Radiotherapy + Atezolizumab for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen bySana Karam, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Colorado, Denver

No Placebo Group

Breakthrough Therapy

Approved in 2 Jurisdictions

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

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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

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Treatment Details

Interventions

Atezolizumab (Monoclonal Antibodies)
Stereotactic Body Radiation Therapy (Radiation)

Trial OverviewThe 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

2Treatment groups

Experimental Treatment

Group I: SBRT with Neoadjuvant AtezolizumabExperimental Treatment2 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 AtezolizumabExperimental Treatment2 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.