Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after cycle 3 (duration of each cycle 21 days)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can provide a sample of my tumor for PD-L1 testing.
Select...
I am fully active or can carry out light work.
Select...
My blood, liver, and kidney functions are good for surgery.
Select...
My blood and organ tests are within safe ranges for surgery.
Select...
My cancer is confirmed as squamous cell carcinoma.
Select...
I am 18 years old or older.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of patients who complete neoadjuvant therapy and surgical resection
Secondary outcome measures
Objective response rate
Pathological response rate
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%
Pain in extremity
7%
Peripheral sensory neuropathy
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
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
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,386 Previous Clinical Trials
17,333,988 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,669 Total Patients Enrolled
Vasu Divi, MDPrincipal InvestigatorStanford Universiy
1 Previous Clinical Trials
14 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any immune-boosting drugs in the last 4 weeks or 5 half-lives of the drug.I have Type 1 diabetes that is managed with insulin.My cancer has spread to distant parts of my body.I am confident in my ability to maintain sexual abstinence as required for the trial's duration.I do not have active tuberculosis.I cannot have surgery as a standard treatment for my condition.I have not received a live vaccine within the last 4 weeks and do not plan to during or within 5 months after treatment.I am taking antibiotics to prevent infections.I can provide a sample of my tumor for PD-L1 testing.My blood thinner medication dose has been stable.I am a woman who can still have children.I have had a stem cell or organ transplant in the past.I don't have any health issues that would make it unsafe for me to take a new drug.I am currently on medication for hepatitis B.I am using a highly effective birth control method.I am fully active or can carry out light work.I am confident in my method of sexual abstinence during the trial.I haven't taken strong immune system medications in the last 2 weeks.My blood and organ tests are within safe ranges for surgery.I have previously been treated with specific immune therapies.I can provide a sample of my tumor for PD-L1 testing.My blood, liver, and kidney functions are good for surgery.I frequently need procedures to remove excess fluid from my body.My thyroid function is controlled, and I am on levothyroxine with no signs of underactive thyroid.My cancer is confirmed as squamous cell carcinoma.I haven't had a severe infection or been hospitalized for one in the last 4 weeks.I have not taken any strong antibiotics in the last 2 weeks.I have never had lung inflammation not caused by infections but can have had lung scarring from radiation.I am 18 years old or older.My thyroid function is controlled, and I am on levothyroxine with no signs of underactive thyroid.I agree to avoid causing pregnancy or donating sperm for 5 months after my last dose.I have a skin condition like eczema or psoriasis, it's well controlled, covers less than 10% of my body, and I haven't needed strong treatments in the last year.I have an autoimmune disease but am only on thyroid-replacement hormone for hypothyroidism.I haven't had major heart issues or strokes in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Atezolizumab
Awards:
This trial has 2 awards, including:- 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.
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.
Is this an innovative clinical trial?
"Atezolizumab's clinical journey began in 2008 when Hoffmann-La Roche sponsored a trial with 720 participants. Due to the success of this Phase 1 research, Atezolizumab was approved for its second stage trials and currently has 351 live studies located across 74 different nations and 1645 cities."
Answered by AI
How many participants have been recruited for this medical experiment?
"Affirmative. The clinicaltrials.gov page informs us that this medical experiment is currently recruiting new participants; the trial was initial posted on June 22nd 2021 and updated most recently on October 24th 2022. They are searching for 20 individuals to join from a single site location."
Answered by AI
What conditions is Atezolizumab typically prescribed to treat?
"Atezolizumab has been proven to be effective in the management of small cell lung cancer (SCLC), malignant neoplasms, and non-small cell lung carcinoma."
Answered by AI
To what degree is Atezolizumab a safe treatment for patients?
"The safety of Atezolizumab has been estimated at a 2, due to the fact that there is evidence for its security but not yet efficacy in this Phase 2 clinical trial."
Answered by AI
Are there any available slots for prospective participants in this experiment?
"Affirmative. According to the information hosted on clinicaltrials.gov, this experiment is actively seeking participants and was first posted on June 22nd 2021. Currently, 20 patients are being sought from a single medical centre for enrollment in the trial."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger