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Neoadjuvant Atezolizumab for Squamous Cell Carcinoma

Phase 2

Waitlist Available

Led By Vasu Divi, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Availability of a representative tumor specimen that is suitable for determination of PD-L1 immunohistochemical stain evaluation

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Must not have

Distant metastatic disease

Active tuberculosis. Patents do NOT have to be screened for tuberculosis for this trial.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after cycle 3 (duration of each cycle 21 days)

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will test whether the immunotherapy drug atezolizumab can help treat patients with mesothelioma by reducing the size of their tumors before surgery.

Who is the study for?

Adults with confirmed advanced cutaneous squamous cell carcinoma that can be surgically removed may join this trial. They should have measurable disease, acceptable organ function for surgery, and no history of certain autoimmune diseases or immune deficiencies. Women who can bear children and men must agree to use effective contraception.

What is being tested?

The trial is testing the safety and effectiveness of Atezolizumab given before surgical removal of the tumor in patients with advanced skin cancer. It aims to see if pre-surgery treatment improves outcomes.

What are the potential side effects?

Atezolizumab might cause immune-related reactions affecting different organs, infusion-related symptoms, fatigue, possible liver enzyme changes, and could increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can provide a sample of my tumor for PD-L1 testing.

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I am fully active or can carry out light work.

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My blood, liver, and kidney functions are good for surgery.

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My blood and organ tests are within safe ranges for surgery.

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My cancer is confirmed as squamous cell carcinoma.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to distant parts of my body.

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I do not have active tuberculosis.

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I cannot have surgery as a standard treatment for my condition.

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I have not received a live vaccine within the last 4 weeks and do not plan to during or within 5 months after treatment.

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I have had a stem cell or organ transplant in the past.

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I have previously been treated with specific immune therapies.

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I am currently on medication for hepatitis B.

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I frequently need procedures to remove excess fluid from my body.

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I haven't had a severe infection or been hospitalized for one in the last 4 weeks.

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I haven't had major heart issues or strokes in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after cycle 3 (duration of each cycle 21 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after cycle 3 (duration of each cycle 21 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and after cycle 3 (duration of each cycle 21 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of patients who complete neoadjuvant therapy and surgical resection

Secondary study objectives

Objective response rate

Pathological response rate

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: AtezolizumabExperimental Treatment1 Intervention

Subjects will receive neoadjuvant atezolizumab intravenous (IV) infusion at a fixed dose of 1200 mg on Day 1 (+/- 3 days) of each 21-day cycle for a total of 3 doses prior to surgery, unless there is clinical or radiographic evidence of disease progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

FDA approved

0 / 16Eligibility criteria met