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Preoperative Immunotherapy for Head and Neck Cancers

Phase 2
Recruiting
Led By Alain Algazi, MD
Research Sponsored by Alain Algazi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have clinically suspected SCCHN that is amenable to surgical resection with therapeutic intent
Be >=18 years of age on day of signing informed consent
Must not have
Has known active hepatitis B or hepatitis C
Current New York Heart Association (NYHA) class III or higher heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This trial is testing the effect of a new immunotherapy drug on T-cell infiltration in patients with advanced cancer of the head and neck. The trial will also look at the impact of this immunotherapy on surgical outcomes.

Who is the study for?
Adults with suspected squamous cell carcinoma of the head and neck (SCCHN) that can be surgically removed. They must have good organ function, not be pregnant or breastfeeding, agree to use contraception, and have no recent cancer treatments or severe allergies to trial drugs. Excluded are those with active cancers elsewhere, certain heart conditions, immune diseases requiring treatment in the last 2 years, infections needing hospitalization recently, COPD stage 2+, known HIV without stable treatment or other conditions that may affect trial safety.
What is being tested?
The study is testing if pre-surgery immunotherapy with atezolizumab alone or combined with tocilizumab or tiragolumab can increase T-cell infiltration in SCCHN tumors. It also examines how these treatments affect surgery outcomes. Participants will receive one of these drug combinations before their scheduled surgery.
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in various organs which might mimic symptoms of other diseases; infusion-related reactions; increased risk for infections due to a weakened immune response; potential liver issues; and allergic reactions specific to each drug being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My throat cancer is suspected and can be removed by surgery.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have active hepatitis B or C.
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I have severe heart failure (NYHA class III or higher).
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I have not received a live vaccine recently and do not plan to during the study.
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I have not had major surgery recently.
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I have an autoimmune disease treated with medication in the last 2 years.
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I have or had lung inflammation not caused by infection, treated with steroids.
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I have been diagnosed with stage 2 or higher COPD.
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I currently have an active Epstein-Barr virus infection.
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I am currently taking corticosteroids for my asthma.
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I've had targeted therapy or radiation within the last 2 weeks or still have side effects.
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I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks.
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I have an active TB infection.
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I have been treated with specific medications before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of subjects with a >= 40% increase in the cluster of differentiation 3 (CD3) counts
R0 resection rate
Secondary study objectives
Changes in immune parameters using mass cytometry (CyTOF), histology and gene expression
Changes in peripheral immune responses using CyTOF
Number of participants with treatment-related adverse events

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
36%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Stomatitis
11%
Vomiting
11%
Neuropathy peripheral
10%
Arthralgia
9%
Neutrophil count decreased
9%
Rash
8%
Headache
8%
Dysgeusia
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Abdominal pain
6%
Febrile neutropenia
6%
Lacrimation increased
6%
Dry skin
6%
Pneumonia
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

Trial Design

4Treatment groups
Experimental Treatment
Group I: Atezolizumab MonotherapyExperimental Treatment1 Intervention
Participants will receive 840mg of atezolizumab over 15 days prior to definitive surgery.
Group II: Atezolizumab + TocilizumabExperimental Treatment2 Interventions
Participants will receive 840 mg of atezolizumab IV and 6 mg/kg of Tocilizumab during the 15-day neoadjuvant period prior to definitive surgery.
Group III: Atezolizumab + TiragolumabExperimental Treatment2 Interventions
Participants will receive 840 mg of atezolizumab IV and 600 mg of Tiragolumab during the 15-day neoadjuvant period prior to definitive surgery.
Group IV: Atezolizumab (Adjuvant)Experimental Treatment1 Intervention
Participants will receive 840mg of atezolizumab over 15 days prior to definitive surgery. The first 9 participants in Arm A (atezolizumab monotherapy) will also receive adjuvant atezolizumab 16 weeks after standard of care surgery and radiation, or chemoradiation therapy, at a fixed dose of 1200 mg IV every 3 weeks for an additional 12 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tocilizumab
2012
Completed Phase 4
~1840
Tiragolumab
2019
Completed Phase 3
~1400
Atezolizumab
2017
Completed Phase 3
~5850

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,550 Previous Clinical Trials
568,309 Total Patients Enrolled
Alain AlgaziLead Sponsor
1 Previous Clinical Trials
Alain Algazi, MDPrincipal Investigator - University of California, San Francisco
University Of California (Medical School)
Ucla School Of Medicine (Residency)
1 Previous Clinical Trials
2 Total Patients Enrolled

Media Library

Atezolizumab Clinical Trial Eligibility Overview. Trial Name: NCT03708224 — Phase 2
Head and Neck Cancers Research Study Groups: Atezolizumab (Adjuvant), Atezolizumab Monotherapy, Atezolizumab + Tiragolumab, Atezolizumab + Tocilizumab
Head and Neck Cancers Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03708224 — Phase 2
Atezolizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT03708224 — Phase 2
~18 spots leftby Jun 2027
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