001 GurgaonIndia


Tata Memorial Hospital; Dept of Medical Oncology400012 MumbaiIndia


Max Super Speciality Hospital110017 New DelhiIndia


Istituto Nazionale Tumori Fondazione G. Pascale; S.C. Oncol. Medica Testa-Collo e Sarcoma80131 NapoliItaly


Ospedale Umberto I ASL di Ravenna Presidio Ospedaliero di LugoLugoItaly


IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica47014 MeldolaItaly


Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche00161 RomaItaly


Ospedale Civile; Servizio Oncologia17100 SavonaItaly


Spedali Civili di Brescia25123 BresciaItaly


Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo20133 MilanoItaly


Asst Santi Paolo E Carlo; Unita Operativa Di Oncologia Medica20142 MilanoItaly


Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia20089 RozzanoItaly


Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia50134 FirenzeItaly


IOV - Istituto Oncologico Veneto IRCCS35128 PadovaItaly


Aichi Cancer Center Hospital464-8681 AichiJapan


National Cancer Center Hospital East

277-8577 ChibaJapan


National Hospital Organization Kyushu Cancer Center811-1395 FukuokaJapan


Hokkaido University Hospital060-8648 HokkaidoJapan


Kobe University Hospital650-0017 HyogoJapan


Miyagi Cancer Center981-1293 MiyagiJapan


Okayama University Hospital700-8558 OkayamaJapan


Osaka International Cancer Institute541-8567 OsakaJapan


Shizuoka Cancer Center41109340 Shizuoka

Japan


National Cancer Center Hospital104-0045 TokyoJapan


The Jikei University Hospital105-8471 TokyoJapan


Tokyo Medical & Dental University Hospital113-8519 TokyoJapan


The Cancer Institute Hospital of JFCR135-8550 TokyoJapan


Tokyo Medical University Hospital160-0023 TokyoJapan


Seoul National University Bundang Hospital13620 Gyeonggi-doKorea, Republic of


Seoul National University Hospital03080 SeoulKorea, Republic of


Asan Medical Center - Oncology05505 SeoulKorea, Republic of


Samsung Medical Center6351 SeoulKorea, Republic of


Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii80-214 GdańskPoland


Centrum Onkologii-Instytut Im. Marii Skłodowskiej Curie; I Klinika Radioterapii i Chemioterapii44-101 GliwicePoland


COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej20-090 LublinPoland


Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu.60-780 PoznańPoland


Centrum Onkologii-Instytut Im. Marii Skłodowskiej Curie; Klinika Nowotworów Głowy i Szyi02-781 WarszawaPoland


IPO de Coimbra; Servico de Oncologia Medica3000-075 CoimbraPortugal


Hospital de Santa Maria; Servico de Oncologia Medica1649-035 LisboaPortugal


IPO do Porto; Servico de Oncologia Medica4200-072 PortoPortugal


FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF197758 St PetersburgRussian Federation

Status: Abgebrochen

First MSMU n.a. Sechenov Univercity Hospital 1; Plastic surgery119435 MoskvaRussian Federation


FSAI Treatment and rehabilitation Centre Ministry of Health; Clinical research and chemotherapy.125367 MoskvaRussian Federation


Arkhangelsk Regional Clinical Oncology Dispensary163045 ArkhangelskRussian Federation

Status: Abgebrochen

Sverdlovsk Regional Oncology Dispensary; Chemotherapy620905 EkaterinburgRussian Federation


Ivanovo Regional Oncology Dispensary; Chemotherapy Department153013 IvanovoRussian Federation

Status: Abgebrochen

Krasnodar City Oncology Center350040 KrasnodarRussian Federation


Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy660133 KrasnoyarskRussian Federation


Main Military Clinical Hospital named after N.N. Burdenko105229 MoscowRussian Federation


P.A. Herzen Oncological Inst. ; Oncology125284 MoscowRussian Federation


Moscow city oncology hospital #62 of Moscow Healthcare Department

143423 MoscowRussian Federation


City Oncology Hospital; Chemotherapy Dept603000 Nizhny NovgorodRussian Federation


Novosibirsk Regional Oncological Dispancer630108 NovosibirskRussian Federation


BHI of Omsk region Clinical Oncology Dispensary644013 OmskRussian Federation


S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)197758 Saint-PetersburgRussian Federation


Tomsk scientific research institute of oncology SO RAMN, PAD; Pathological634050 TomskRussian Federation


Universitas Annex, University of the Free State; Clinical Oncology9300 BloemfonteinSouth Africa


