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

NCT03452137 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: WO402422017-003302-40
• Study Type: interventional
• Target: 406
• Locations: 23 countries
• Sites: 135

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)

Conditions

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

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (10)

• Overall Survival (OS)

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

• Independent Review Facility (IRF) Assessed EFS

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

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

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

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

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

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

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

Study Arms (2)

Atezolizumab

ACTIVE COMPARATOR

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

Drug: Atezolizumab

Placebo

EXPERIMENTAL

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

Drug: Placebo

Interventions

Atezolizumab DRUG

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

Atezolizumab

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (135)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

University of California San Diego Medical Center; Moores Cancer Center

La Jolla, California, 92093, United States

Location

UCLA Hematology/Oncology

Santa Monica, California, 90404, United States

Location

Miami Cancer Institute of Baptist Health, Inc.

Miami, Florida, 33176, United States

Location

Woodlands Medical Specialists, P.A.

Pensacola, Florida, 32503, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30329, United States

Location

Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

Marietta, Georgia, 30060, United States

Location

Cancer Center of Kansas

Wichita, Kansas, 67214-3728, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Billings Clinic Research Center

Billings, Montana, 59101, United States

Location

Cleveland Clinic; Taussig Cancer Institute

Cleveland, Ohio, 44195, United States

Location

Blue Ridge Cancer Care

Roanoke, Virginia, 24014, United States

Location

St George Hospital

Kogarah, New South Wales, 2217, Australia

Location

Adelaide Cancer Centre

Kurralta Park, South Australia, 5037, Australia

Location

Peter MacCallum Cancer Center

North Melbourne, Victoria, 3051, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Clinique Ste-Elisabeth

Namur, 5000, Belgium

Location

Santa Casa de Misericordia de Salvador

Salvador, Estado de Bahia, 40050-410, Brazil

Location

Hospital do Cancer de Pernambuco - HCP

Recife, Pernambuco, 50040-000, Brazil

Location

Instituto Nacional de Cancer - INCa; Oncologia

Rio de Janeiro, Rio de Janeiro, 20560-120, Brazil

Location

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, 90040-373, Brazil

Location

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Faculdade de Medicina do ABC - FMABC

Santo André, São Paulo, 09060-650, Brazil

Location

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, 01246-000, Brazil

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Cancer Care Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Beijing Cancer Hospital

Beijing, 100142, China

Location

West China Hospital, Sichuan University

Chengdu, 610041, China

Location

Fujian Cancer Hospital

Fuzhou, 350014, China

Location

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

Shanghai, 200011, China

Location

Fudan University Shanghai Cancer Center

Shanghai, 200120, China

Location

Shanghai East Hospital

Shanghai, China

Location

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430023, China

Location

Zhejiang Cancer Hospital

Zhejiang, 310022, China

Location

Institut Sainte Catherine

Avignon, 84082, France

Location

Centre Georges Francois Leclerc

Dijon, 21000, France

Location

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

Lyon, 69373, France

Location

Hopital Timone Adultes; Oncologie Medicale Et Usp

Marseille, 13385, France

Location

ICM; Radiotherapie

Montpellier, 34298, France

Location

Hopital Tenon; Oncologie Radiotherapie

Paris, 75970, France

Location

CHU Bordeaux

Pessac, 33604, France

Location

Hôpitaux D'Instruction Des Armees Begin

Saint-Mandé, 94160, France

Location

Gustave Roussy Cancer Campus; Radiotherapie

Villejuif, 94805, France

Location

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

Bonn, 53127, Germany

Location

Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde

Freiburg im Breisgau, 79106, Germany

Location

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

München, 81377, Germany

Location

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

Rostock, 18059, Germany

Location

Orszagos Onkologial Intezet; Onkologiai Osztaly X

Budapest, 1122, Hungary

Location

Budapesti Uzsoki Utcai Kórház

Budapest, 1145, Hungary

Location

Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

Pécs, 7623, Hungary

Location

Medanta-The Medicity

Gurgaon, Haryana, 122001, India

Location

Tata Memorial Hospital; Dept of Medical Oncology

Mumbai, Maharashtra, 400012, India

Location

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

Napoli, Campania, 80131, Italy

Location

Ospedale Umberto I ASL di Ravenna Presidio Ospedaliero di Lugo

Lugo, Emilia-Romagna, 48022, Italy

Location

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

Meldola, Emilia-Romagna, 47014, Italy

Location

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

Rome, Lazio, 00161, Italy

Location

Ospedale Civile; Servizio Oncologia

Savona, Liguria, 17100, Italy

Location

Spedali Civili di Brescia

Brescia, Lombardy, 25123, Italy

Location

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

Milan, Lombardy, 20133, Italy

Location

Asst Santi Paolo E Carlo; Unita Operativa Di Oncologia Medica

Milan, Lombardy, 20142, Italy

Location

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

Rozzano, Lombardy, 20089, Italy

Location

Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

Florence, Tuscany, 50134, Italy

Location

IOV - Istituto Oncologico Veneto IRCCS

Padua, Veneto, 35128, Italy

Location

Aichi Cancer Center Hospital

Aichi, 464-8681, Japan

Location

National Cancer Center Hospital East

Chiba, 277-8577, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Hokkaido University Hospital

Hokkaido, 060-8648, Japan

Location

Kobe University Hospital

Hyōgo, 650-0017, Japan

Location

Miyagi Cancer Center

Miyagi, 981-1293, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Osaka International Cancer Institute

