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JOURNAL ONKOLOGIE – STUDIE

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 Neck

Rekrutierend

NCT-Nummer:
NCT03452137

Studienbeginn:
April 2018

Letztes Update:
01.04.2021

Wirkstoff:
Atezolizumab, Placebo

Indikation (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:
-

Studienleiter

Clinical Trials
Study Director
Hoffmann-La Roche

Kontakt

Reference Study ID Number: WO40242 www.roche.com/about_roche/roche_worldwide.htm
Kontakt:
Phone: 888-662-6728 (U.S. and Canada)
E-Mail: global-roche-genentech-trials@gene.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 189)

Charité - Campus Benjamin Franklin; Innere Medizin, Haematologie/Onkologie
12203 Berlin
(Berlin)
GermanyZurückgezogen» Google-Maps
Universitätsklinikum Bonn; Med. Klinik und Poliklinik III; Hämatologie, Onkologie und Rheumatologie
53127 Bonn
(Nordrhein-Westfalen)
GermanyAbgeschlossen» Google-Maps
Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
79106 Freiburg
(Baden-Württemberg)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsklinikum Schleswig-Holstein; Klinik F. Strahlentherapie
24105 Kiel
(Schleswig-Holstein)
GermanyZurückgezogen» Google-Maps
Klinikum d. Uni. München; Campus Großhadern; Klinik und Poliklinik f. Strahlenthera. und Radioonko
81377 München
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsmedizin Rostock, Klinik und Poliklinik für Strahlentherapie; Zentrum für Radiologie
18059 Rostock
(Mecklenburg-Vorpommern)
GermanyAktiv, nicht rekrutierend» Google-Maps
Southern Cancer Center
36526 Daphne
United StatesZurückgezogen» Google-Maps
University of Arizona
85724-5030 Tucson
United StatesZurückgezogen» Google-Maps
Kaiser Permanente - Bellflower
90706 Bellflower
United StatesZurückgezogen» Google-Maps
City of Hope National Medical Center
91010 Duarte
United StatesAktiv, nicht rekrutierend» Google-Maps
University of California San Diego Medical Center; Moores Cancer Center
92093 La Jolla
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Oklahoma
90033 Los Angeles
United StatesZurückgezogen» Google-Maps
UCLA Hematology/Oncology
90404 Santa Monica
United StatesAktiv, nicht rekrutierend» Google-Maps
Kaiser Permanente - Vallejo
94589 Vallejo
United StatesZurückgezogen» Google-Maps
Rocky Mountain Regional VA Medical Center
80045 Aurora
United StatesZurückgezogen» Google-Maps
Georgetown U; Lombardi Comp Can
20016-1468 Washington
United StatesZurückgezogen» Google-Maps
Johns Hopkins Sidney Kimmel Cancer Center at Sibley Memorial Hospital
20016 Washington
United StatesZurückgezogen» Google-Maps
Miami Cancer Institute of Baptist Health, Inc.
33176 Miami
United StatesAktiv, nicht rekrutierend» Google-Maps
Woodlands Medical Specialists, P.A.
32503 Pensacola
United StatesAbgeschlossen» Google-Maps
Winship Cancer Institute of Emory University
30329 Atlanta
United StatesAbgeschlossen» Google-Maps
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
30060 Marietta
United StatesAktiv, nicht rekrutierend» Google-Maps
Northwestern Medical Group/Northwestern University
60611 Chicago
United StatesZurückgezogen» Google-Maps
Cancer Center of Kansas
67214-3728 Wichita
United StatesAktiv, nicht rekrutierend» Google-Maps
Maryland Oncology Hematology Columbia - USOR
21044 Columbia
United StatesZurückgezogen» Google-Maps
Dana-Farber Cancer Institute
02215 Boston
