AzTrials
AzTrials

Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)Phase 3IMvoke010NCT03452137

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

A Phase 3 study testing Atezolizumab in people with Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN), run by Hoffmann-La Roche at 135 sites in 23 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
406 participants
Where
135 sitesin 23 countries
Study dates
3 Apr 2018to 6 Mar 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

135 sites in 23 countries.

135 sites in 23 countries

Japan14 sites

  • Aichi Cancer Center Hospital

    Aichi, 464-8681

  • National Cancer Center Hospital East

    Chiba, 277-8577

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Hokkaido University Hospital

    Hokkaido, 060-8648

  • Kobe University Hospital

    Hyōgo, 650-0017

  • Miyagi Cancer Center

    Miyagi, 981-1293

  • Okayama University Hospital

    Okayama, 700-8558

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • National Cancer Center Hospital

    Tokyo, 104-0045

  • The Jikei University Hospital

    Tokyo, 105-8471

  • Tokyo Medical and Dental University Hospital

    Tokyo, 113-8519

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

  • Tokyo Medical University Hospital

    Tokyo, 160-0023

Other trials in Japan

United States12 sites

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30329

  • Billings Clinic Research Center

    Billings, Montana, 59101

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Cleveland Clinic; Taussig Cancer Institute

    Cleveland, Ohio, 44195

  • City of Hope National Medical Center

    Duarte, California, 91010

  • University of California San Diego Medical Center; Moores Cancer Center

    La Jolla, California, 92093

  • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

    Marietta, Georgia, 30060

  • Miami Cancer Institute of Baptist Health, Inc.

    Miami, Florida, 33176

  • Woodlands Medical Specialists, P.A.

    Pensacola, Florida, 32503

  • Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

  • UCLA Hematology/Oncology

    Santa Monica, California, 90404

  • Cancer Center of Kansas

    Wichita, Kansas, 67214-3728

Other trials in United States

Italy11 sites

  • Spedali Civili di Brescia

    Brescia, Lombardy, 25123

  • Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

    Florence, Tuscany, 50134

  • Ospedale Umberto I ASL di Ravenna Presidio Ospedaliero di Lugo

    Lugo, Emilia-Romagna, 48022

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

    Meldola, Emilia-Romagna, 47014

  • Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo

    Milan, Lombardy, 20133

  • Asst Santi Paolo E Carlo; Unita Operativa Di Oncologia Medica

    Milan, Lombardy, 20142

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

    Naples, Campania, 80131

  • IOV - Istituto Oncologico Veneto IRCCS

    Padova, Veneto, 35128

  • Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche

    Rome, Lazio, 00161

  • Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

    Rozzano, Lombardy, 20089

  • Ospedale Civile; Servizio Oncologia

    Savona, Liguria, 17100

Other trials in Italy

Russia11 sites

  • Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy

    Krasnoyarsk, Krasnodarskiy Kray, 660133

  • Moscow City Oncology Hospital #62

    Moscovskaya Oblast, Moscow Oblast, 143423

  • Main Military Clinical Hospital named after N.N. Burdenko

    Moscow, Moscow Oblast, 105229

  • P.A. Herzen Oncological Inst. ; Oncology

    Moscow, Moscow Oblast, 125248

  • First MSMU n.a. Sechenov Univercity Hospital 1; Plastic surgery

    Moskva, Moscow Oblast, 119435

  • FSAI Treatment and rehabilitation Centre Ministry of Health; Clinical research and chemotherapy.

