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About
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.
Full 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.
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Inclusion criteria
Patients with recurrent squamous cell carcinoma or a second primary arising in a previously irradiated field
Life expectancy of greater than 6 months
Patients cannot have distant metastases and have to be candidates for curative re-irradiation
Patients with salivary gland tumors are excluded (patients with nasopharynx or sinonasal cancers can participate)
Patients with unresectable disease are eligible
Patients who undergo surgical resection will be allowed regardless of human papilloma virus (HPV) status provided they have one of the following criteria:
The majority of the anticipated target volume (> 50%) must have been previously treated to ≥ 40 Gy; prior radiation therapy (RT) must have been completed > 6 months prior to initiation of IMRT reirradiation; if previous RT records are unavailable, investigators can estimate the dose to previously treated tissues based on completion notes or other treatment history
An Eastern Cooperative Oncology Group (ECOG) performance score 0-2
Granulocytes > 1500/mm³
Platelets > 100,000/mm³
Bilirubin < 1.5 mg/dl
Creatinine < 1.5 mg/dl
No other concurrent invasive malignancies treated for the past year (localized prostate cancer or early stage skin cancer are not exclusion criteria)
Patients with carotid artery involvement or encasement will be allowed provided they have no symptoms related to carotid involvement
No prior exposure to immunotherapy agents
Ability to understand and the willingness to sign a written informed consent document
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62 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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