A Phase II Study of Preoperative Immunotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck
Alain Algazi
Summary
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.
Description
PRIMARY OBJECTIVES: I. To determine the effect of neoadjuvant atezolizumab alone or in combination with tiragolumab, tocilizumab, or other immune modulating agent(s) on T-cell infiltration in advanced in advanced squamous cell carcinoma of the head and neck (SCCHN). (Translational). II. To determine the impact of neo-adjuvant immunotherapy on surgical outcomes. (Clinical). SECONDARY OBJECTIVES: I. To describe the changes in T-cell subtypes and other mediators of antitumor immune response induced by neoadjuvant atezolizumab alone or in combination with tiragolumab, tocilizumab, or other imm…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients must have clinically suspected SCCHN that is amenable to surgical resection with therapeutic intent 2. Be willing and able to provide written informed consent/assent for the trial 3. Be \>=18 years of age on day of signing informed consent. 4. 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 5. Have a performance status of 0 or 1 on th…
Interventions
- BiologicalAtezolizumab
Given intravenously (IV)
- BiologicalTocilizumab
Given IV
- BiologicalTiragolumab
Given IV
Location
- University of San Francisco, CaliforniaSan Francisco, California