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Brief Title: A Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck
Official Title: A Phase II, Randomized, Double Blind Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Patients With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck
Study ID: NCT04665843
Brief Summary: The primary objective of this study is to evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo as first-line (1L) treatment in recurrent/metastatic PD-L1-positive squamous cell carcinoma of the head and neck (SCCHN) on the basis of confirmed objective response rate. In addition, safety, pharmacokinetics, immunogenicity of atezolizumab and tiragolumab will be evaluated.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Moores Cancer Center at UC San Diego Health, La Jolla, California, United States
UCLA, Los Angeles, California, United States
SCRI Florida Cancer Specialists PAN, Tallahassee, Florida, United States
Johns Hopkins Hospital, Baltimore, Maryland, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Tennessee Oncology - Nashville, Nashville, Tennessee, United States
MD Anderson Cancer Center; Oncology, Houston, Texas, United States
Masarykuv onkologicky ustav, Brno, , Czechia
Fakultni nemocnice Hradec Kralove, Hradec Kralove, , Czechia
Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol, Praha 5, , Czechia
Centre Francois Baclesse; Oncologie, Caen, , France
Centre Leon Berard; Departement Oncologie Medicale, Lyon, , France
Institut régional du Cancer Montpellier, Montpellier, , France
Institut Curie; Oncologie Medicale, Paris, , France
CHU Bordeaux, Pessac, , France
Institut de Cancérologie de Lorraine, Vandoeuvre-Les-Nancy, , France
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine, Athens, , Greece
Attiko Hospital University of Athens; 2Nd Dept. of Propaedeutic Medicine, Athens, , Greece
Periph. University General Hospital of Heraklion Crete; Oncology Department, Heraklion, , Greece
Euromedical General Clinic of Thessaloniki; Oncology Department, Thessaloniki, , Greece
Gy?r-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház, Gy?r, , Hungary
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet, Pécs, , Hungary
Asst Degli Spedali Civili Di Brescia, Brescia, Lombardia, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo, Milano, Lombardia, Italy
Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia, Firenze, Toscana, Italy
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Auckland City Hospital, Cancer and Blood Research, Auckland, , New Zealand
Christchurch Hospital NZ, Christchurch, , New Zealand
Tauranga Hospital, Clinical Trials Unit; BOP Clinical School, Tauranga, , New Zealand
Wellington Hospital, Wellington, , New Zealand
Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna, ?ód?, , Poland
Beskidzkie Centrum Onkologii- Szpital Miejski, Bielsko- Biala, , Poland
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii, Gdansk, , Poland
CENTRUM ONKOLOGII ZIEMI LUBELSKIEJ IM. ?W. JANA Z DUKLI; II Oddzia? Onkologii Klinicznej, Lublin, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu; Oddzia? Onkologii Klinicznej i Doswiadczalnej, Poznan, , Poland
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia, Badalona, Barcelona, Spain
Institut Catala d Oncologia Hospital Duran i Reynals, Barcelona, , Spain
Hospital Universitari i Politecnic La Fe; Oncologia, Valencia, , Spain
China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H, Taichung, , Taiwan
Taipei Veterans General Hospital; Department of Oncology, Taipei City, , Taiwan
National Taiwan University Hospital; Oncology, Zhongzheng Dist., , Taiwan
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc, Bangkok, , Thailand
Songklanagarind Hospital; Department of Oncology, Songkhla, , Thailand
Velindre Cancer Centre, Cardiff, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Guys and St Thomas NHS Foundation Trust, Guys Hospital, London, , United Kingdom
The Royal Marsden Hospital, Fulham, London, , United Kingdom
Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR