Actively Recruiting
Radiotherapy in Combination With Atezolizumab in Locally Advanced Borderline Resectable or Unresectable Cutaneous SCC
Led by City of Hope Medical Center · Updated on 2026-01-28
12
Participants Needed
1
Research Sites
281 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Radiotherapy in Combination With Atezolizumab in Locally Advanced Borderline Resectable or Unresectable Cutaneous SCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced borderline resectable or unresectable cutaneous squamous cell carcinoma (cSCC) or oligometastatic cSCC with 1-3 metastatic sites receiving therapy to the primary tumor
- Measurable disease with lesions larger than 10 mm by CT scan or clinical exam according to RECIST 1.1 criteria
- Written informed consent and any required local authorization obtained before any study procedures
- Age 18 years or older at study entry
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy of at least 24 weeks
- Body weight greater than 30 kg
- Hemoglobin level of 9.0 g/dL or higher
- Absolute neutrophil count (ANC) of at least 1.0 x 10^9/L
- Platelet count of at least 75 x 10^9/L
- Serum bilirubin less than or equal to 1.5 times the institutional upper limit of normal (ULN), except for patients with confirmed Gilbert's syndrome
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels less than or equal to 2.5 times ULN
- Serum albumin at least 25 g/L (2.5 g/dL)
- Creatinine clearance greater than 40 mL/min measured or calculated
- Stable anticoagulant regimen if receiving therapeutic anticoagulation
- Females must be post-menopausal or have a negative pregnancy test if pre-menopausal, with specific age and hormonal status criteria
- Willingness and ability to comply with study treatment and scheduled visits, including follow-up
You will not qualify if you...
- Participation in another clinical trial with an investigational product within the last 3 months
- Active interstitial lung disease (ILD) or pneumonitis or history of these conditions requiring steroids
- Concurrent enrollment in another interventional clinical study, except observational or follow-up studies
- Previous treatment with PD-1 or PD-L1 inhibitors or related immune checkpoint therapies
- Use of systemic immunostimulatory agents within 4 weeks or 5 half-lives before study treatment
- Recent anticancer therapy within 30 days or longer depending on prior treatment type
- Corrected QT interval (QTc) greater than 470 msec
- Use of immunosuppressive medication within 14 days before first dose of atezolizumab, with some steroid exceptions
- Concurrent chemotherapy or investigational therapy not part of standard care
- History of allogenic organ or bone marrow transplant
- Active or prior autoimmune or inflammatory disorders, with some exceptions
- Uncontrolled illnesses or infections including tuberculosis, hepatitis B or C, or HIV
- Receipt of live attenuated vaccine within 30 days before study
- Pregnancy, breastfeeding, or unwillingness to use effective birth control
- Known hypersensitivity to atezolizumab components or severe allergic reactions to similar antibodies
- Prior participation in an atezolizumab clinical trial
- Investigator judgment deeming patient unsuitable for study participation or unlikely to comply with requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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