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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Neutrophil count decreased

Rash

Headache

Dysgeusia

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1810