NBTXR3, Radiation Therapy, and Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Cancer

Recurrent Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title: Phase II Study of NBTXR3 Activated by Radiation and Combined With Pembrolizumab for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma With Limited PD-L1 Expression or Refractory to PD-1 Blockade

Status Recruiting

Clinical Trial Summary

This phase II trial investigates the effect of NBTXR3, radiation therapy, and pembrolizumab in treating patients with head and neck squamous cancer that has come back (recurrent) or has spread to other places in the body (metastatic). NBTXR3 may cause cell destruction when activated by radiation. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. And hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving NBTXR3, radiation therapy, and pembrolizumab may kill more tumor cells.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. To evaluate tumor response of hafnium oxide-containing nanoparticles NBTXR3 (NBTXR3) activated by radiation therapy (RT) in combination with pembrolizumab in patients with recurrent/metastatic (R/M) head and neck squamous cell cancer (HNSCC).

SECONDARY OBJECTIVES:

I. To assess unacceptable treatment-related toxicity of NBTXR3 activated by RT in combination with pembrolizumab in patients with R/M HNSCC.

II. To assess the safety profile of NBTXR3 activated RT in combination with pembrolizumab in patients with R/M HNSCC.

III. To evaluate time-to-event outcomes of NBTXR3 activated by RT in combination with pembrolizumab in patients with R/M HNSCC.

EXPLORATORY OBJECTIVES:

I. To associate radiomic measurements with outcomes of treatment with NBTXR3 activated by RT in combination with pembrolizumab.

II. To evaluate biomarkers of response in subjects treated with NBTXR3 activated by RT in combination with pembrolizumab.

OUTLINE:

Patients receive hafnium oxide-containing nanoparticles NBTXR3 via injection intratumorally or intranodally on day 1. Beginning as early as day 3 and within 8 days of NBTXR3 injection, patients undergo stereotactic body radiation therapy (SBRT) every other day (QOD) or hypofractionated RT once daily (QD) over 1-2 weeks at the discretion of the treating radiation oncologist. Starting on the same day as radiation therapy, patients also receive pembrolizumab intravenously (IV) over 30 minutes every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 weeks for 2 years. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Metastatic Head and Neck Squamous Cell Carcinoma
• Recurrence
• Recurrent Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

• NCT number: NCT04862455
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Recruiting
• Phase: Phase 2
• Start date: April 7, 2021
• Completion date: September 30, 2026