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Checkpoint Inhibitor

Radiotherapy + Atezolizumab for Squamous Cell Carcinoma

Phase 1

Recruiting

Led By Arya Amini

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Age >= 18 years at time of study entry

For patients receiving therapeutic anticoagulation: stable anticoagulant regimen

Must not have

History of another primary malignancy

Active or prior documented autoimmune or inflammatory disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of diagnosis to the date of death, assessed up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety of using a combination of radiotherapy and atezolizumab to treat patients with squamous cell cancer that has spread locally and is either resectable or unresectable.

Who is the study for?

Adults with advanced cutaneous squamous cell carcinoma (cSCC) that is borderline resectable or unresectable, and possibly with a few sites of metastasis. Participants must have measurable disease, adequate organ function, no severe allergies to monoclonal antibodies like atezolizumab, not be on certain medications including immunosuppressants recently, and women must not be pregnant or breastfeeding.

What is being tested?

The trial is testing the combination of radiotherapy with an immunotherapy drug called Atezolizumab in patients with locally advanced cSCC. The goal is to see if this combo can better control cancer than when each treatment is used alone.

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal organs (like inflammation), fatigue, skin reactions from radiation therapy, potential liver enzyme changes due to Atezolizumab, and typical risks associated with radiation such as localized skin damage.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My blood thinner medication dose has been stable.

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My skin cancer is advanced but cannot be removed with surgery.

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I am fully active and can carry on all pre-disease activities without restriction.

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I am post-menopausal or have a negative pregnancy test if pre-menopausal.

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My cancer can be measured and is larger than 10 mm according to scans or exams.

Exclusion Criteria

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

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I have had another type of cancer.

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I have or had an autoimmune or inflammatory disorder.

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I haven't taken any immune-boosting drugs in the last 4 weeks or 5 half-lives of the drug.

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I am not on any cancer treatments not recommended by NCCN for my head and neck cancer.

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I have had an organ or bone marrow transplant from a donor.

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I do not have any unmanaged ongoing illnesses.

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I have previously been treated with medications targeting the immune system.

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I do not have active infections like TB, hepatitis B, hepatitis C, or HIV.

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I have or had lung inflammation that needed steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of diagnosis to the date of death, assessed up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of diagnosis to the date of death, assessed up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of diagnosis to the date of death, assessed up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events

Secondary study objectives

Overall survival (OS)

Progression free survival (PFS)

Treatment response rate

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446

87%

Fatigue

53%

Nausea

33%

Cough

27%

Pain

27%

Fall

27%

Dyspnea

27%

Depression

27%

Lymphocyte count decreased

27%

Platelet count decreased

27%

Anemia

20%

Chills

20%

Dizziness

20%

Chest pain

20%

Neutropenia

20%

Diarrhea

20%

Edema limbs

13%

Dysesthesia

13%

Insomnia

13%

Edema

13%

Constipation

13%

Delirium

13%

Dysgeusia

13%

Skin infection

13%

Vomiting

13%

Tinnitus

13%

Rash

13%

Myalgia

13%

Back pain

13%

Weakness (limb)

13%

Weight loss

Proteinuria

Anxiety

Hearing loss

Oral lesions

Acute kidney injury

Hypokalemia

Lymphocytopenia

Seizures

Weakness (facial)

Anorexia

Neutrophil count decreased

Bruising

Hearing impaired

Death NOS

Hypertension

Headache

Creatinine increased

Pleural effusion

Gait disturbance

Nasal congestion

Tremor

Urinary urgency

Amnesia

Hypernatremia

Photophobia

Urinary frequency

Dysphagia

Low white blood count

Sneezing

Cognitive disturbance

Erythema multitforme

Lung infection

Allergy (seasonal)

Muscle weakness

Hypomagnesemia

Parathesia (tingling)

Febrile Neutropenia

Hypoxic respiratory failure

Headaches

Fever

Sleep apnea

Encephalopathy

Hypoxia

Shingles

100%

80%

60%

40%

20%

Study treatment Arm

Maintenance Chemotherapy

Stereotactic Body Radiation Therapy

Awards & Highlights

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: Treatment (SBRT, atezolizumab)Experimental Treatment2 Interventions

Patients undergo SBRT on days 1, 3, 5, 7, and 9 of cycle 1. Beginning 1-2 days after SBRT, patients also receive atezolizumab IV on day 1. Treatment repeats every 3 weeks for 3 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~790