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

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.