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.
Histologically or cytologically confirmed locally advanced borderline resectable or unresectable cSCC and oligometastatic (1-3 sites of metastatic disease) cSCC receiving therapy to the primary
Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 10 mm with computed tomography (CT) scan or > 10 mm with calipers by clinical exam by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] Data Privacy Directive in the EU) obtained from the patient prior to performing any protocol-related procedures, including screening evaluations
Age >= 18 years at time of study entry
Participation in another clinical study with an investigational product during the last 3 months
Patients with active interstitial lung disease (ILD)/pneumonitis or with a history of ILD/pneumonitis requiring steroids
Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
Any previous treatment with a PD1 or PD-L1 inhibitor, including atezolizumab, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Single group
Atezolizumab
Biological/VaccineGiven IV
Stereotactic Body Radiation Therapy
RadiationUndergo SBRT
Dose limiting toxicity
Incidence of adverse events
Toxicity will be assessed by Common Terminology Criteria for Adverse Events version 5 criteria.
Treatment response rate
Will be calculated as the ratio of the number of patients who demonstrated a complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) divided by the number of patients evaluable for response.
Overall survival (OS)
Will be examined using the Kaplan-Meier method. Median OS and corresponding two-sided 95% confidence intervals will be computed.
Progression free survival (PFS)
Will be examined using the Kaplan-Meier method. Median PFS and corresponding two-sided 95% confidence intervals will be computed.
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City of Hope Medical Center
Lead sponsor
Genentech, Inc.
Collaborator
National Cancer Institute (NCI)
Collaborator
