Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Clinical Trial
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
| Verified date | April 2024 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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)
| Status | Terminated |
| Enrollment | 406 |
| Est. completion date | March 6, 2024 |
| Est. primary completion date | September 27, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | St George Hospital | Kogarah | New South Wales |
| Australia | Adelaide Cancer Centre | Kurralta Park | South Australia |
| Australia | Sir Charles Gairdner Hospital | Nedlands | Western Australia |
| Australia | Peter MacCallum Cancer Center | North Melbourne | Victoria |
| Belgium | Clinique Ste-Elisabeth | Namur | |
| Brazil | Hospital Nossa Senhora da Conceicao | Porto Alegre | RS |
| Brazil | Hospital Sao Lucas - PUCRS | Porto Alegre | RS |
| Brazil | Hospital do Cancer de Pernambuco - HCP | Recife | PE |
| Brazil | Instituto Nacional de Cancer - INCa; Oncologia | Rio de Janeiro | RJ |
| Brazil | Santa Casa de Misericordia de Salvador | Salvador | BA |
| Brazil | Faculdade de Medicina do ABC - FMABC | Santo Andre | SP |
| Brazil | Instituto do Cancer do Estado de Sao Paulo - ICESP | Sao Paulo | SP |
| Canada | Cross Cancer Institute | Edmonton | Alberta |
| Canada | London Health Sciences Centre | London | Ontario |
| Canada | Cancer Care Manitoba | Winnipeg | Manitoba |
| China | Beijing Cancer Hospital | Beijing | |
| China | West China Hospital, Sichuan University | Chengdu | |
| China | Fujian Cancer Hospital | Fuzhou | |
| China | Shanghai East Hospital | Shanghai | |
| China | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | |
| China | Fudan University Shanghai Cancer Center | Shanghai City | |
| China | Tianjin Medical University General Hospital | Tianjin | |
| China | Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan City | |
| China | Zhejiang Cancer Hospital | Zhejiang | |
| France | Institut Sainte Catherine | Avignon | |
| France | Centre Georges Francois Leclerc | Dijon | |
| France | CENTRE LEON BERARD; Département d?Hématologie et d?Oncologie | Lyon | |
| France | Hopital Timone Adultes; Oncologie Medicale Et Usp | Marseille | |
| France | ICM; Radiotherapie | Montpellier Cedex 5 | |
| France | Hopital Tenon; Oncologie Radiotherapie | Paris | |
| France | CHU Bordeaux | Pessac | |
| France | Hôpitaux D'Instruction Des Armees Begin | St Mande | |
| France | Gustave Roussy Cancer Campus; Radiotherapie | VILLEJUIF Cedex | |
| Germany | Universitätsklinikum Bonn; Med. Klinik und Poliklinik III; Hämatologie, Onkologie und Rheumatologie | Bonn | |
| Germany | Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde | Freiburg | |
| Germany | Klinikum d. Uni. München; Campus Großhadern; Klinik und Poliklinik f. Strahlenthera. und Radioonko | München | |
| Germany | Universitätsmedizin Rostock, Klinik und Poliklinik für Strahlentherapie; Zentrum für Radiologie | Rostock | |
| Hungary | Budapesti Uzsoki Utcai Kórház | Budapest | |
| Hungary | Orszagos Onkologial Intezet; Onkologiai Osztaly X | Budapest | |
| Hungary | Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet | Pécs | |
| India | Medanta-The Medicity | Gurgaon | Haryana |
| India | Tata Memorial Hospital; Dept of Medical Oncology | Mumbai | Maharashtra |
| Italy | Spedali Civili di Brescia | Brescia | Lombardia |
| Italy | Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia | Firenze | Toscana |
| Italy | Ospedale Umberto I ASL di Ravenna Presidio Ospedaliero di Lugo | Lugo | Emilia-Romagna |
| Italy | IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica | Meldola | Emilia-Romagna |
| Italy | Asst Santi Paolo E Carlo; Unita Operativa Di Oncologia Medica | Milano | Lombardia |
| Italy | Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo | Milano | Lombardia |
