Clareo Health | A 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
A 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
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Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
