Dynamic CD8+ T cell responses to cancer immunotherapy in human regional lymph nodes are disrupted in metastatic lymph nodes.
Maha K Rahim, Trine Line H Okholm, Kyle B Jones...
https://pubmed.ncbi.nlm.nih.gov/36931243Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID03708224
Preoperative Immunotherapy with Atezolizumab Alone or Combined with Tiragolumab or Tocilizumab in Patients with Advanced 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
Researchers are evaluating the effects of neoadjuvant immunotherapy using atezolizumab alone or combined with other immune-modulating agents in patients with advanced squamous cell carcinoma of the head and neck (SCCHN). The study aims to understand how these treatments influence T-cell infiltration in tumors and their impact on surgical outcomes. It also explores changes in immune responses and safety profiles during the perioperative period, along with examining the gut microbiome and certain blood markers related to disease status. This is a phase II, open-label, multi-arm trial focusing on advanced SCCHN treatment combinations involving atezolizumab. Participants receive preoperative treatments in different groups: Arm A gets two intravenous infusions of atezolizumab before surgery and radiation, with some receiving additional adjuvant atezolizumab after surgery. Arm B involves atezolizumab combined with tiragolumab infusions before surgery. Arm C participants receive atezolizumab combined with tocilizumab, with tocilizumab given intravenously first, followed by atezolizumab two hours later. New treatment combinations may be explored sequentially based on initial results, and all treatments are given within up to 15 days before surgery. During the study, participants are monitored with follow-up visits at 30 days post-surgery, then at 3, 6, 12, and 24 months. Researchers assess immune cell changes, surgical outcomes including the rate of complete tumor removal, relapse-free survival over two years, and safety of the treatments. Blood tests and biopsies are performed to analyze immune responses and other markers. The overall participation period extends up to two years, allowing detailed evaluation of long-term effects and treatment safety.
CONDITIONS
Official Title
Preoperative Immunotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck
Who Can Participate
Age: 18Years +
All Genders
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
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1
2
3
Trial Site Locations
Total: 1 location
1
University of San Francisco, California
San Francisco, California, United States, 94143
Actively Recruiting
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Research Team
U
UCSF HDFCCC Cancer Immunotherapy Program (CIP)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Frequently Asked Questions
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