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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03452137
Ethics application status
Date submitted
25/02/2018
Date registered
2/03/2018
Date last updated
9/10/2024

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
IMvoke010
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 (INV-assessed EFS)
Timepoint [1] 0 0
Randomization to the first documented disease recurrence, disease progression or death from any cause, whichever occurs first (up to 5 years)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Randomization to death from any cause (up to 5 years, 5 months)
Secondary outcome [2] 0 0
Independent Review Facility (IRF) Assessed EFS
Timepoint [2] 0 0
Randomization to the first documented disease recurrence, disease progression or death from any cause, whichever occurs first (up to 5 years)
Secondary outcome [3] 0 0
Percentage of Participants Event-Free for IRF-assessed EFS at 1, 2, 3, and 4 Years
Timepoint [3] 0 0
From randomization to EFS event or date last known to be alive and event-free at 1, 2, 3, and 4 years
Secondary outcome [4] 0 0
Percentage of Participants Event-Free for INV-assessed EFS at 1, 2, 3, and 4 Years
Timepoint [4] 0 0
From randomization to EFS event or date last known to be alive and event-free at 1, 2, 3, and 4 years
Secondary outcome [5] 0 0
Percentage of Participants Event-Free for OS at 2, 3, and 5 Years
Timepoint [5] 0 0
From randomization to OS event or date last known to be alive at 2, 3, and 5 Years
Secondary outcome [6] 0 0
Change From Baseline in Physical Function (PF) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 (EORTC-QLQ-C30) Score
Timepoint [6] 0 0
Baseline, Day 1 of Cycles 2 to 16 (Cycle length = 21 days); study discontinuation visit (up to 1 year); Follow-up approximately every 3 months until disease recurrence or progression (up to approximately 4.5 years)
Secondary outcome [7] 0 0
Change From Baseline in Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30 Score
Timepoint [7] 0 0
Baseline, Day 1 of Cycles 2 to 16 (Cycle length = 21 days); study discontinuation visit (up to 1 year); Follow-up approximately every 3 months until disease recurrence or progression (up to approximately 4.5 years)
Secondary outcome [8] 0 0
Number of Participants With at Least One Adverse Event (AE)
Timepoint [8] 0 0
From first dose of study drug until 90 days after the last dose of study drug (up to 1 year, 3 months)
Secondary outcome [9] 0 0
Serum Concentration of Atezolizumab
Timepoint [9] 0 0
Predose and 0.5 hours post dose on Cycle 1 Day 1; Predose on Day 1 of Cycles 2, 4, 8, and 16 (Cycle length=21 days); study discontinuation visit (up to 1 year)
Secondary outcome [10] 0 0
Number of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab
Timepoint [10] 0 0
Predose on Day 1 of Cycles 1, 2, 4, 8 and 16 (Cycle length=21 days)

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
Stopped early
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
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Montana
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
Belgium
State/province [9] 0 0
Namur
Country [10] 0 0
Brazil
State/province [10] 0 0
BA
Country [11] 0 0
Brazil
State/province [11] 0 0
PE
Country [12] 0 0
Brazil
State/province [12] 0 0
RJ
Country [13] 0 0
Brazil
State/province [13] 0 0
RS
Country [14] 0 0
Brazil
State/province [14] 0 0
SP
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
Manitoba
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
China
State/province [18] 0 0
Beijing
Country [19] 0 0
China
State/province [19] 0 0
Chengdu
Country [20] 0 0
China
State/province [20] 0 0
Fuzhou
Country [21] 0 0
China
State/province [21] 0 0
Shanghai City
Country [22] 0 0
China
State/province [22] 0 0
Shanghai
Country [23] 0 0
China
State/province [23] 0 0
Tianjin
Country [24] 0 0
China
State/province [24] 0 0
Wuhan City
Country [25] 0 0
China
State/province [25] 0 0
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
State/province [34] 0 0
VILLEJUIF Cedex
Country [35] 0 0
Germany
State/province [35] 0 0
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
State/province [38] 0 0
Rostock
Country [39] 0 0
Hungary
State/province [39] 0 0
Budapest
Country [40] 0 0
Hungary
State/province [40] 0 0
Pécs
Country [41] 0 0
India
State/province [41] 0 0
Haryana
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India
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Maharashtra
Country [43] 0 0
Italy
State/province [43] 0 0
Campania
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Italy
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Emilia-Romagna
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Italy
State/province [45] 0 0
Lazio
Country [46] 0 0
Italy
State/province [46] 0 0
Liguria
Country [47] 0 0
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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Japan
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Aichi
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Miyagi
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Japan
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Okayama
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Japan
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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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Poland
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Gliwice
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Coimbra
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Lisboa
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Portugal
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Porto
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Russian Federation
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Krasnodar
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Russian Federation
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Moskovskaja Oblast
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Russian Federation
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Sankt Petersburg
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Russian Federation
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Sverdlovsk
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Russian Federation
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Tomsk
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George
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Mayville
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South Africa
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Pretoria
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Barcelona
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Madrid
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Salamanca
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Sevilla
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Valencia
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Taiwan
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Taichung
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Tainan
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Taiwan
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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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Turkey
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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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Ukraine
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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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United Kingdom
State/province [102] 0 0
Plymouth
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Sutton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03452137