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Locally Advanced Skin Squamous Cell CarcinomaPhase 1NCT05085496

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

A Phase 1 study testing Atezolizumab and Stereotactic Body Radiation Therapy in people with Locally Advanced Skin Squamous Cell Carcinoma and Resectable Skin Squamous Cell Carcinoma, run by City of Hope Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atezolizumab and Stereotactic Body Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
19 Apr 2022to 10 Sep 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  • Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)
  • Women >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up

Who cannot join

  • 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.)
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  • 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
  • Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
  • Any chronic skin condition that does not require systemic therapy
  • Patients without active disease in the last 5 years may be included but only after consultation with the study physician
  • Patients with celiac disease controlled by diet alone
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, idiopathic pulmonary fibrosis, organizing pneumonia, uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently), uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL or corrected serum calcium ULN), uncontrolled tumor-related pain, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent
  • History of another primary malignancy except for:
  • Malignancy treated with curative intent and with no known active disease >= 3 years before the first dose of IP and of low potential risk for recurrence
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Adequately treated carcinoma in situ without evidence of disease
  • History of active primary immunodeficiency
  • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis (TB) testing in line with local practice), hepatitis B (known positive hepatitis B virus [HBV] surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive human immunodeficiency virus [HIV] 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving atezolizumab and up to 5 months after the last dose of atezolizumab
  • Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 5 months after the last dose of atezolizumab monotherapy. Patient must have a negative serum pregnancy test within 72 hours of study entry
  • Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
  • Prior randomization or treatment in a previous atezolizumab clinical study
  • Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • City of Hope Medical Center

    Duarte, California, 91010

    Arya Amini, 626-359-8111, aamini@coh.org

    Arya Amini

    Recruiting

Other trials in United States

About this study

Official title: Phase I Trial of Radiotherapy in Combination With Atezolizumab in Borderline Resectable and Unresectable Cutaneous Squamous Cell Carcinoma(cSCC)

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the safety profile of combination of atezolizumab + radiation therapy (RT) in borderline resectable or unresectable cutaneous squamous cell carcinoma (cSCC).

SECONDARY OBJECTIVES:

  1. Determine pathologic response after neoadjuvant atezolizumab + RT. II. Determine clinical response (via imaging and clinical exam) postoperatively (if surgically resectable) or at post-treatment biopsy (if not surgically resectable), and 3 months following the completion of surgery or RT (if not surgically resectable).

III. Define the toxicity profile associated with the treatment protocol. IV. Assess short-term quality-of-life associated with the treatment protocol.

EXPLORATORY OBJECTIVES:

  1. To compare immune checkpoint molecule (e.g. PD1, PD-L1, TIM3, TIGIT, etc.) expression intensity within tumor cells and immune cells in the tumor microenvironment, as well as immune cell subset infiltration patterns including T cells before and after atezolizumab + stereotactic body radiation therapy (SBRT) by multiplex immunohistochemistry (or immunofluorescence).

II. To evaluate the impact of tumor molecular features on immune response and treatment outcome using next generation targeted deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) sequencing of pre-treatment tumor tissue.

III. To compare changes in circulating immune cell subsets in peripheral blood by RNA-based T-cell receptor (TCR)-sequencing and immunophenotyping by flow cytometry (or immunophenotyping by single-cell RNA sequencing), and correlate changes with response, clinical outcomes, and toxicity.

IV. To evaluate circulating tumor DNA (ctDNA) levels before start of treatment and immediately prior to surgery/repeat biopsy.

OUTLINE:

Patients undergo SBRT on days 1, 3, 5, 7, and 9 of cycle 1. Beginning 1-2 days after SBRT, patients also receive atezolizumab intravenously (IV) on day 1. Treatment repeats every 3 weeks for 3 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study, patients are followed up every 12 weeks for 24 months.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05085496
Study groupRoleWhat they receive
Treatment (SBRT, atezolizumab)ExperimentalPatients 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.
Receives: Biological: Atezolizumab; Radiation: Stereotactic Body Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicity

    Measured: Up to 3 weeks

  2. Incidence of adverse events

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

    Measured: Up to 90 days

Secondary outcomes (3)

  1. 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.

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

  2. Overall survival (OS)

    Will be examined using the Kaplan-Meier method. Median OS and corresponding two-sided 95% confidence intervals will be computed.

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

  3. Progression free survival (PFS)

    Will be examined using the Kaplan-Meier method. Median PFS and corresponding two-sided 95% confidence intervals will be computed.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2021
  2. Study start19 Apr 2022
  3. Primary completion10 Sep 2027 (estimated)
  4. Study completion10 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05085496
Sponsor's protocol ID
21285
Other IDs
NCI-2021-09849, 21285, P30CA033572
Status last verified
Jan 2026
First submitted
7 Oct 2021
Last updated
28 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Atezolizumab and Stereotactic Body Radiation Therapy in people with Locally Advanced Skin Squamous Cell Carcinoma and Resectable Skin Squamous Cell Carcinoma, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (time frame: Up to 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05085496.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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