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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicity
Incidence of adverse events
Secondary outcome measures
Overall survival (OS)
Progression free survival (PFS)
Treatment response rate
Side effects data
From 2022 Phase 2 trial • 29 Patients • NCT0204544679%
Cough
64%
Dyspnea
64%
Nausea
57%
Fatigue
43%
Constipation
36%
Pain
36%
Dizziness
29%
Anemia
29%
Back pain
29%
Vomiting
21%
Chest pain
21%
Anorexia
21%
Lymphocyte count decreased
21%
Death NOS
21%
Anxiety
21%
Fall
14%
Wheezing
14%
Dysphagia
14%
Hypotension
14%
Depression
14%
Diarrhea
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
7%
Alopecia
7%
Dehydration
7%
Blurred vision
7%
Sinusitis
7%
Dysgeusia
7%
Hemorrhoids
7%
Amnesia
7%
Confusion
7%
Otitis externa
7%
Creatinine increased
7%
Dementia
7%
Productive cough
7%
Pneumonitis
7%
Dysuria
7%
White blood cell count decreased
7%
Throat pain
7%
Bone marrow biopsy
7%
Hearing impaired
7%
Rash
7%
Hypernatremia
7%
Eye pain
7%
Hypertension
7%
Tachycardia
7%
Lung infection
7%
Neuropathy
7%
Pleuritic pain
7%
Neutropenia
7%
Hypoxia
7%
Aspiration pneumonia
7%
Blood bilirubin increased
7%
Muscle weakness
7%
Tremor
7%
Weight loss
7%
Thrombocytopenia
7%
Floaters
7%
Toothache
7%
Esophagitis
7%
Leukocytosis
7%
Edema limbs
7%
Gait disturbance
7%
Parathesia (tingling)
7%
Edema face
7%
COPD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy
Maintenance Chemotherapy
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
2017
Completed Phase 3
~5860
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,669 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,887 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,448 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had another type of cancer.I have or had an autoimmune or inflammatory disorder.I haven't taken any immune-boosting drugs in the last 4 weeks or 5 half-lives of the drug.I am not on any cancer treatments not recommended by NCCN for my head and neck cancer.I am 18 years old or older.I am willing and able to follow the study's treatment plan and attend all visits.I have had an organ or bone marrow transplant from a donor.I do not have any unmanaged ongoing illnesses.I have not received a live vaccine in the last 30 days.My blood thinner medication dose has been stable.I have previously been treated with medications targeting the immune system.I haven't taken immunosuppressive drugs in the last 14 days.My skin cancer is advanced but cannot be removed with surgery.I am fully active and can carry on all pre-disease activities without restriction.I do not have active infections like TB, hepatitis B, hepatitis C, or HIV.I have or had lung inflammation that needed steroids.I am post-menopausal or have a negative pregnancy test if pre-menopausal.I received my last cancer treatment at least 30 days ago, or 6 weeks ago if it was nitrosourea or mitomycin C.I am not pregnant or breastfeeding and willing to use effective birth control during and for 5 months after treatment.My cancer can be measured and is larger than 10 mm according to scans or exams.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (SBRT, atezolizumab)
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 diseases has Stereotactic Body Radiation Therapy been applied to historically?
"Stereotactic Body Radiation Therapy is an effective treatment option for small cell lung cancer (SCLC), malignant neoplasms, and non-small cell lung carcinoma."
Answered by AI
Is this investigation an unprecedented event in the field of medicine?
"The journey of Stereotactic Body Radiation Therapy began in 2008, when Hoffmann-La Roche sponsored its initial study with 720 participants. Subsequent Phase 2 drug approval led to 350 active trials around the globe located in 74 different countries and 1646 cities."
Answered by AI
Is the enrollment phase of this research project still open?
"Absolutely. According to information on clinicaltrials.gov, this medical trial is open for enrolment and has been since April 19th 2022. The latest edits were made August 2nd 20202 and the study requires 12 participants from a single site."
Answered by AI
Has the FDA sanctioned Stereotactic Body Radiation Therapy as a viable treatment option?
"There is limited evidence backing up the safety and efficacy of Stereotactic Body Radiation Therapy, so it earned a score of 1."
Answered by AI
How many individuals have been enlisted in the research endeavor?
"Affirmative. The information available on clinicaltrials.gov confirms that this investigation is currently recruiting volunteers, which was first advertised on April 19th 2022 and had its most recent update happen in August 2nd of the same year. The study requires 12 individuals to be gathered from one medical facility."
Answered by AI
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