    Moskva, Moscow Oblast, 125367

  • Novosibirsk Regional Oncological Dispancer

    Novosibirsk, 630108

  • BHI of Omsk region Clinical Oncology Dispensary

    Omsk, 644013

  • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

    Saint Petersburg, Sankt-Peterburg, 197758

  • Tomsk scientific research institute of oncology SO RAMN, PAD; Pathological

    Tomsk, 634028

  • Sverdlovsk Regional Oncology Dispensary; Chemotherapy

    Yekaterinburg, Sverdlovsk Oblast, 620905

Other trials in Russia

China9 sites

  • Beijing Cancer Hospital

    Beijing, 100142

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • Fujian Cancer Hospital

    Fuzhou, 350014

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 200011

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120

  • Shanghai East Hospital

    Shanghai

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430023

  • Zhejiang Cancer Hospital

    Zhejiang, 310022

Other trials in China

France9 sites

  • Institut Sainte Catherine

    Avignon, 84082

  • Centre Georges Francois Leclerc

    Dijon, 21000

  • CENTRE LEON BERARD; Département d?Hématologie et d?Oncologie

    Lyon, 69373

  • Hopital Timone Adultes; Oncologie Medicale Et Usp

    Marseille, 13385

  • ICM; Radiotherapie

    Montpellier, 34298

  • Hopital Tenon; Oncologie Radiotherapie

    Paris, 75970

  • CHU Bordeaux

    Pessac, 33604

  • Hôpitaux D'Instruction Des Armees Begin

    Saint-Mandé, 94160

  • Gustave Roussy Cancer Campus; Radiotherapie

    Villejuif, 94805

Other trials in France

Brazil7 sites

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 90040-373

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital do Cancer de Pernambuco - HCP

    Recife, Pernambuco, 50040-000

  • Instituto Nacional de Cancer - INCa; Oncologia

    Rio de Janeiro, Rio de Janeiro, 20560-120

  • Santa Casa de Misericordia de Salvador

    Salvador, Estado de Bahia, 40050-410

  • Faculdade de Medicina do ABC - FMABC

    Santo André, São Paulo, 09060-650

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000

Other trials in Brazil

Spain7 sites

  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

    Badalona, Barcelona, 08916

  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología

    Barcelona, 08036

  • Insititut Catala D'Oncologia

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

    Madrid, 28009

  • Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

    Salamanca, 37007

  • Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia

    Seville, 41014

  • Hospital Universitario la Fe; Servicio de Oncologia

    Valencia, 46026

Other trials in Spain

Ukraine7 sites

  • Ivano-Frankivsk Regional Oncology Center

    Ivano-Frankivsk, 76018

  • Municipal Noncommercial Institution Regional Center of Oncology

    Kharkiv, Kharkiv Governorate, 61070

  • Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients

    Kiev, 03115

  • ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department

    Kryvyi Rih, 50048

  • Lviv State Oncology Regional Treatment and Diagnostic Centre; Department of hemotherapy

    Lviv, 79031

  • RCI Sumy Regional Clinical Oncological Dispensary

    Sumy, 40005

  • Vinnytsya Regional Clinical Oncology Dispensary

    Vinnytsia, Podolia Governorate, 21029

Other trials in Ukraine

Taiwan5 sites

  • China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H

    Taichung, 404

  • Taichung Veterans General Hospital; Radiation Oncology

    Taichung

  • National Cheng Kung University Hospital; Oncology

    Tainan, 00704

  • Division of Hematology and Oncology, Taipei Veterans General Hospital

    Taipei, 112

  • National Taiwan University Hospital; Oncology

    Zhongzheng Dist., 10048

Other trials in Taiwan

United Kingdom5 sites

  • Aberdeen Royal Infirmary; Medical Oncology Dept

    Aberdeen, AB25 2ZN

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

  • The Royal Marsden Hospital, Fulham

    London, SW3 6JJ

  • Derriford Hospital

    Plymouth, PL6 8BT

  • Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT

Other trials in United Kingdom

Australia4 sites

  • St George Hospital

    Kogarah, New South Wales, 2217

  • Adelaide Cancer Centre

    Kurralta Park, South Australia, 5037

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Peter MacCallum Cancer Center

    North Melbourne, Victoria, 3051

Other trials in Australia

Germany4 sites

  • Universitätsklinikum Bonn; Med. Klinik und Poliklinik III; Hämatologie, Onkologie und Rheumatologie

    Bonn, 53127

  • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde

    Freiburg im Breisgau, 79106

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

    München, 81377

  • Universitätsmedizin Rostock, Klinik und Poliklinik für Strahlentherapie; Zentrum für Radiologie

    Rostock, 18059

Other trials in Germany

South Africa4 sites

  • Tygerberg Hospital; Oncology Dept

    Cape Town, 7530

  • GVI Oncology Outeniqua Unit

    George, 6530

  • The Oncology Centre; Haematology - Radiation Oncology

    Mayville, 4001

  • Steve Biko Academic Hospital; Oncology

    Pretoria, 0002

Other trials in South Africa

South Korea4 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Turkey (Türkiye)4 sites

