Radiotherapy + Atezolizumab for Head and Neck Cancer

Recruiting at 3 trial locations

Overseen By Tessa McSpadden

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Colorado, Denver

Must not be taking: Immunosuppressants, PD-1/PD-L1 inhibitors

Disqualifiers: Active infection, Autoimmune disease, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

11 Participants Needed

Trial Summary

What is the purpose of this trial?

To determine the outcomes of patients with specific head and neck cancer after undergoing radiation therapy with atezolizumab followed by surgery then radiation with or without chemotherapy according to national guidelines.

Research Team

Sana Karam, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

Adults over 18 with certain advanced head and neck cancers (excluding HPV-related types) who can undergo radiation, atezolizumab treatment, and surgery. They must be in good health otherwise, not have had recent major surgeries or severe infections, and cannot be on immunosuppressive drugs or have a history of significant other diseases.

Inclusion Criteria

My blood thinner medication dose has been stable.

Provision to sign and date the consent form

Hemoglobin ≥9.0 g/dL

Exclusion Criteria

Patients with QTc interval > 470 msec during screening

I have not had a severe infection or been hospitalized for one in the last 4 weeks.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy with Neoadjuvant Atezolizumab

Participants receive neoadjuvant atezolizumab with 3 fractions of SBRT

3 weeks

3 visits (in-person)

Surgical Resection

Participants undergo surgical resection following radiotherapy and atezolizumab

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

• Atezolizumab
• Stereotactic Body Radiation Therapy

Trial Overview The trial is testing the effectiveness of combining radiotherapy with atezolizumab before surgical removal of the cancer. It aims to see how well patients do after this combined treatment followed by standard post-surgery care which may include chemotherapy.

Participant Groups

Group I: SBRT with Neoadjuvant Atezolizumab Experimental Treatment 2 Interventions

After the MTD is determined, additional patients will be enrolled at this dose level to ensure 14 patients evaluable for the efficacy endpoints (MPR) at the planned interim analysis. The 6 patients treated at the MTD in phase I will be included if evaluable for MPR, so that additional 8 patients will be enrolled in this stage.

Group II: Phase 1 Lead-in SBRT with Neoadjuvant Atezolizumab Experimental Treatment 2 Interventions

Initially 3 patients will be enrolled to receive one dose of neoadjuvant atezolizumab with 3 fractions of 8 Gy SBRT (dose level 2, i.e. starting dose). If there are \< = 1 DLT related to the neoadjuvant therapy, another 3 patients will be enrolled at the same SBRT dose with only one cycle of neoadjuvant atezolizumab. And if there are \<= 1 DLT out of the 6 patients, then determine MTD at this dose level.

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

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD