Atezolizumab Before Surgery for the Treatment of Regionally Metastatic Head and Neck Squamous Cell Cancer With an Unknown or Historic Primary Site

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT05110781
Phase
PHASE2
Status
Terminated

Conditions

  • Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck
  • Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck
  • Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — BIOLOGICAL
    Given IV
  • Radiation Therapy — RADIATION
    Undergo radiation therapy
  • Therapeutic Conventional Surgery — PROCEDURE
    Undergo surgery

Study Details

This phase II trial tests whether atezolizumab works to shrink tumors before surgery in patients with head and neck squamous cell cancer with an unknown or historic primary site that has spread to other places in the lymph nodes (regionally metastatic). 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 atezolizumab before surgery may reduce the size of the tumor.

Key Dates

Start date
Dec 7, 2021
Status verified
May 2026
Primary completion
May 2, 2022
Completion
Apr 18, 2023

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (atezolizumab, surgery, radiation therapy)
    Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery. Beginning 6 weeks after surgery, patients with residual disease undergo standard of care radiation therapy and receive atezolizumab IV over 30-60 minutes on day 1. Treatment with atezolizumab repeats every 21 days for up to 15 cycles in the absence of disease progression and unacceptable toxicity.

Primary Outcome Measure

Pathologic Complete Response (pCR) [ Time Frame: At time of surgery (up to 10 weeks from time of enrollment) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-

Find similar trials in Sacramento, CA

By research site
University of California Davis Comprehensive Cancer Center· Sacramento, CA

Related Studies