United StatesAktiv, nicht rekrutierend» Google-Maps
Henry Ford Health System
48202 Detroit
United StatesZurückgezogen» Google-Maps
Billings Clinic Research Center
59101 Billings
United StatesAktiv, nicht rekrutierend» Google-Maps
Morristown Medical Center
07962 Morristown
United StatesZurückgezogen» Google-Maps
New York Oncology Hematology,P.C.-Albany
12208 Albany
United StatesZurückgezogen» Google-Maps
Cleveland Clinic; Taussig Cancer Institute
44195 Cleveland
United StatesAktiv, nicht rekrutierend» Google-Maps
OSU, James Cancer Hospital
43210 Columbus
United StatesZurückgezogen» Google-Maps
Fox Chase Cancer Center; Hematology/Oncology
19111 Philadelphia
United StatesZurückgezogen» Google-Maps
Blue Ridge Cancer Care
24014 Roanoke
United StatesAktiv, nicht rekrutierend» Google-Maps
Northwest Cancer Specialists - Vancouver
98684 Vancouver
United StatesZurückgezogen» Google-Maps
St George Hospital
2217 Kogarah
AustraliaAktiv, nicht rekrutierend» Google-Maps
Adelaide Cancer Centre
5037 Kurralta Park
AustraliaAktiv, nicht rekrutierend» Google-Maps
Peter MacCallum Cancer Center
3002 East Melbourne
AustraliaAktiv, nicht rekrutierend» Google-Maps
Sir Charles Gairdner Hospital
6009 Nedlands
AustraliaAktiv, nicht rekrutierend» Google-Maps
Clinique Ste-Elisabeth
5000 Namur
BelgiumAktiv, nicht rekrutierend» Google-Maps
Santa Casa de Misericordia de Salvador
40050-410 Salvador
BrazilAktiv, nicht rekrutierend» Google-Maps
Hospital do Cancer de Pernambuco - HCP
50040-000 Recife
BrazilAktiv, nicht rekrutierend» Google-Maps
Instituto Nacional de Cancer - INCa; Oncologia
20560-120 Rio de Janeiro
BrazilAktiv, nicht rekrutierend» Google-Maps
Hospital Sao Lucas - PUCRS
90610-000 Porto Alegre
BrazilAktiv, nicht rekrutierend» Google-Maps
Hospital Nossa Senhora da Conceicao
91350-200 Porto Alegre
BrazilAktiv, nicht rekrutierend» Google-Maps
Faculdade de Medicina do ABC - FMABC
09060-650 Santo Andre
BrazilAktiv, nicht rekrutierend» Google-Maps
Instituto do Cancer do Estado de Sao Paulo - ICESP
01246-000 Sao Paulo
BrazilAktiv, nicht rekrutierend» Google-Maps
Cross Cancer Institute
T6G 1Z2 Edmonton
CanadaAktiv, nicht rekrutierend» Google-Maps
Fraser Valley Centre British Columbia Cancer Agency
V3V 1Z2 Surrey
CanadaZurückgezogen» Google-Maps
London Health Sciences Centre
N6A 4L6 London
CanadaAktiv, nicht rekrutierend» Google-Maps
Xiangya Hospital of Centre-South University
410008 Changsha
ChinaZurückgezogen» Google-Maps
West China Hospital, Sichuan University
610041 Chengdu
ChinaRekrutierend» Google-Maps
The Second Affiliated Hospital of Zhejiang University School of Medicine
310009 Hangzhou City
ChinaRekrutierend» Google-Maps
Harbin Medical University Cancer Hospital
150081 Harbin
ChinaNoch nicht rekrutierend» Google-Maps
Jiangxi Cancer Hospital; First department of abdominal surgery
330029 Nanchang
ChinaZurückgezogen» Google-Maps
Fudan University Shanghai Cancer Center
200120 Shanghai City
ChinaRekrutierend» Google-Maps
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
200011 Shanghai
ChinaRekrutierend» Google-Maps
Tianjin Medical University General Hospital
300052 Tianjin
ChinaRekrutierend» Google-Maps
Union Hospital Tongji Medical College Huazhong University of Science and Technology
430023 Wuhan City
ChinaRekrutierend» Google-Maps
Institut Sainte Catherine
84918 Avignon
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Georges Francois Leclerc