| Italy | Istituto Nazionale Tumori Fondazione G. Pascale; S.C. Oncol. Medica Testa-Collo e Sarcoma | Napoli | Campania |
| Italy | IOV - Istituto Oncologico Veneto IRCCS | Padova | Veneto |
| Italy | Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche | Roma | Lazio |
| Italy | Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia | Rozzano | Lombardia |
| Italy | Ospedale Civile; Servizio Oncologia | Savona | Liguria |
| Japan | Aichi Cancer Center Hospital | Aichi | |
| Japan | National Cancer Center Hospital East | Chiba | |
| Japan | National Hospital Organization Kyushu Cancer Center | Fukuoka | |
| Japan | Hokkaido University Hospital | Hokkaido | |
| Japan | Kobe University Hospital | Hyogo | |
| Japan | Miyagi Cancer Center | Miyagi | |
| Japan | Okayama University Hospital | Okayama | |
| Japan | Osaka International Cancer Institute | Osaka | |
| Japan | Shizuoka Cancer Center | Shizuoka | |
| Japan | National Cancer Center Hospital | Tokyo | |
| Japan | The Cancer Institute Hospital of JFCR | Tokyo | |
| Japan | The Jikei University Hospital | Tokyo | |
| Japan | Tokyo Medical and Dental University Hospital | Tokyo | |
| Japan | Tokyo Medical University Hospital | Tokyo | |
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Poland | Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii | Gdansk | |
| Poland | Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter. | Gliwice | |
| Poland | Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowotworów G?owy i Szyi | Warszawa | |
| Portugal | IPO de Coimbra; Servico de Oncologia Medica | Coimbra | |
| Portugal | Hospital de Santa Maria; Servico de Oncologia Medica | Lisboa | |
| Portugal | IPO do Porto; Servico de Oncologia Medica | Porto | |
| Russian Federation | Sverdlovsk Regional Oncology Dispensary; Chemotherapy | Ekaterinburg | Sverdlovsk |
| Russian Federation | Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy | Krasnoyarsk | Krasnodar |
| Russian Federation | Moscow City Oncology Hospital #62 | Moscovskaya Oblast | Moskovskaja Oblast |
| Russian Federation | Main Military Clinical Hospital named after N.N. Burdenko | Moscow | Moskovskaja Oblast |
| Russian Federation | P.A. Herzen Oncological Inst. ; Oncology | Moscow | Moskovskaja Oblast |
| Russian Federation | First MSMU n.a. Sechenov Univercity Hospital 1; Plastic surgery | Moskva | Moskovskaja Oblast |
| Russian Federation | FSAI Treatment and rehabilitation Centre Ministry of Health; Clinical research and chemotherapy. | Moskva | Moskovskaja Oblast |
| Russian Federation | Novosibirsk Regional Oncological Dispancer | Novosibirsk | |
| Russian Federation | BHI of Omsk region Clinical Oncology Dispensary | Omsk | |
| Russian Federation | S-Pb clinical scientific practical center of specialized kinds of medical care (oncological) | Saint-Petersburg | Sankt Petersburg |
| Russian Federation | Tomsk scientific research institute of oncology SO RAMN, PAD; Pathological | Tomsk | |
| South Africa | Tygerberg Hospital; Oncology Dept | Cape Town | |
| South Africa | GVI Oncology Outeniqua Unit | George | |
| South Africa | The Oncology Centre; Haematology - Radiation Oncology | Mayville | |
| South Africa | Steve Biko Academic Hospital; Oncology | Pretoria | |
| Spain | Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia | Badalona | Barcelona |
| Spain | Hospital Clínic i Provincial; Servicio de Hematología y Oncología | Barcelona | |
| Spain | Insititut Catala D'Oncologia | Hospitalet de Llobregat | Barcelona |
| Spain | Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | |
| Spain | Hospital Clinico Universitario de Salamanca; Servicio de Oncologia | Salamanca | |
| Spain | Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia | Sevilla | |
| Spain | Hospital Universitario la Fe; Servicio de Oncologia | Valencia | |
| Taiwan | China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H | Taichung | |
| Taiwan | Taichung Veterans General Hospital; Radiation Oncology | Taichung | |
