Actively Recruiting
Preoperative Immunotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck
Led by Alain Algazi · Updated on 2025-01-28
55
Participants Needed
1
Research Sites
486 weeks
Total Duration
On this page
Sponsors
A
Alain Algazi
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Preoperative Immunotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have clinically suspected squamous cell carcinoma of the head and neck (SCCHN) suitable for surgical removal
- Willing and able to provide written informed consent or assent
- Age 18 years or older at the time of consent
- Agree to provide a pre-treatment biopsy taken within 90 days before consent or agree to a new biopsy during screening
- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Adequate organ function based on specific blood count and chemistry levels within 14 days before treatment
- Negative pregnancy test within 7 days before first dose for females of childbearing potential
- Females of childbearing potential must agree to use effective contraception during the study and for 5 months after last dose
- Males must agree to use effective contraception and avoid sperm donation during the study and for 5 months after last dose
You will not qualify if you...
- Participation in another investigational treatment study or use of investigational device within 4 weeks before first treatment dose
- Diagnosis of immunodeficiency or use of systemic immunosuppressive therapy within 7 days before first dose, with some exceptions
- History of active tuberculosis or acute/reactivated Epstein-Barr virus infection
- Known allergy or hypersensitivity to study drugs or their components
- Recent use of anticancer monoclonal antibodies, targeted therapies, or radiation therapy within specified timeframes
- Presence of other progressing malignancies requiring treatment, with some exceptions
- Active autoimmune disease needing systemic treatment in past 2 years
- History or evidence of pneumonitis requiring corticosteroids
- Stage 2 or higher chronic obstructive pulmonary disease (COPD) or asthma requiring systemic corticosteroids
- Medical, psychiatric, or substance abuse conditions interfering with study participation
- Pregnant or breastfeeding women, or those planning conception during study
- Prior therapy with certain immune checkpoint inhibitors
- Active hepatitis B or C infection, or certain heart failure classifications
- Recent live attenuated vaccine use or anticipated need during study
- HIV positive patients must meet specific stability criteria
- Recent major surgery or planned major surgery within 6 months after treatment
- Prior use of cell-depleting therapies or treatments causing severe allergic reactions
- Serious uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal diseases
- Recent serious infections requiring hospitalization or intravenous antibiotics
- Lack of peripheral venous access
- Additional restrictions apply for arms involving tiragolumab or tocilizumab, including allergy history, active infections, CNS disorders, gastrointestinal conditions, and liver disease
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of San Francisco, California
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
U
UCSF HDFCCC Cancer Immunotherapy Program (CIP)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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