21000 Dijon
FranceAktiv, nicht rekrutierend» Google-Maps
CENTRE LEON BERARD; Département d'Hématologie et d'Oncologie
69373 Lyon
FranceAktiv, nicht rekrutierend» Google-Maps
Hopital Timone Adultes; Oncologie Medicale Et Usp
13385 Marseille
FranceAktiv, nicht rekrutierend» Google-Maps
ICM; Radiotherapie
34298 Montpellier Cedex 5
FranceAktiv, nicht rekrutierend» Google-Maps
Hopital Tenon; Oncologie Radiotherapie
75970 Paris
FranceAktiv, nicht rekrutierend» Google-Maps
Hôpitaux D'Instruction Des Armees Begin
94160 St Mande
FranceAktiv, nicht rekrutierend» Google-Maps
Gustave Roussy Cancer Campus; Radiotherapie
94805 VILLEJUIF Cedex
FranceAktiv, nicht rekrutierend» Google-Maps
Orszagos Onkologial Intezet; Onkologiai Osztaly X
1122 Budapest
HungaryAktiv, nicht rekrutierend» Google-Maps
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
7623 Pécs
HungaryAktiv, nicht rekrutierend» Google-Maps
Rajiv Gandhi Cancer Institute & Research Center
110085 New Delhi
IndiaZurückgezogen» Google-Maps
Medanta-The Medicity
122001 Gurgaon
IndiaAktiv, nicht rekrutierend» Google-Maps
Tata Memorial Hospital; Dept of Medical Oncology
400012 Mumbai
IndiaAktiv, nicht rekrutierend» Google-Maps
TATA Medical Centre; Medical Oncology
700156 Kolkata
IndiaZurückgezogen» Google-Maps
Max Super Speciality Hospital
110017 New Delhi
IndiaZurückgezogen» Google-Maps
Istituto Nazionale Tumori Fondazione G. Pascale; S.C. Oncol. Medica Testa-Collo e Sarcoma
80131 Napoli
ItalyAbgeschlossen» Google-Maps
Ospedale Umberto I ASL di Ravenna Presidio Ospedaliero di Lugo
Lugo
ItalyAktiv, nicht rekrutierend» Google-Maps
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
47014 Meldola
ItalyAktiv, nicht rekrutierend» Google-Maps
Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
00161 Roma
ItalyAktiv, nicht rekrutierend» Google-Maps
Ospedale Civile; Servizio Oncologia
17100 Savona
ItalyAktiv, nicht rekrutierend» Google-Maps
Spedali Civili di Brescia
25123 Brescia
ItalyAktiv, nicht rekrutierend» Google-Maps
Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo
20133 Milano
ItalyAktiv, nicht rekrutierend» Google-Maps
Asst Santi Paolo E Carlo; Unita Operativa Di Oncologia Medica
20142 Milano
ItalyAktiv, nicht rekrutierend» Google-Maps
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
20089 Rozzano
ItalyAktiv, nicht rekrutierend» Google-Maps
Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
50134 Firenze
ItalyAktiv, nicht rekrutierend» Google-Maps
IOV - Istituto Oncologico Veneto IRCCS
35128 Padova
ItalyAktiv, nicht rekrutierend» Google-Maps
Aichi Cancer Center Hospital
464-8681 Aichi
JapanAktiv, nicht rekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Chiba
JapanAktiv, nicht rekrutierend» Google-Maps
National Hospital Organization Kyushu Cancer Center
811-1395 Fukuoka
JapanAktiv, nicht rekrutierend» Google-Maps
Hokkaido University Hospital
060-8648 Hokkaido
JapanAktiv, nicht rekrutierend» Google-Maps
Kobe University Hospital
650-0017 Hyogo
JapanAktiv, nicht rekrutierend» Google-Maps
Miyagi Cancer Center
981-1293 Miyagi
JapanAktiv, nicht rekrutierend» Google-Maps
Okayama University Hospital
700-8558 Okayama
JapanAktiv, nicht rekrutierend» Google-Maps
Osaka International Cancer Institute
541-8567 Osaka
JapanAktiv, nicht rekrutierend» Google-Maps
Shizuoka Cancer Center
411-8777 Shizuoka
JapanAktiv, nicht rekrutierend» Google-Maps