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    Ankara, 06100

  • Dr. Abdurrahman Yurtarslan Oncology Hospital; 2nd Oncology Clinic

    Ankara, 06200

  • Gazi University Medical Faculty, Oncology Hospital

    Ankara, 06500

  • ?zmir Medical Point; Oncology

    Kar?iyaka, 35575

Other trials in Turkey (Türkiye)

Canada3 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • London Health Sciences Centre

    London, Ontario, N6A 4L6

  • Cancer Care Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Hungary3 sites

  • Orszagos Onkologial Intezet; Onkologiai Osztaly X

    Budapest, 1122

  • Budapesti Uzsoki Utcai Kórház

    Budapest, 1145

  • Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

    Pécs, 7623

Other trials in Hungary

Poland3 sites

  • Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

    Gdansk, 80-214

  • Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.

    Gliwice, 44-101

  • Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowotworów G?owy i Szyi

    Warsaw, 02-781

Other trials in Poland

Portugal3 sites

  • IPO de Coimbra; Servico de Oncologia Medica

    Coimbra, 3000-075

  • Hospital de Santa Maria; Servico de Oncologia Medica

    Lisbon, 1649-035

  • IPO do Porto; Servico de Oncologia Medica

    Porto, 4200-072

Other trials in Portugal

Thailand3 sites

  • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

    Bangkok, 10400

  • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

    Bangkok, 10700

  • Songklanagarind Hospital; Department of Oncology

    Songkhla, 90110

Other trials in Thailand

India2 sites

  • Medanta-The Medicity

    Gurgaon, Haryana, 122001

  • Tata Memorial Hospital; Dept of Medical Oncology

    Mumbai, Maharashtra, 400012

Other trials in India

Belgium1 site

  • Clinique Ste-Elisabeth

    Namur, 5000

Other trials in Belgium

About this study

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

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)

Being tested
Atezolizumab, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

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

  • PlaceboDrug

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

Study groups in NCT03452137
Study groupRoleWhat they receive
AtezolizumabActive comparatorParticipants will receive Atezolizumab for 16 cycles, or up to 1 year (whichever occurs first)
Receives: Drug: Atezolizumab
PlaceboExperimentalParticipants will receive Placebo for 16 cycles, or up to 1 year (whichever occurs first).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Investigator-Assessed Event-Free Survival (INV-assessed EFS)

    EFS was defined as the time from randomization to the first documented disease recurrence (per unequivocal radiographic evidence of local recurrence, new second primary SCCHN lesion, or development of distant metastasis), or disease progression [per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)] per assessment by investigator, or death from any cause, whichever occurred first. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD on study (including baseline). Participants without disease recurrence, progression or death at the time of analysis were censored at the time of the last tumor assessment. EFS was estimated using the Kaplan-Meier method.

    Measured: Randomization to the first documented disease recurrence, disease progression or death from any cause, whichever occurs first (up to 5 years)

Secondary outcomes (10)

  1. Overall Survival (OS)

    OS was defined as the time from randomization to death from any cause. Data from participants who were alive at the time of the analysis was censored as of the last date they were known to be alive. OS was estimated using the Kaplan-Meier method.

    Measured: Randomization to death from any cause (up to 5 years, 5 months)

  2. Independent Review Facility (IRF) Assessed EFS

    EFS was defined as the time from randomization to the first documented disease recurrence (per unequivocal radiographic evidence of local recurrence, new second primary SCCHN lesion, or development of distant metastasis), or disease progression (per RECIST v1.1) per assessment by IRF, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Participants without disease recurrence, progression or death at the time of analysis were censored at the time of the last tumor assessment. EFS was estimated using the Kaplan-Meier method.

    Measured: Randomization to the first documented disease recurrence, disease progression or death from any cause, whichever occurs first (up to 5 years)

  3. Percentage of Participants Event-Free for IRF-assessed EFS at 1, 2, 3, and 4 Years

    EFS was defined as the time from randomization to the first documented disease recurrence (per unequivocal radiographic evidence of local recurrence, new second primary SCCHN lesion, or development of distant metastasis), or disease progression (per RECIST v1.1) per assessment by IRF, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Participants without disease recurrence, progression or death at the time of analysis were censored at the time of the last tumor assessment. Kaplan-Meier approach was used to estimate percentage of participants who were event-free for EFS at 1, 2, 3 \& 4 years.

