Imvoke10: This phase III trial is evaluating an immunotherapy drug (Atezolizumab) for the treatment of high-risk locally advanced head and neck cancerA 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

Exclusion

• 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