Osaka, 541-8567, Japan

Location

Shizuoka Cancer Center

Shizuoka, 411-8777, Japan

Location

National Cancer Center Hospital

Tokyo, 104-0045, Japan

Location

The Jikei University Hospital

Tokyo, 105-8471, Japan

Location

Tokyo Medical and Dental University Hospital

Tokyo, 113-8519, Japan

Location

The Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan

Location

Tokyo Medical University Hospital

Tokyo, 160-0023, Japan

Location

Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

Gdansk, 80-214, Poland

Location

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

Gliwice, 44-101, Poland

Location

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

Warsaw, 02-781, Poland

Location

IPO de Coimbra; Servico de Oncologia Medica

Coimbra, 3000-075, Portugal

Location

Hospital de Santa Maria; Servico de Oncologia Medica

Lisbon, 1649-035, Portugal

Location

IPO do Porto; Servico de Oncologia Medica

Porto, 4200-072, Portugal

Location

Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy

Krasnoyarsk, Krasnodarskiy Kray, 660133, Russia

Location

Moscow City Oncology Hospital #62

Moscovskaya Oblast, Moscow Oblast, 143423, Russia

Location

Main Military Clinical Hospital named after N.N. Burdenko

Moscow, Moscow Oblast, 105229, Russia

Location

P.A. Herzen Oncological Inst. ; Oncology

Moscow, Moscow Oblast, 125248, Russia

Location

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

Moskva, Moscow Oblast, 119435, Russia

Location

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

Moskva, Moscow Oblast, 125367, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

Sverdlovsk Regional Oncology Dispensary; Chemotherapy

Yekaterinburg, Sverdlovsk Oblast, 620905, Russia

Location

Novosibirsk Regional Oncological Dispancer

Novosibirsk, 630108, Russia

Location

BHI of Omsk region Clinical Oncology Dispensary

Omsk, 644013, Russia

Location

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

Tomsk, 634028, Russia

Location

Tygerberg Hospital; Oncology Dept

Cape Town, 7530, South Africa

Location

GVI Oncology Outeniqua Unit

George, 6530, South Africa

Location

The Oncology Centre; Haematology - Radiation Oncology

Mayville, 4001, South Africa

Location

Steve Biko Academic Hospital; Oncology

Pretoria, 0002, South Africa

Location

Seoul National University Bundang Hospital

Seongnam-si, 463-707, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

Badalona, Barcelona, 08916, Spain

Location

Insititut Catala D'Oncologia

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital Clínic i Provincial; Servicio de Hematología y Oncología

Barcelona, 08036, Spain

Location

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

Madrid, 28009, Spain

Location

Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

Salamanca, 37007, Spain

Location

Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia

Seville, 41014, Spain

Location

Hospital Universitario la Fe; Servicio de Oncologia

Valencia, 46026, Spain

Location

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

Taichung, 404, Taiwan

Location

Taichung Veterans General Hospital; Radiation Oncology

Taichung, Taiwan

Location

National Cheng Kung University Hospital; Oncology

Tainan, 00704, Taiwan

Location

Division of Hematology and Oncology, Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

National Taiwan University Hospital; Oncology

Zhongzheng Dist., 10048, Taiwan

Location

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

Bangkok, 10400, Thailand

Location

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

Bangkok, 10700, Thailand

Location

Songklanagarind Hospital; Department of Oncology

Songkhla, 90110, Thailand

Location

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, 06100, Turkey (Türkiye)

Location

Dr. Abdurrahman Yurtarslan Oncology Hospital; 2nd Oncology Clinic

Ankara, 06200, Turkey (Türkiye)

Location

Gazi University Medical Faculty, Oncology Hospital

Ankara, 06500, Turkey (Türkiye)

Location

?zmir Medical Point; Oncology

Kar?iyaka, 35575, Turkey (Türkiye)

Location

Municipal Noncommercial Institution Regional Center of Oncology

Kharkiv, Kharkiv Governorate, 61070, Ukraine

Location

Vinnytsya Regional Clinical Oncology Dispensary

Vinnytsia, Podolia Governorate, 21029, Ukraine

Location

Ivano-Frankivsk Regional Oncology Center

Ivano-Frankivsk, 76018, Ukraine

Location

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

Kiev, 03115, Ukraine

Location

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

Kryvyi Rih, 50048, Ukraine

Location

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

Lviv, 79031, Ukraine

Location

RCI Sumy Regional Clinical Oncological Dispensary

Sumy, 40005, Ukraine

Location

Aberdeen Royal Infirmary; Medical Oncology Dept

Aberdeen, AB25 2ZN, United Kingdom

Location

Velindre Cancer Centre

Cardiff, CF14 2TL, United Kingdom

Location

The Royal Marsden Hospital, Fulham

London, SW3 6JJ, United Kingdom

Location

Derriford Hospital

Plymouth, PL6 8BT, United Kingdom

Location

Royal Marsden NHS Foundation Trust

Sutton, SM2 5PT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40079944 DERIVED

MeSH Terms

Interventions

atezolizumab

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2018
• First Posted: March 2, 2018
• Study Start: April 3, 2018
• Primary Completion: September 27, 2023
• Study Completion: March 6, 2024
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-09

Locations

KR (4); TH (3); ES (7); JP (14); ZA (4); US (12); TU (4); UA (7); BE (1); TW (5); HU (3); CA (3); IN (2); IT (11); PL (3); DE (4); PT (3); BR (7); GB (5); CN (9); RU (11); AU (4); FR (9)