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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Number of Participants With Progression-Free Survival (PFS)
95% confidence interval will be estimated by Kaplan-Meier method for all participants.
Time frame: 1 year from study start
Number of Participants With Overall Survival (OS)
Will be assessed using Kaplan-Meier method.
Time frame: 1 year from study start
Number of Participants With Pattern of Failure
To evaluate patterns of failure as local, regional, or distant.
Time frame: 1 year from study start
Number of Participants With Incidence of Acute Adverse Events
Acute toxicities will be identified and their incidence rate estimated.
Time frame: Up to 1 year from study start
Number of Participants With Incidence of Late Adverse Events
Late toxicities will be identified and their incidence rate estimated.
Time frame: 2 years from study start
Quality of Life (QOL)
The FACT-HN (Functional Assessment of Cancer Therapy-Head and Neck) (version 4) consists of a cancer-specific questionnaire, FACT-G (Functional Assessment of Cancer Therapy - General), in addition to 12 H\&N cancer-specific items (the HN subscale).The Functional Assessment of Cancer Therapy-Head and Neck Quality of Life questionnaire may be completed by the patient using paper or electronically. FACT-HN total score ranges between 0 and 148. The higher the score, the better the QOL
Time frame: At baseline, end of Intensity-Modulated Radiation Therapy, and weeks 18, 30, 52, and 104, baseline and month 12
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