NCT03521570

Intensity-Modulated Radiation Therapy & Nivolumab for Recurrent or Second Primary Head & Neck Squamous Cell Cancer

Phase II Study of IMRT Re-Irradiation With Concurrent/Adjuvant Nivolumab in Patients With Locoregionally Recurrent or Second Primary Squamous Cell Cancer of the Head and Neck

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well intensity-modulated radiotherapy and nivolumab work together in treating patients with head and neck squamous cell cancer that has come back. Intensity-modulation radiation therapy uses varying intensities of radiation beams to kill cancer cells and shrink tumors, thereby reducing the damage to nearby healthy tissue. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving intensity-modulated radiation therapy and nivolumab may work better at treating head and neck squamous cell cancer.

Detailed description

PRIMARY OBJECTIVE: I. To assess the 1-year progression-free survival (PFS) for patients with recurrent or second primary head and neck squamous cancer treated with intensity-modulated radiation therapy (IMRT) re-irradiation with concurrent and adjuvant nivolumab. SECONDARY OBJECTIVES: I. Evaluate the 1-year (yr) overall survival (OS) of patients treated with re-irradiation and nivolumab. II. Evaluate patient quality of life (QOL). III. Evaluate patterns of failure including local, regional and distant failure rates at 1 yr. IV. Identify and estimate the incidence rate of acute and late toxicities associated with combined re-irradiation and concurrent and adjuvant nivolumab. TERTIARY OBJECTIVE: I. To identify potential biomarkers related to clinical benefit to concurrent and adjuvant nivolumab and re-irradiation in patients with recurrent or second primary (RSP) head and neck squamous cell carcinoma (HNSCC). OUTLINE: Patients receive nivolumab intravenously (IV) over 30 minutes on weeks -2, 0, 2, 4, and 6 and undergo IMRT once daily beginning on week 0 for up to 6-6.5 weeks. Beginning week 10, patients receive nivolumab IV over 30 minutes every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years from the beginning of radiation therapy.

Conditions

• Recurrent Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
RADIATION	IMRT	Undergo intensity-modulated radiation therapy
BIOLOGICAL	Nivolumab	Given IV

Timeline

• Start date: 2018-06-28
• Primary completion: 2022-07-25
• Completion: 2023-09-07
• First posted: 2018-05-11
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study