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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My throat cancer is suspected and can be removed by surgery.
Select...
I am 18 years old or older.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects with a >= 40% increase in the cluster of differentiation 3 (CD3) counts
R0 resection rate
Secondary outcome measures
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 • NCT0200822736%
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%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Peripheral sensory neuropathy
7%
Pain in extremity
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
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
2020
Completed Phase 2
~350
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,088 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active hepatitis B or C.I have severe heart failure (NYHA class III or higher).I have not received a live vaccine recently and do not plan to during the study.I have not had major surgery recently.I am aware of restrictions on certain medications I can take.I have another cancer that is growing or needs treatment.I have an autoimmune disease treated with medication in the last 2 years.I have or had lung inflammation not caused by infection, treated with steroids.I have been diagnosed with stage 2 or higher COPD.I currently have an active Epstein-Barr virus infection.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I am currently taking corticosteroids for my asthma.I am 18 years old or older.I agree to let my biopsy, taken within the last 3 months or a new one, be used for research.My throat cancer is suspected and can be removed by surgery.I agree to use birth control and not donate sperm from the start of the study until 5 months after it ends.My organ functions are within normal ranges as required.I've had targeted therapy or radiation within the last 2 weeks or still have side effects.I am willing to use birth control during and for 5 months after the study.I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks.I have an active TB infection.I am fully active or restricted in physically strenuous activity but can do light work.I have been treated with specific medications before.
Research Study Groups:
This trial has the following groups:- Group 1: Atezolizumab (Adjuvant)
- Group 2: Atezolizumab Monotherapy
- Group 3: Atezolizumab + Tiragolumab
- Group 4: Atezolizumab + Tocilizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the uppermost number of participants enrolled in this research effort?
"Affirmative. Clinicaltrials.gov reveals that this clinical investigation, which was initially listed on March 8th 2019, is currently registering participants. This trial requires 55 patients to be enrolled at 1 medical centre."
Answered by AI
Is this experiment recruiting participants at the moment?
"Affirmative. Clinicaltrials.gov displays that this current trial, which was first posted on March 8th 2019, is actively seeking participants. Enrollment requires 55 patients from a single medical centre to be recruited."
Answered by AI
Could you outline the research that has been conducted concerning Atezolizumab?
"Currently, there are 410 Atezolizumab related clinical trials on record with 78 studies in their third phase. While many of these experiments occur at the Harvey site in Illinois, a total of 19515 medical sites have been involved."
Answered by AI
What conditions is Atezolizumab commonly prescribed for?
"Atezolizumab is commonly used to combat small cell lung cancer, but it also can be employed to treat systemic juvenile idiopathic arthritis (sjia), cytokine release syndrome induced by CAR-T therapy, and a variety of malignant neoplasms."
Answered by AI
Is this research unprecedented in modern times?
"At present, there are 410 active trials related to Atezolizumab in 81 countries and 1798 cities. The inaugural experiment featuring this drug occurred in 2008 courtesy of Hoffmann-La Roche; it saw 720 individuals enter Phase 2 clinical trial approval and concluded successfully. Since that time, 300 more studies have been conducted worldwide."
Answered by AI
Has the FDA approved Atezolizumab for medical use?
"The safety of Atezolizumab has been rated a 2 because this is still in Phase 2; thus, there are some indications that it may be safe but no evidence to support its efficacy."
Answered by AI
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