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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

Primary Purpose

Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atezolizumab
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope National Medical Center
  • University of California San Diego Medical Center; Moores Cancer Center
  • UCLA Hematology/Oncology
  • Miami Cancer Institute of Baptist Health, Inc.
  • Woodlands Medical Specialists, P.A.
  • Winship Cancer Institute of Emory University
  • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
  • Cancer Center of Kansas
  • Dana-Farber Cancer Institute
  • Billings Clinic Research Center
  • Cleveland Clinic; Taussig Cancer Institute
  • Blue Ridge Cancer Care
  • St George Hospital
  • Adelaide Cancer Centre
  • Peter MacCallum Cancer Center
  • Sir Charles Gairdner Hospital
  • Clinique Ste-Elisabeth
  • Santa Casa de Misericordia de Salvador
  • Hospital do Cancer de Pernambuco - HCP
  • Instituto Nacional de Cancer - INCa; Oncologia
  • Hospital Sao Lucas - PUCRS
  • Hospital Nossa Senhora da Conceicao
  • Faculdade de Medicina do ABC - FMABC
  • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • Cross Cancer Institute
  • Cancer Care Manitoba
  • London Health Sciences Centre
  • Beijing Cancer Hospital
  • West China Hospital, Sichuan University
  • Fujian Cancer Hospital
  • Fudan University Shanghai Cancer Center
  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Shanghai East Hospital
  • Tianjin Medical University General Hospital
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Zhejiang Cancer Hospital
  • Institut Sainte Catherine
  • Centre Georges Francois Leclerc
  • CENTRE LEON BERARD; Département d?Hématologie et d?Oncologie
  • Hopital Timone Adultes; Oncologie Medicale Et Usp
  • ICM; Radiotherapie
  • Hopital Tenon; Oncologie Radiotherapie
  • CHU Bordeaux
  • Hôpitaux D'Instruction Des Armees Begin
  • Gustave Roussy Cancer Campus; Radiotherapie
  • Universitätsklinikum Bonn; Med. Klinik und Poliklinik III; Hämatologie, Onkologie und Rheumatologie
  • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
  • Klinikum d. Uni. München; Campus Großhadern; Klinik und Poliklinik f. Strahlenthera. und Radioonko
  • Universitätsmedizin Rostock, Klinik und Poliklinik für Strahlentherapie; Zentrum für Radiologie
  • Orszagos Onkologial Intezet; Onkologiai Osztaly X
  • Budapesti Uzsoki Utcai Kórház
  • Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
  • Medanta-The Medicity
  • Tata Memorial Hospital; Dept of Medical Oncology
  • Istituto Nazionale Tumori Fondazione G. Pascale; S.C. Oncol. Medica Testa-Collo e Sarcoma
  • Ospedale Umberto I ASL di Ravenna Presidio Ospedaliero di Lugo
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
  • Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
  • Ospedale Civile; Servizio Oncologia
  • Spedali Civili di Brescia
  • Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo
  • Asst Santi Paolo E Carlo; Unita Operativa Di Oncologia Medica
  • Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
  • Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
  • IOV - Istituto Oncologico Veneto IRCCS
  • Aichi Cancer Center Hospital
  • National Cancer Center Hospital East
  • National Hospital Organization Kyushu Cancer Center
  • Hokkaido University Hospital
  • Kobe University Hospital
  • Miyagi Cancer Center
  • Okayama University Hospital
  • Osaka International Cancer Institute
  • Shizuoka Cancer Center
  • National Cancer Center Hospital
  • The Jikei University Hospital
  • Tokyo Medical and Dental University Hospital
  • The Cancer Institute Hospital of JFCR
  • Tokyo Medical University Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
  • Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.
  • Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowotworów G?owy i Szyi
  • IPO de Coimbra; Servico de Oncologia Medica
  • Hospital de Santa Maria; Servico de Oncologia Medica
  • IPO do Porto; Servico de Oncologia Medica
  • Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy
  • Moscow City Oncology Hospital #62
  • Main Military Clinical Hospital named after N.N. Burdenko
  • P.A. Herzen Oncological Inst. ; Oncology
  • First MSMU n.a. Sechenov Univercity Hospital 1; Plastic surgery
  • FSAI Treatment and rehabilitation Centre Ministry of Health; Clinical research and chemotherapy.
  • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
  • Sverdlovsk Regional Oncology Dispensary; Chemotherapy
  • Novosibirsk Regional Oncological Dispancer
  • BHI of Omsk region Clinical Oncology Dispensary
  • Tomsk scientific research institute of oncology SO RAMN, PAD; Pathological
  • Tygerberg Hospital; Oncology Dept
  • GVI Oncology Outeniqua Unit
  • The Oncology Centre; Haematology - Radiation Oncology
  • Steve Biko Academic Hospital; Oncology
  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
  • Insititut Catala D'Oncologia
  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
  • Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
  • Hospital Universitario la Fe; Servicio de Oncologia
  • China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H
  • Taichung Veterans General Hospital; Radiation Oncology
  • National Cheng Kung University Hospital; Oncology
  • Division of Hematology and Oncology, Taipei Veterans General Hospital
  • National Taiwan University Hospital; Oncology
  • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
  • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
  • Songklanagarind Hospital; Department of Oncology
  • Hacettepe Universitesi Tip Fakultesi Hastanesi
  • Dr. Abdurrahman Yurtarslan Oncology Hospital; 2nd Oncology Clinic
  • Gazi University Medical Faculty, Oncology Hospital
  • ?zmir Medical Point; Oncology
  • Municipal Noncommercial Institution Regional Center of Oncology
  • Vinnytsya Regional Clinical Oncology Dispensary
  • Ivano-Frankivsk Regional Oncology Center
  • Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients
  • ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department
  • Lviv State Oncology Regional Treatment and Diagnostic Centre; Department of hemotherapy
  • RCI Sumy Regional Clinical Oncological Dispensary
  • Aberdeen Royal Infirmary; Medical Oncology Dept
  • Velindre Cancer Centre
  • The Royal Marsden Hospital, Fulham
  • Derriford Hospital
  • Royal Marsden NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Atezolizumab

Placebo

Arm Description

Participants will receive Atezolizumab for 16 cycles, or up to 1 year (whichever occurs first)

Participants will receive Placebo for 16 cycles, or up to 1 year (whichever occurs first).

Outcomes

Primary Outcome Measures

Investigator-assessed Event Free Survival (EFS)

Secondary Outcome Measures

Overall Survival (OS) after Randomization
Independent Review Facility-assessed Event Free Survival (IRF-assessed EFS)
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
Percentage of Participants with Adverse Events
Serum Concentration of Atezolizumab
Incidence of ADA Response to Atezolizumab

Full Information

First Posted
February 25, 2018
Last Updated
September 14, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03452137
Brief Title
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
Official Title
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 3, 2018 (Actual)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
June 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
406 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atezolizumab
Arm Type
Active Comparator
Arm Description
Participants will receive Atezolizumab for 16 cycles, or up to 1 year (whichever occurs first)
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Participants will receive Placebo for 16 cycles, or up to 1 year (whichever occurs first).
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Intervention Description
Atezolizumab intravenous infusion will be administered at a fixed dose on Day 1 of each 21-day cycle for 16 cycles.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo intravenous infusion will be administered a fixed dose on Day 1 of each 21-day cycle for 16 cycles.
Primary Outcome Measure Information:
Title
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 65 months)
Secondary Outcome Measure Information:
Title
Overall Survival (OS) after Randomization
Time Frame
Randomization to death from any cause, through the end of study (approximately 99 months)
Title
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 65 months)
Title
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 to 3 Months and 6 Months
Title
Percentage of Participants with Adverse Events
Time Frame
Baseline until up to 90 days after end of treatment (approximately 99 months)
Title
Serum Concentration of Atezolizumab
Time Frame
At pre-defined intervals from Cycle 1, Day 1, through end of treatment (approximately 1 year).
Title
Incidence of ADA Response to Atezolizumab
Time Frame
At pre-defined intervals from Cycle 1, Day 1, through end of treatment (approximately 1 year).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California San Diego Medical Center; Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UCLA Hematology/Oncology
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Miami Cancer Institute of Baptist Health, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Woodlands Medical Specialists, P.A.
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3728
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Billings Clinic Research Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Cleveland Clinic; Taussig Cancer Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Blue Ridge Cancer Care
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
St George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Adelaide Cancer Centre
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
Peter MacCallum Cancer Center
City
North Melbourne
State/Province
Victoria
ZIP/Postal Code
3051
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Clinique Ste-Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Santa Casa de Misericordia de Salvador
City
Salvador
State/Province
BA
ZIP/Postal Code
40050-410
Country
Brazil
Facility Name
Hospital do Cancer de Pernambuco - HCP
City
Recife
State/Province
PE
ZIP/Postal Code
50040-000
Country
Brazil
Facility Name
Instituto Nacional de Cancer - INCa; Oncologia
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20560-120
Country
Brazil
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Faculdade de Medicina do ABC - FMABC
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Cancer Care Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Fujian Cancer Hospital
City
Fuzhou
ZIP/Postal Code
350014
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai City
ZIP/Postal Code
200120
Country
China
Facility Name
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200011
Country
China
Facility Name
Shanghai East Hospital
City
Shanghai
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan City
ZIP/Postal Code
430023
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84082
Country
France
Facility Name
Centre Georges Francois Leclerc
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CENTRE LEON BERARD; Département d?Hématologie et d?Oncologie
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hopital Timone Adultes; Oncologie Medicale Et Usp
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
ICM; Radiotherapie
City
Montpellier Cedex 5
ZIP/Postal Code
34298
Country
France
Facility Name
Hopital Tenon; Oncologie Radiotherapie
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
CHU Bordeaux
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Hôpitaux D'Instruction Des Armees Begin
City
St Mande
ZIP/Postal Code
94160
Country
France
Facility Name
Gustave Roussy Cancer Campus; Radiotherapie
City
VILLEJUIF Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Universitätsklinikum Bonn; Med. Klinik und Poliklinik III; Hämatologie, Onkologie und Rheumatologie
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Klinikum d. Uni. München; Campus Großhadern; Klinik und Poliklinik f. Strahlenthera. und Radioonko
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Universitätsmedizin Rostock, Klinik und Poliklinik für Strahlentherapie; Zentrum für Radiologie
City
Rostock
ZIP/Postal Code
18059
Country
Germany
Facility Name
Orszagos Onkologial Intezet; Onkologiai Osztaly X
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Budapesti Uzsoki Utcai Kórház
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Medanta-The Medicity
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122001
Country
India
Facility Name
Tata Memorial Hospital; Dept of Medical Oncology
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Istituto Nazionale Tumori Fondazione G. Pascale; S.C. Oncol. Medica Testa-Collo e Sarcoma
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale Umberto I ASL di Ravenna Presidio Ospedaliero di Lugo
City
Lugo
State/Province
Emilia-Romagna
ZIP/Postal Code
48022
Country
Italy
Facility Name
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
Ospedale Civile; Servizio Oncologia
City
Savona
State/Province
Liguria
ZIP/Postal Code
17100
Country
Italy
Facility Name
Spedali Civili di Brescia
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Asst Santi Paolo E Carlo; Unita Operativa Di Oncologia Medica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20142
Country
Italy
Facility Name
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
IOV - Istituto Oncologico Veneto IRCCS
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Aichi Cancer Center Hospital
City
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Hokkaido University Hospital
City
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Kobe University Hospital
City
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Miyagi Cancer Center
City
Miyagi
ZIP/Postal Code
981-1293
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
National Cancer Center Hospital
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
The Jikei University Hospital
City
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
Tokyo Medical and Dental University Hospital
City
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
City
Gda?sk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowotworów G?owy i Szyi
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
IPO de Coimbra; Servico de Oncologia Medica
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Hospital de Santa Maria; Servico de Oncologia Medica
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
IPO do Porto; Servico de Oncologia Medica
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy
City
Krasnoyarsk
State/Province
Krasnodar
ZIP/Postal Code
660133
Country
Russian Federation
Facility Name
Moscow City Oncology Hospital #62
City
Moscovskaya Oblast
State/Province
Moskovskaja Oblast
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Main Military Clinical Hospital named after N.N. Burdenko
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
P.A. Herzen Oncological Inst. ; Oncology
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
125248
Country
Russian Federation
Facility Name
First MSMU n.a. Sechenov Univercity Hospital 1; Plastic surgery
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
119435
Country
Russian Federation
Facility Name
FSAI Treatment and rehabilitation Centre Ministry of Health; Clinical research and chemotherapy.
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
City
Saint-Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Sverdlovsk Regional Oncology Dispensary; Chemotherapy
City
Ekaterinburg
State/Province
Sverdlovsk
ZIP/Postal Code
620905
Country
Russian Federation
Facility Name
Novosibirsk Regional Oncological Dispancer
City
Novosibirsk
ZIP/Postal Code
630108
Country
Russian Federation
Facility Name
BHI of Omsk region Clinical Oncology Dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Tomsk scientific research institute of oncology SO RAMN, PAD; Pathological
City
Tomsk
ZIP/Postal Code
634028
Country
Russian Federation
Facility Name
Tygerberg Hospital; Oncology Dept
City
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
GVI Oncology Outeniqua Unit
City
George
ZIP/Postal Code
6530
Country
South Africa
Facility Name
The Oncology Centre; Haematology - Radiation Oncology
City
Mayville
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Steve Biko Academic Hospital; Oncology
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Insititut Catala D'Oncologia
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital Universitario la Fe; Servicio de Oncologia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Taichung Veterans General Hospital; Radiation Oncology
City
Taichung
Country
Taiwan
Facility Name
National Cheng Kung University Hospital; Oncology
City
Tainan
ZIP/Postal Code
00704
Country
Taiwan
Facility Name
Division of Hematology and Oncology, Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
National Taiwan University Hospital; Oncology
City
Zhongzheng Dist.
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Songklanagarind Hospital; Department of Oncology
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Hacettepe Universitesi Tip Fakultesi Hastanesi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Dr. Abdurrahman Yurtarslan Oncology Hospital; 2nd Oncology Clinic
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Facility Name
Gazi University Medical Faculty, Oncology Hospital
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
?zmir Medical Point; Oncology
City
Kar?iyaka
ZIP/Postal Code
35575
Country
Turkey
Facility Name
Municipal Noncommercial Institution Regional Center of Oncology
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Vinnytsya Regional Clinical Oncology Dispensary
City
Vinnytsya
State/Province
Podolia Governorate
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Ivano-Frankivsk Regional Oncology Center
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients
City
Kiev
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department
City
Kryvyi Rih
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
Lviv State Oncology Regional Treatment and Diagnostic Centre; Department of hemotherapy
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
RCI Sumy Regional Clinical Oncological Dispensary
City
Sumy
ZIP/Postal Code
40005
Country
Ukraine
Facility Name
Aberdeen Royal Infirmary; Medical Oncology Dept
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Velindre Cancer Centre
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
The Royal Marsden Hospital, Fulham
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8BT
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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