National Cancer Center Hospital
104-0045 Tokyo
JapanAktiv, nicht rekrutierend» Google-Maps
The Jikei University Hospital
105-8471 Tokyo
JapanAktiv, nicht rekrutierend» Google-Maps
Tokyo Medical And Dental University, Medical Hospital
113-8519 Tokyo
JapanAktiv, nicht rekrutierend» Google-Maps
The Cancer Institute Hospital of JFCR
135-8550 Tokyo
JapanAktiv, nicht rekrutierend» Google-Maps
Tokyo Medical University Hospital
160-0023 Tokyo
JapanAktiv, nicht rekrutierend» Google-Maps
Seoul National University Bundang Hospital
13605 Seongnam-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Samsung Medical Center
(0)6351 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
80-214 Gdańsk
PolandAktiv, nicht rekrutierend» Google-Maps
Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.
44-101 Gliwice
PolandAbgeschlossen» Google-Maps
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
20-090 Lublin
PolandZurückgezogen» Google-Maps
Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu.
60-780 Poznań
PolandZurückgezogen» Google-Maps
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowotworów Głowy i Szyi
02-781 Warszawa
PolandAktiv, nicht rekrutierend» Google-Maps
IPO de Coimbra; Servico de Oncologia Medica
3000-075 Coimbra
PortugalAktiv, nicht rekrutierend» Google-Maps
Hospital de Santa Maria; Servico de Oncologia Medica
1649-035 Lisboa
PortugalAktiv, nicht rekrutierend» Google-Maps
IPO do Porto; Servico de Oncologia Medica
4200-072 Porto
PortugalAktiv, nicht rekrutierend» Google-Maps
FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF
197758 St Petersburg
Russian FederationZurückgezogen» Google-Maps
First MSMU n.a. Sechenov Univercity Hospital 1; Plastic surgery
119435 Moskva
Russian FederationAktiv, nicht rekrutierend» Google-Maps
FSAI Treatment and rehabilitation Centre Ministry of Health; Clinical research and chemotherapy.
125367 Moskva
Russian FederationAbgeschlossen» Google-Maps
Arkhangelsk Regional Clinical Oncology Dispensary
163045 Arkhangelsk
Russian FederationZurückgezogen» Google-Maps
Sverdlovsk Regional Oncology Dispensary; Chemotherapy
620905 Ekaterinburg
Russian FederationAbgeschlossen» Google-Maps
Ivanovo Regional Oncology Dispensary; Chemotherapy Department
153013 Ivanovo
Russian FederationZurückgezogen» Google-Maps
Krasnodar City Oncology Center
350040 Krasnodar
Russian FederationZurückgezogen» Google-Maps
Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy
660133 Krasnoyarsk
Russian FederationAbgeschlossen» Google-Maps
Main Military Clinical Hospital named after N.N. Burdenko
105229 Moscow
Russian FederationAktiv, nicht rekrutierend» Google-Maps
P.A. Herzen Oncological Inst. ; Oncology
125284 Moscow
Russian FederationAktiv, nicht rekrutierend» Google-Maps
Moscow city oncology hospital #62 of Moscow Healthcare Department
143423 Moscow
Russian FederationAktiv, nicht rekrutierend» Google-Maps
City Oncology Hospital; Chemotherapy Dept
603000 Nizhny Novgorod
Russian FederationZurückgezogen» Google-Maps
Novosibirsk Regional Oncological Dispancer
630108 Novosibirsk
Russian FederationAktiv, nicht rekrutierend» Google-Maps
BHI of Omsk region Clinical Oncology Dispensary
644013 Omsk
Russian FederationAktiv, nicht rekrutierend» Google-Maps
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
197758 Saint-Petersburg
Russian FederationAktiv, nicht rekrutierend» Google-Maps
