Radiotherapy in Combination With Atezolizumab Prior to Surgical Resection for HPV Unrelated HNSCC

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05053737
Phase
PHASE1
Status
Completed

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    One cycle of Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg. Atezolizumab should be administered within 7 days after initiation of of the first dose of SBRT.
  • Stereotactic Body Radiation Therapy — RADIATION
    SBRT will be given 3 times on non-consecutive days over the course of 5 to 7 days. Radiation will target sites of gross disease only to minimized exposure to normal tissue.

Study Details

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.

Key Dates

Start date
Nov 2, 2021
Status verified
Jan 2025
Primary completion
Nov 24, 2023
Completion
Jun 21, 2024

Study Design

Enrollment
11 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Lead-in SBRT with Neoadjuvant Atezolizumab
    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.
  • Experimental: SBRT with Neoadjuvant Atezolizumab
    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.

Primary Outcome Measure

Phase I lead in: Primary Outcome is Safety determined by Adverse Events [ Time Frame: 24 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Colorado Research CenterAuroraColorado80045-
Memorial Health CentralColorado SpringsColorado80909-
Memorial Hospital NorthColorado SpringsColorado80920-
Highlands Ranch HospitalHighlands RanchColorado80129-

Find similar trials in Aurora, CO

By research site
Colorado Research Center· Aurora, COMemorial Health Central· Colorado Springs, COMemorial Hospital North· Colorado Springs, COHighlands Ranch Hospital· Highlands Ranch, CO

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