Locally advanced squamous cell carcinoma of the head and neck (SCCHN) MedDRA version: 21.0 Level: PT Classification code 10041823 Term: Squamous cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
F. Hoffman-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age >= 18 years - Ability to comply with the study protocol, in the investigator's judgment -Histologically or cytologically confirmed squamous cell carcinoma of the head and neck SCCHN - Human papillomavirus (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 =65 years) yes F.1.3.1 Number of subjects for this age range 81
Exclusion criteria
Exclusion criteria: - Patients who have received surgery alone or radiotherapy alone as definitive local therapy - Patients with oropharyngeal or oral cavity cancer who have persistent disease at the Primary site post-concurrent CRT or post-RT - 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 the 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 (other than current SCCHN) within 5 years prior to screening, patients who have malignancies of a negligible risk of metastasis or death are eligible - Prior allogeneic stem cell or solid organ transplantation - Current treatment with anti-viral therapy for HBV - Prior neoadjuvant (i.e., induction) treatment or any systemic anti-cancer therapy without definitive local therapy for locally advanced head and neck cancer - Treatment with systemic immunostimulatory agents - Treatment with systemic immunosuppressive - 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 as part of an induction regimen or as part of concurrent therapy with radiotherapy - Any systemic therapy after permitted definitive local therapies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the efficacy of atezolizumab compared with placebo based on investigator assessed event free survival (EFS);Secondary Objective: • To evaluate the efficacy of atezolizumab compared with placebo based on independent review facility (IRF) assessed EFS and overall survival (OS) • To evaluate clinical benefit in atezolizumab compared with placebo in terms of impact on health-related quality of life and physical functioning • To evaluate the safety and tolerability of atezolizumab • To characterize the pharmacokinetics of atezolizumab • To evaluate the incidence and titers of anti-drug antibody(ADA) against atezolizumab;Primary end point(s): 1. Investigator-assessed EFS;Timepoint(s) of evaluation of this end point: 1. Approximately up to 65 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. OS after randomization 2. IRF-assessed EFS 3. 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 over time while receiving treatment 4. Percentage of patients with adverse events 5. Serum concentration of atezolizumab at specified timepoints 6. Incidence of ADA response to atezolizumab;Timepoint(s) of evaluation of this end point: 1. Approximately up to 99 months 2. Approximately up to 65 months 3. Baseline to 3 Months and 6 Months 4. Baseline until up to 90 days after end of treatment (approximately 1 year) 5-6. At pre-defined intervals from Cycle 1, Day 1, through end of treatment (approximately 1 year) | — |
Countries
Australia, Belgium, Brazil, Canada, China, France, Germany, Hungary, India, Italy, Korea, Republic of, Poland, Portugal, Russian Federation, South Africa, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd.
Outcome results
None listed