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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03452137




Registration number
NCT03452137
Ethics application status
Date submitted
25/02/2018
Date registered
2/03/2018
Date last updated
24/04/2024

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
2017-003302-40
Secondary ID [2] 0 0
WO40242
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Placebo

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).


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

Treatment: Drugs: Placebo
Placebo intravenous infusion will be administered a fixed dose on Day 1 of each 21-day cycle for 16 cycles.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Investigator-assessed Event Free Survival (EFS)
Timepoint [1] 0 0
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 [1] 0 0
Overall Survival (OS) after Randomization
Timepoint [1] 0 0
Randomization to death from any cause, through the end of study (approximately 99 months)
Secondary outcome [2] 0 0
Independent Review Facility-assessed Event Free Survival (IRF-assessed EFS)
Timepoint [2] 0 0
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)
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Baseline to 3 Months and 6 Months
Secondary outcome [4] 0 0
Percentage of Participants with Adverse Events
Timepoint [4] 0 0
Baseline until up to 90 days after end of treatment (approximately 99 months)
Secondary outcome [5] 0 0
Serum Concentration of Atezolizumab
Timepoint [5] 0 0
At pre-defined intervals from Cycle 1, Day 1, through end of treatment (approximately 1 year).
Secondary outcome [6] 0 0
Incidence of ADA Response to Atezolizumab
Timepoint [6] 0 0
At pre-defined intervals from Cycle 1, Day 1, through end of treatment (approximately 1 year).

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/03/2024
Sample size
Target
Accrual to date
Final
406
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
St George Hospital - Kogarah
Recruitment hospital [2] 0 0
Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Center - North Melbourne
Recruitment hospital [4] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [3] 0 0
3051 - North Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
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California
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Florida
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Georgia
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Kansas
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Massachusetts
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Montana
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Ohio
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Virginia
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Belgium
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Namur
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BA
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Brazil
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PE
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Brazil
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RJ
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RS
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SP
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Canada
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Alberta
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Canada
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Manitoba
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Canada
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Ontario
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China
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Beijing
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China
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Chengdu
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China
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Fuzhou
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China
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Shanghai City
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China
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Shanghai
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China
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Tianjin
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China
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Wuhan City
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China
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Zhejiang
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France
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Avignon
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France
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Dijon
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France
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Lyon
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France
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Marseille
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France
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Montpellier Cedex 5
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France
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Paris
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France
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Pessac
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France
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St Mande
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France
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VILLEJUIF Cedex
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Germany
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Bonn
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Germany
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Freiburg
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Germany
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München
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Germany
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Rostock
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Hungary
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Budapest
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Hungary
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Pécs
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India
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Haryana
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India
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Maharashtra
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Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Toscana
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Italy
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Veneto
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Aichi
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Chiba
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Fukuoka
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Hokkaido
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Hyogo
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Miyagi
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Japan
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Okayama
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Osaka
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Japan
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Shizuoka
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Japan
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Tokyo
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Korea, Republic of
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Seongnam-si
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Seoul
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Gdansk
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Gliwice
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Coimbra
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Porto
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Krasnodar
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Russian Federation
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Moskovskaja Oblast
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Sankt Petersburg
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Sverdlovsk
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Novosibirsk
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Omsk
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Tomsk
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George
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Pretoria
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Barcelona
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Sevilla
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Valencia
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Taichung
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Tainan
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Taipei
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Taiwan
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Zhongzheng Dist.
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Thailand
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Bangkok
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Thailand
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Songkhla
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Turkey
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Ankara
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Kar?iyaka
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Ukraine
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Kharkiv Governorate
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Ukraine
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Podolia Governorate
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Ukraine
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Ivano-Frankivsk
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Kiev
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Ukraine
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Kryvyi Rih
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Ukraine
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Lviv
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Ukraine
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Sumy
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United Kingdom
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Aberdeen
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United Kingdom
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Cardiff
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United Kingdom
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London
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Plymouth
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United Kingdom
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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)
Trial website
https://clinicaltrials.gov/ct2/show/NCT03452137
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03452137