Tomsk scientific research institute of oncology SO RAMN, PAD; Pathological
634050 Tomsk
Russian FederationAktiv, nicht rekrutierend» Google-Maps
Universitas Annex, University of the Free State; Clinical Oncology
9300 Bloemfontein
South AfricaZurückgezogen» Google-Maps
Groote Schuur Hospital ( Uni of Capetown ); Oncology Dept
7506 Cape Town
South AfricaZurückgezogen» Google-Maps
Tygerberg Hospital; Oncology Dept
7530 Cape Town
South AfricaAktiv, nicht rekrutierend» Google-Maps
Cape Town Oncology Trials
7570 Cape Town
South AfricaZurückgezogen» Google-Maps
Cancercare Rondebosch Oncology
7700 Cape Town
South AfricaZurückgezogen» Google-Maps
GVI Oncology Outeniqua Unit; GVI Oncology Outeniqua Unit
6530 George
South AfricaAktiv, nicht rekrutierend» Google-Maps
Wits Clinical Research; Charlotte Maxeke Johannesburg Academic Hospital
2193 Johannesburg
South AfricaZurückgezogen» Google-Maps
The Oncology Centre; Haematology - Radiation Oncology
4001 Mayville
South AfricaAktiv, nicht rekrutierend» Google-Maps
Langenhoven Drive Oncology Centre
6045 Port Elizabeth
South AfricaZurückgezogen» Google-Maps
Steve Biko Academic Hospital; Oncology
0002 Pretoria
South AfricaAktiv, nicht rekrutierend» Google-Maps
Sandton Oncology Medical Group
2196 Sandton
South AfricaZurückgezogen» Google-Maps
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
08916 Badalona
SpainAktiv, nicht rekrutierend» Google-Maps
Insititut Catala D'Oncologia
08908 Hospitalet de Llobregat
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
08036 Barcelona
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
28007 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
28040 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario 12 de Octubre; Servicio de Oncologia
28041 Madrid
SpainAbgeschlossen» Google-Maps
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
37007 Salamanca
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
41014 Sevilla
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario la Fe; Servicio de Oncologia
46026 Valencia
SpainAktiv, nicht rekrutierend» Google-Maps
Hosp Clinico Univ Lozano Blesa
50009 Zaragoza
SpainAktiv, nicht rekrutierend» Google-Maps
China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H
404 Taichung
TaiwanAktiv, nicht rekrutierend» Google-Maps
Taichung Veterans General Hospital; Radiation Oncology
Taichung
TaiwanAktiv, nicht rekrutierend» Google-Maps
National Cheng Kung University Hospital; Oncology
00704 Tainan
TaiwanAktiv, nicht rekrutierend» Google-Maps
Division of Hematology and Oncology, Taipei Veterans General Hospital
112 Taipei
TaiwanAktiv, nicht rekrutierend» Google-Maps
National Taiwan University Hospital; Oncology
10048 Zhongzheng Dist.
TaiwanAktiv, nicht rekrutierend» Google-Maps
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
10400 Bangkok
ThailandAktiv, nicht rekrutierend» Google-Maps
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
10700 Bangkok
ThailandAktiv, nicht rekrutierend» Google-Maps
Songklanagarind Hospital; Department of Oncology
90110 Songkhla
ThailandAktiv, nicht rekrutierend» Google-Maps
Adana Baskent University Hospital; Medical Oncology
01120 Adana
TurkeyZurückgezogen» Google-Maps
Hacettepe Universitesi Tip Fakultesi Hastanesi; Ic Hastaliklari Anabiim Dali
06100 Ankara
TurkeyAktiv, nicht rekrutierend» Google-Maps
Dr. Abdurrahman Yurtarslan Oncology Hospital; 2nd Oncology Clinic
