Radiotherapy + Atezolizumab for Squamous Cell Carcinoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase I trial tests the safety and side effects radiotherapy in combination with atezolizumab in treating patients with cutaneous squamous cell cancer that has spread to nearby tissue or lymph nodes (locally advanced) and can be removed from surgery (resectable) or cannot be remove by surgery (unresectable). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving radiotherapy in combination with atezolizumab may help improve outcomes for remission (cancer that is under control) than taking either treatment separately.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that patients should not have received certain treatments like systemic immunostimulatory agents or immunosuppressive medication shortly before starting the trial. It's best to discuss your specific medications with the study team.
Is the combination of radiotherapy and atezolizumab safe for humans?
The combination of atezolizumab and stereotactic ablative radiotherapy (SABR) has been studied in patients with early-stage non-small cell lung cancer and was found to be well tolerated, with the full dose of atezolizumab being safe. Atezolizumab alone has been used safely in various cancers, including small cell lung cancer and bladder cancer, with common side effects like rash and hypothyroidism, but no new safety concerns were identified when combined with other treatments.12345
How is the treatment of radiotherapy plus atezolizumab unique for squamous cell carcinoma?
This treatment combines atezolizumab, an immune checkpoint inhibitor that boosts the body's immune response against cancer, with stereotactic body radiation therapy (SABR), which precisely targets tumors with high doses of radiation. This combination aims to enhance the effectiveness of treatment by using the body's immune system alongside targeted radiation, which is a novel approach compared to traditional treatments.23567
What data supports the effectiveness of the drug Atezolizumab for treating squamous cell carcinoma?
Atezolizumab has shown effectiveness in treating other cancers like bladder cancer and non-small cell lung cancer by enhancing the immune system's ability to fight tumors, with significant improvements in response rates and survival. Additionally, combining Atezolizumab with stereotactic ablative radiotherapy (SABR) has shown early positive responses in lung cancer patients, suggesting potential benefits for other cancers.23568
Who Is on the Research Team?
Arya Amini
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiotherapy
Patients undergo stereotactic body radiation therapy (SBRT) on days 1, 3, 5, 7, and 9 of cycle 1
Treatment
Patients receive atezolizumab intravenously (IV) beginning 1-2 days after SBRT, repeating every 3 weeks for 3 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Atezolizumab
- Stereotactic Body Radiation Therapy
Atezolizumab is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD