Preoperative Immunotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlain Algazi
About this trial
To determine the effect of neoadjuvant atezolizumab alone or in combination with other immune modulating agents on T-cell infiltration in advanced SCCHN. To determine the impact of neo-adjuvant immunotherapy on surgical outcomes.
Eligibility criteria
Qualifiers
Patients must have clinically suspected SCCHN that is amenable to surgical resection with therapeutic intent
Be willing and able to provide written informed consent/assent for the trial
Be >=18 years of age on day of signing informed consent.
Agree to research analysis of an existing pre-treatment biopsy available that was obtained within 90 days prior to the day of consent or agree to a new biopsy for research (or clinical diagnosis) within the screening window. Needle biopsies must be at least 20 Gauge in diameter
Disqualifiers
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Participants who have received acute and/or low-dose systemic immunosuppressive medications (e.g., a one-time dose of dexamethasone for nausea or chronic use of <=10 mg/day of prednisone or dose-equivalent corticosteroid) may be enrolled in the study after discussion with and approval by the Sponsor. The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed
Has a known history of active Bacillus tuberculosis (TB).
Has an acute primary infection or reactivation of Epstein-Barr virus (EBV).
Trial design
Treatments tested in this trial
- Atezolizumab
- Tocilizumab
- Tiragolumab
Treatment groups
55 Participants
are divided into 4 treatment groupsSponsors and collaborators
Alain Algazi
Lead sponsor
University of California, San Francisco
Sponsor institution
Genentech, Inc.
Collaborator
American Head and Neck Society
Collaborator
Source ClinicalTrials.gov