    Measured: From randomization to EFS event or date last known to be alive and event-free at 1, 2, 3, and 4 years

  4. Percentage of Participants Event-Free for INV-assessed EFS at 1, 2, 3, and 4 Years

    EFS was defined as the time from randomization to the first documented disease recurrence (per unequivocal radiographic evidence of local recurrence, new second primary SCCHN lesion, or development of distant metastasis), or disease progression (per RECIST v1.1) per assessment by the investigator, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Participants without disease recurrence, progression or death at the time of analysis were censored at the time of the last tumor assessment. Kaplan-Meier approach was used to estimate percentage of participants who were event-free for EFS at 1, 2, 3 \& 4 years.

    Measured: From randomization to EFS event or date last known to be alive and event-free at 1, 2, 3, and 4 years

  5. Percentage of Participants Event-Free for OS at 2, 3, and 5 Years

    OS was defined as the time from randomization to death from any cause. Data from participants who were alive at the time of the analysis was censored as of the last date they were known to be alive. Kaplan-Meier approach was used to estimate the percentage of participants who were event-free for OS at 2, 3 and 5 years.

    Measured: From randomization to OS event or date last known to be alive at 2, 3, and 5 Years

  6. 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

    EORTC QLQ-C30 scale consists of 30 questions that assess participant functioning (physical, emotional, role, cognitive, and social), symptoms (fatigue, nausea and vomiting, pain), global health/quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Change in PF was assessed using the PF scale, where participant responses to 5 questions about daily activities (strenuous activities, long walks, short walks, bed/chair rest \& needing help with eating, dressing, washing themselves, or using the toilet) was scored on a 4-point scale (1=Not at All to 4=Very Much). Scores were linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning.

    Measured: 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)

  7. Change From Baseline in Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30 Score

    EORTC QLQ-C30 scale consists of 30 questions that assess participant functioning (physical, emotional, role, cognitive, and social), symptom (fatigue, nausea and vomiting, pain), global health/quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Change in HRQoL was assessed using participant responses to questions regarding Global Health Status (Question 29: GHS; "How would you rate your overall health during the past week?") and QoL (Question 30: QoL; "How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized. Scores range from 0-100. A higher score indicates a better outcome.

    Measured: 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)

  8. Number of Participants With at Least One Adverse Event (AE)

    An AE is untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product.

    Measured: From first dose of study drug until 90 days after the last dose of study drug (up to 1 year, 3 months)

  9. Serum Concentration of Atezolizumab

    Measured: 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)

  10. Number of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab

    Number of participants positive for Treatment Emergent ADA is the number of post-baseline evaluable participants determined to have treatment induced ADA or treatment-enhanced ADA during the study period.

    Measured: Predose on Day 1 of Cycles 1, 2, 4, 8 and 16 (Cycle length=21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2018
  2. Study start3 Apr 2018
  3. Primary completion27 Sep 2023
  4. Study completion6 Mar 2024

Why it stopped: Decision to terminate the study as its primary endpoint of investigator-assessed event free survival (INV-EFS) was not met at its final EFS analysis. No new safety signals were identified.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03452137
Sponsor's protocol ID
WO40242
Other IDs
2017-003302-40, 2017
Acronym
IMvoke010
Status last verified
Sep 2024
First submitted
25 Feb 2018
Last updated
9 Oct 2024
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Haddad R, Fayette J, Teixeira M, Prabhash K, Mesia R, Kawecki A, Dechaphunkul A, Dinis J, Guo Y, Masuda M, Hsieh CY, Ghi MG, Vaz de Melo Sette C, Harrington K, Tahara M, Saba NF, Lau A, Jiang T, Yan Y, Ballinger M, Kaul M, Matheny C, Cuchelkar V, Wong DJ. Atezolizumab in High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck: A Randomized Clinical Trial. JAMA. 2025 May 13;333(18):1599-1607. doi: 10.1001/jama.2025.1483.

    PubMed 40079944

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab in people with Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN), run by Hoffmann-La Roche at 135 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 135 sites in Japan, United States, Italy, Russia, China and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigator-Assessed Event-Free Survival (INV-assessed EFS) (time frame: Randomization to the first documented disease recurrence, disease progression or death from any cause, whichever occurs first (up to 5 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03452137, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.

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