06200 Ankara
TurkeyAktiv, nicht rekrutierend» Google-Maps
Gazi University Medical Faculty, Oncology Hospital
06500 Ankara
TurkeyAktiv, nicht rekrutierend» Google-Maps
Medikal Park Izmir Hospital
35575 Karşıyaka
TurkeyAktiv, nicht rekrutierend» Google-Maps
Municipal Noncommercial Institution Regional Center of Oncology
61070 Kharkiv
UkraineAktiv, nicht rekrutierend» Google-Maps
Medical Center "Adonis" LLC
08112 Kapitanovka Village
UkraineZurückgezogen» Google-Maps
Vinnytsya Regional Clinical Oncology Dispensary
21029 Vinnytsya
UkraineAktiv, nicht rekrutierend» Google-Maps
Medical Center ONCOLIFE
69059 Zaporizhzhia
UkraineZurückgezogen» Google-Maps
CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR
49102 Dnipropetrovsk
UkraineZurückgezogen» Google-Maps
Ivano-Frankivsk Regional Oncology Center
76018 Ivano-Frankivsk
UkraineAktiv, nicht rekrutierend» Google-Maps
SI Institute of Medical Radiology n.a. S.P. Hryhoriev of NAMS of Ukraine
61024 Kharkiv
UkraineZurückgezogen» Google-Maps
Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients
03115 Kiev
UkraineAktiv, nicht rekrutierend» Google-Maps
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department
50048 Kryvyi Rih
UkraineAktiv, nicht rekrutierend» Google-Maps
Lviv State Oncology Regional Treatment and Diagnostic Centre; Department of hemotherapy
79031 Lviv
UkraineAktiv, nicht rekrutierend» Google-Maps
RCI Sumy Regional Clinical Oncological Dispensary
40005 Sumy
UkraineAbgeschlossen» Google-Maps
Aberdeen Royal Infirmary; Medical Oncology Dept
AB25 2ZN Aberdeen
United KingdomAktiv, nicht rekrutierend» Google-Maps
Queen Elizabeth Hospital
B15 2TH Birmingham
United KingdomZurückgezogen» Google-Maps
Velindre Cancer Centre
CF14 2TL Cardiff
United KingdomAktiv, nicht rekrutierend» Google-Maps
The Royal Marsden Hospital, Fulham
SW3 6JJ London
United KingdomAktiv, nicht rekrutierend» Google-Maps
The Christie NHS Foundation Trust
M20 4BX Manchester
United KingdomZurückgezogen» Google-Maps
Churchill Hospital; Oxford Cancer and Haematology Centre
OX3 7LJ Oxford
United KingdomZurückgezogen» Google-Maps
Derriford Hospital
PL6 8DH Plymouth
United KingdomAktiv, nicht rekrutierend» Google-Maps
Royal Marsden NHS Foundation Trust
SM2 5PT Sutton
United KingdomAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief 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

squamous cell carcinoma of the head and neck (SCCHN)

Ein-/Ausschlusskriterien

Inclusion 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-Rationale

Primary outcome:

1. Investigator-assessed Event Free Survival (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 54 months))

2. Overall Survival (OS) after Randomization (Time Frame - Randomization to death from any cause, through the end of study (approximately 54 months))

Secondary 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 RECIST v1.1) or death from any cause, whichever occurs first, through the end of study (approximately 54 months))

2. Percentage of Participants with Adverse Events (Time Frame - Baseline until up to 90 days after end of treatment (approximately 54 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 54 months overall))

Studien-Arme

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

Quelle: ClinicalTrials.gov


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