Radiotherapy in Combination With Atezolizumab in Locally Advanced Borderline Resectable or Unresectable Cutaneous SCC

NCT05085496 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: 21285NCI-2021-09849P30CA033572
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Locally Advanced Skin Squamous Cell Carcinoma; Resectable Skin Squamous Cell Carcinoma; Unresectable Skin Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicity

  Up to 3 weeks

• Incidence of adverse events

  Toxicity will be assessed by Common Terminology Criteria for Adverse Events version 5 criteria.

  Up to 90 days

Secondary Outcomes (3)

• Treatment response rate

  After completion of cycle 3 (each cycle is 21 days)

• Overall survival (OS)

  From the date of diagnosis to the date of death, assessed up to 24 months

• Progression free survival (PFS)

  From the date of diagnosis to the date of progression, assessed up to 24 months

Study Arms (1)

Treatment (SBRT, atezolizumab)

EXPERIMENTAL

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.

Biological: Atezolizumab; Radiation: Stereotactic Body Radiation Therapy

Interventions

Atezolizumab BIOLOGICAL

Given IV

Also known as: MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A, MPDL328OA, RG7446, RO5541267, Tecentriq

Treatment (SBRT, atezolizumab)

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Treatment (SBRT, atezolizumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
• Life expectancy \>= 24 weeks
• Body weight \> 30 kg
• Hemoglobin \>= 9.0 g/dL
• Absolute neutrophil count (ANC) \>= 1.0 x 10\^9/L (\>= 1000 per mm\^3)
• Platelet count \>= 75 x 10\^9/L (\>= 75,000 per mm\^3)
• Serum bilirubin =\< 1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal
• Serum albumin 25 g/L (2.5 g/dL)
• Measured creatinine clearance (CL) \> 40 mL/min or calculated creatinine CL\>40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
• For patients receiving therapeutic anticoagulation: stable anticoagulant regimen

You may not qualify if:

• 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)
• Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \[IL-2\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
• Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 30 days prior to the first dose of study drug for patients who have received prior tyrosine kinase inhibitors (TKIs) \[e.g., erlotinib, gefitinib and crizotinib\] and within 6 weeks for nitrosourea or mitomycin C. (If sufficient wash-out time has not occurred due to the schedule or pharmacokinetics (PK) properties of an agent, a longer wash-out period may be required.)
• Patients with corrected QT (QTc) interval \> 470 msec during screening
• Current or prior use of immunosuppressive medication within 14 days (use 28 days if combining atezolizumab with a novel agent) before the first dose of atezolizumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. The following are exceptions to this criterion:
• Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
• Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
• Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
• Any concurrent chemotherapy, investigational product (IP), biologic, or hormonal therapy that is not part of standard National Comprehensive Cancer Network (NCCN) indicated head and neck squamous cell carcinoma (HNSCC) adjuvant concurrent chemoradiotherapy (CRT). Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable
• History of allogenic organ or bone marrow transplantation
• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:
• Patients with vitiligo or alopecia

Sponsors & Collaborators

• City of Hope Medical Center: lead
• Genentech, Inc.: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Interventions

atezolizumab; Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Arya Amini

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 20, 2021
• Study Start: April 19, 2022
• Primary Completion (Estimated): September 10, 2027
• Study Completion (Estimated): September 10, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

US (1)