Groote Schuur Hospital ( Uni of Capetown ); Oncology Dept

7506 Cape TownSouth Africa


Tygerberg Hospital; Oncology Dept7530 Cape TownSouth Africa


Cape Town Oncology Trials7570 Cape TownSouth Africa


GVI Rondebosch Oncology Centre7700 Cape TownSouth Africa


GVI Oncology Outeniqua Unit; GVI Oncology Outeniqua Unit6530 GeorgeSouth Africa


Wits Clinical Research; Charlotte Maxeke Johannesburg Academic Hospital2193 JohannesburgSouth Africa


The Oncology Centre; Haematology - Radiation Oncology4001 MayvilleSouth Africa


Langenhoven Drive Oncology Centre6045 Port Elizabeth

South Africa


Steve Biko Academic Hospital; Oncology0002 PretoriaSouth Africa


Sandton Oncology Medical Group2196 SandtonSouth Africa


Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia08916 BadalonaSpain


Insititut Catala D'Oncologia08908 Hospitalet de LlobregatSpain


Hospital Clínic i Provincial; Servicio de Hematología y Oncología08036 BarcelonaSpain


Hospital General Universitario Gregorio Marañon; Servicio de Oncologia28007 MadridSpain


Hospital Universitario Clínico San Carlos; Servicio de Oncologia28040 MadridSpain


Hospital Universitario 12 de Octubre; Servicio de Oncologia28041 MadridSpain


Hospital Clinico Universitario de Salamanca; Servicio de Oncologia37007 SalamancaSpain


Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia41014 SevillaSpain


Hospital Universitario la Fe; Servicio de Oncologia46026 ValenciaSpain


Hosp Clinico Univ Lozano Blesa50009 ZaragozaSpain


China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H404 TaichungTaiwan


Taichung Veterans General Hospital; Radiation OncologyTaichungTaiwan


National Cheng Kung Unversity Hospital; Oncology00704 TainanTaiwan


Division of Hematology and Oncology, Taipei Veterans General Hospital112 TaipeiTaiwan


National Taiwan University Hospital; OncologyTaipeiTaiwan


Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc10400 BangkokThailand


Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology10700 BangkokThailand


Songklanagarind Hospital; Department of Oncology90110 SongkhlaThailand


Adana Baskent University Hospital; Medical Oncology

01120 AdanaTurkey


Hacettepe Universitesi Tip Fakultesi Hastanesi; Ic Hastaliklari Anabiim Dali06100 AnkaraTurkey


Dr. Abdurrahman Yurtarslan Oncology Hospital; 2nd Oncology Clinic06200 AnkaraTurkey


Gazi University Medical Faculty, Oncology Hospital06500 AnkaraTurkey


Medikal Park Izmir Hospital35575 KarşıyakaTurkey


Municipal Noncommercial Institution Regional Center of Oncology61070 KharkivUkraine


Medical Center "Adonis" LLC08112 Kapitanovka VillageUkraine


Vinnytsya Regional Clinical Oncology Dispensary21029 Vinnytsya

Ukraine


Medical Center ONCOLIFE69059 ZaporizhzhiaUkraine


CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR49102 DnipropetrovskUkraine

Status: Abgebrochen

Ivano-Frankivsk Regional Oncology Center76018 Ivano-FrankivskUkraine


SI Institute of Medical Radiology n.a. S.P. Hryhoriev of NAMS of Ukraine61024 KharkivUkraine


Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients03115 KievUkraine


MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department50048 Kryvyi RihUkraine


Lviv State Oncology Regional Treatment and Diagnostic Centre; Department of

hemotherapy79031 LvivUkraine


RCI Sumy Regional Clinical Oncological Dispensary40005 SumyUkraine


Aberdeen Royal Infirmary; Medical Oncology DeptAB25 2ZN AberdeenUnited Kingdom


Queen Elizabeth HospitalB15 2TH BirminghamUnited Kingdom


Velindre Cancer CentreCF14 2TL CardiffUnited Kingdom


The Royal Marsden Hospital, FulhamSW3 6JJ LondonUnited Kingdom


The Christie NHS Foundation TrustM20 4BX ManchesterUnited Kingdom


Churchill Hospital; Oxford Cancer and Haematology Centre

OX3 7LJ OxfordUnited Kingdom


Derriford HospitalPL6 8DH PlymouthUnited Kingdom


Royal Marsden NHS Foundation TrustSM2 5PT SuttonUnited Kingdom


Quelle: ClinicalTrials.gov

a study of atezolizumab (anti−pd-l1 antibody) as adjuvant ... filea study of atezolizumab...

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