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
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Interventions
- Registration Number
- NCT04665843
- Lead Sponsor
- Hoffmann-La Roche
- 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
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 123
- Histologically or cytologically confirmed recurrent/metastatic SCCHN involving the oropharynx, oral cavity, larynx, or hypopharynx, that is considered incurable by local therapies
- Known results from human papillomavirus (HPV) status test for oropharyngeal carcinoma
- No prior systemic therapy for metastatic and/or recurrent SCCHN
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Tumor PD-L1 expression as determined by PD-L1 immunohistochemistry assay
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy >=12 weeks
Key
- Disease suitable for local therapy with curative intent
- Progressive or recurrent disease within 6 months of the last dose of curative intent systemic treatment for locally advanced SCCHN
- Rapidly progressing disease in the opinion of the treating investigator
- Grade >=2 unresolved toxicity related to surgery or other prior therapies
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- History of leptomeningeal disease
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- History of additional malignancy other than SCCHN within 5 years prior to randomization
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-TIGIT, anti-PD-L1, and anti-PD-1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents or systemic immunosuppressive medication
- Pregnancy or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atezolizumab + Tiragolumab Tiragolumab Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle. Atezolizumab + Placebo Placebo Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle. Atezolizumab + Tiragolumab Atezolizumab Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle. Atezolizumab + Placebo Atezolizumab Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.
- Primary Outcome Measures
Name Time Method Confirmed Objective Response Rate (ORR) Up to approximately 43 months
- Secondary Outcome Measures
Name Time Method Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab From baseline up to approximately 43 months Number of Participants With ADAs to Tiragolumab From baseline up to approximately 43 months Duration of Response (DOR) Up to approximately 43 months Progression-Free Survival (PFS) Up to approximately 43 months Overall Survival (OS) Up to approximately 43 months Progression-Free Survival Rate at 6 Months Month 6 Overall Survival Rate at 6 Months and 12 Months Month 6, Month 12 Time to Confirmed Deterioration (TTCD) in Patient-Reported Physical Functioning Up to approximately 43 months Percentage of Participants With Adverse Events (AEs) Up to approximately 43 months Minimum Serum Concentration (Cmin) of Atezolizumab Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months Cmax of Tiragolumab Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months Maximum Serum Concentration (Cmax) of Atezolizumab Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months Cmin of Tiragolumab Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months
Trial Locations
- Locations (44)
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Fakultni nemocnice v Motole
🇨🇿Praha 5, Czechia
Centre Francois Baclesse
🇫🇷Caen, France
Centre Leon Berard
🇫🇷Lyon, France
Institut Curie
🇫🇷Paris, France
Attiko Hospital University of Athens
🇬🇷Athens, Greece
Euromedical General Clinic of Thessaloniki
🇬🇷Thessaloniki, Greece
Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
ðŸ‡ðŸ‡ºKecskemet, Hungary
Pécsi Tudományegyetem
ðŸ‡ðŸ‡ºPécs, Hungary
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Lombardia, Italy
Azienda Ospedaliero-Universitaria Careggi
🇮🇹Firenze, Toscana, Italy
Uniwersyteckie Centrum Kliniczne
🇵🇱Gda?sk, Poland
Centrum Onkologii Ziemi Lubelskiej Im. ?W. Jana Z Dukli
🇵🇱Lublin, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
🇵🇱Poznan, Poland
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Spain
China Medical University Hospital
🇨🇳Taichung, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei City, Taiwan
National Taiwan University Hospital
🇨🇳Zhongzheng Dist., Taiwan
Ramathibodi Hospital
🇹ðŸ‡Bangkok, Thailand
Songklanagarind Hospital
🇹ðŸ‡Songkhla, Thailand
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
Masarykuv onkologicky ustav
🇨🇿Brno, Czechia
Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czechia
CHU Bordeaux
🇫🇷Bordeaux, France
Institut régional du Cancer Montpellier
🇫🇷Montpellier, France
Institut de Cancérologie de Lorraine
🇫🇷Vandoeuvre-Les-Nancy, France
Gy?r-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
ðŸ‡ðŸ‡ºGy?r, Hungary
Asst Degli Spedali Civili Di Brescia
🇮🇹Brescia, Lombardia, 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
Beskidzkie Centrum Onkologii- Szpital Miejski
🇵🇱Bielsko- Biala, Poland
Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
🇵🇱Lodz, Poland
Institut Catala d Oncologia Hospital Duran i Reynals
🇪🇸Barcelona, Spain
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
Royal Marsden NHS Foundation Trust
🇬🇧Sutton, United Kingdom