| Taiwan | National Cheng Kung University Hospital; Oncology | Tainan | |
| Taiwan | Division of Hematology and Oncology, Taipei Veterans General Hospital | Taipei | |
| Taiwan | National Taiwan University Hospital; Oncology | Zhongzheng Dist. | |
| Thailand | Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology | Bangkok | |
| Thailand | Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc | Bangkok | |
| Thailand | Songklanagarind Hospital; Department of Oncology | Songkhla | |
| Turkey | Dr. Abdurrahman Yurtarslan Oncology Hospital; 2nd Oncology Clinic | Ankara | |
| Turkey | Gazi University Medical Faculty, Oncology Hospital | Ankara | |
| Turkey | Hacettepe Universitesi Tip Fakultesi Hastanesi | Ankara | |
| Turkey | ?zmir Medical Point; Oncology | Kar?iyaka | |
| Ukraine | Ivano-Frankivsk Regional Oncology Center | Ivano-Frankivsk | |
| Ukraine | Municipal Noncommercial Institution Regional Center of Oncology | Kharkiv | Kharkiv Governorate |
| Ukraine | Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients | Kiev | |
| Ukraine | ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department | Kryvyi Rih | |
| Ukraine | Lviv State Oncology Regional Treatment and Diagnostic Centre; Department of hemotherapy | Lviv | |
| Ukraine | RCI Sumy Regional Clinical Oncological Dispensary | Sumy | |
| Ukraine | Vinnytsya Regional Clinical Oncology Dispensary | Vinnytsya | Podolia Governorate |
| United Kingdom | Aberdeen Royal Infirmary; Medical Oncology Dept | Aberdeen | |
| United Kingdom | Velindre Cancer Centre | Cardiff | |
| United Kingdom | The Royal Marsden Hospital, Fulham | London | |
| United Kingdom | Derriford Hospital | Plymouth | |
| United Kingdom | Royal Marsden NHS Foundation Trust | Sutton | |
| United States | Winship Cancer Institute of Emory University | Atlanta | Georgia |
| United States | Billings Clinic Research Center | Billings | Montana |
| United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
| United States | Cleveland Clinic; Taussig Cancer Institute | Cleveland | Ohio |
| United States | City of Hope National Medical Center | Duarte | California |
| United States | University of California San Diego Medical Center; Moores Cancer Center | La Jolla | California |
| United States | Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital | Marietta | Georgia |
| United States | Miami Cancer Institute of Baptist Health, Inc. | Miami | Florida |
| United States | Woodlands Medical Specialists, P.A. | Pensacola | Florida |
| United States | Blue Ridge Cancer Care | Roanoke | Virginia |
| United States | UCLA Hematology/Oncology | Santa Monica | California |
| United States | Cancer Center of Kansas | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
United States, Australia, Belgium, Brazil, Canada, China, France, Germany, Hungary, India, Italy, Japan, Korea, Republic of, Poland, Portugal, Russian Federation, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Investigator-assessed Event Free Survival (EFS) | 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 | Overall Survival (OS) after Randomization | Randomization to death from any cause, through the end of study (approximately 99 months) | ||
| Secondary | Independent Review Facility-assessed Event Free Survival (IRF-assessed EFS) | 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 | 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 | Baseline to 3 Months and 6 Months | ||
| Secondary | Percentage of Participants with Adverse Events | Baseline until up to 90 days after end of treatment (approximately 99 months) | ||
| Secondary | Serum Concentration of Atezolizumab | At pre-defined intervals from Cycle 1, Day 1, through end of treatment (approximately 1 year). | ||
| Secondary | Incidence of ADA Response to Atezolizumab | At pre-defined intervals from Cycle 1, Day 1, through end of treatment (approximately 1 year). |