Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Emory University
With
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
