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

NCT05053737 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-02-03

No results posted yet for this study

Summary

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.

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Interventions

DRUG

Atezolizumab

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.

RADIATION

Stereotactic Body Radiation Therapy

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.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Sana Karam, MD · University of Colorado, Denver

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2023-11-24
Completion
2024-06-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05053737 on ClinicalTrials.gov