Radiotherapy + Atezolizumab for Squamous Cell Carcinoma

Recruiting in Palo Alto (17 mi)

Overseen by Arya Amini

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: City of Hope Medical Center

Must not be taking: Immunosuppressants, PD1 inhibitors

Disqualifiers: Interstitial lung disease, Autoimmune disorders, Active infection, others

No Placebo Group

Breakthrough Therapy

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 3 5 6 7}

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. ^{1 2 3 5 8}

Research Team

Arya Amini

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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

Absolute neutrophil count (ANC) >= 1.0 x 10^9/L

I am 18 years old or older.

Platelet count >= 75 x 10^9/L

Exclusion Criteria

Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation

I have had another type of cancer.

I have or had an autoimmune or inflammatory disorder.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy

Patients undergo stereotactic body radiation therapy (SBRT) on days 1, 3, 5, 7, and 9 of cycle 1

1 week

5 visits (in-person)

Treatment

Patients receive atezolizumab intravenously (IV) beginning 1-2 days after SBRT, repeating every 3 weeks for 3 cycles

9 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Every 12 weeks

Treatment Details

Interventions

• Atezolizumab (Checkpoint Inhibitor)
• Stereotactic Body Radiation Therapy (Radiation)

Trial Overview The trial is testing the combination of radiotherapy with an immunotherapy drug called Atezolizumab in patients with locally advanced cSCC. The goal is to see if this combo can better control cancer than when each treatment is used alone.

Participant Groups

Group I: Treatment (SBRT, atezolizumab) Experimental Treatment 2 Interventions

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.

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

🇪🇺 Approved in European Union as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

City of Hope Medical Center Duarte, CA

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Patients Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14080

Patients Recruited

41,180,000+

Genentech, Inc.

Industry Sponsor

Trials

1578

Patients Recruited

569,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab plus stereotactic ablative radiotherapy for medically inoperable patients with early-stage non-small cell lung cancer: a multi-institutional phase I trial. Monjazeb, AM., Daly, ME., Luxardi, G., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. Markham, A.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. Inman, BA., Longo, TA., Ramalingam, S., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: A novel PD-L1 inhibitor in cancer therapy with a focus in bladder and non-small cell lung cancers. Krishnamurthy, A., Jimeno, A.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: A Review in Extensive-Stage SCLC. Frampton, JE.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. Hayashi, K., Suzuki, O., Shiomi, H., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab as the First Systemic Therapy Approved for Alveolar Soft Part Sarcoma. Bergsma, EJ., Elgawly, M., Mancuso, D., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Bladder Preservation Therapy in Combination with Atezolizumab and Radiation Therapy (BPT-ART) for Invasive Bladder Cancer: Interim Analysis from a Multicenter, Open-label, Prospective Phase 2 Trial. Kimura, T., Ishikawa, H., Nagumo, Y., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Atezolizumab plus stereotactic ablative radiotherapy for medically inoperable patients with early-stage non-small cell lung cancer: a multi-institutional phase I trial. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. [2022]

4. Spain pubmed.ncbi.nlm.nih.gov

Atezolizumab: A novel PD-L1 inhibitor in cancer therapy with a focus in bladder and non-small cell lung cancers. [2019]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Atezolizumab: A Review in Extensive-Stage SCLC. [2021]

6. Greece pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Atezolizumab as the First Systemic Therapy Approved for Alveolar Soft Part Sarcoma. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Bladder Preservation Therapy in Combination with Atezolizumab and Radiation Therapy (BPT-ART) for Invasive Bladder Cancer: Interim Analysis from a Multicenter, Open-label, Prospective Phase 2 Trial. [2023]