NCT05053737

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

Phase I/II Trial of Radiotherapy in Combination With Atezolizumab Prior to Surgical Resection for HPV-unrelated Squamous Cell Carcinoma of the Head and Neck (HNSCC)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Hypothesis: that the addition of SBRT to neoadjuvant checkpoint inhibition would be safe and would prime the immune system and improve the chances of a successful surgery and overall survival. The preliminary analysis demonstrated the safety of dose escalation of anti-PD-L1-RT to 18Gy in 3 fractions. In this study, the maximum dose to the tumor was escalated to 133%, an equivalent dose of 24 Gy in 3 fractions, with no safety or unexpected surgical issues encountered. At interim analysis, counting all patients, even those treated for the 12Gy in 2 fractions and even those that received surgery at 2 weeks, the rate of pTR-2 or greater was close to 100%. With only 11 analyzable patients and counting those who received the dose escalated 18 Gy in 3 fractions radiation with anti-PD-L1, investigators have observed much higher pathological responses. Another group of investigators has also demonstrated the safety of delivering 24 Gy in 3 fractions with anti-PD-L1 (https://clincancerres.aacrjournals.org/content/26/12\_Supplement\_2/B01). Given the safety and preliminary efficacy of 24 Gy in 3 fractions SBRT with anti-PD-L1 therapy in the neoadjuvant setting, the investigators propose the present study to assess the impact of this regimen on pathologic tumor response rate.

Conditions

• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-02
• Primary completion: 2023-11-24
• Completion: 2024-06-21
• First posted: 2021-09-22
• Last updated: 2025-02-03

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study