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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 help make tumor cells more sensitive to the radiation therapy. 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. ;


Study Design


Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Metastatic Head and Neck Squamous Cell Carcinoma
  • 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
Contact
Status Recruiting
Phase Phase 2
Start date April 7, 2021
Completion date September 30, 2026

See also
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