A Phase II/III Randomized Study of Maintenance Nivolumab Versus Observation in Patients With Locally Advanced, Intermediate Risk HPV Positive OPCA.

This phase II/III trial studies how well chemotherapy and radiation therapy with nivolumab or observation work in treating patients with intermediate risk HPV-positive oropharyngeal cancer that has spread to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether chemotherapy and radiation therapy with nivolumab or observation works better in treating patients with HPV-positive oropharyngeal cancer.

Key Eligibility:
• Patients must have oropharynx cancer that is p16-positive by immunohistochemistry with smoking status.
• Patients must not have had prior systemic therapy or radiation treatment for p16 positive oropharyngeal squamous cell carcinoma (OPSCC).
• Patients must not have received previous irradiation for head and neck tumor, skull base, or brain tumors.
• Patients with evidence of distant metastases or leptomeningeal disease (LMD) are excluded.
• Patients with a history of a different malignancy are excluded, unless the disease has not progressed for greater than or equal 2 years.
Phase II/III
Oral, Head and Neck
Alison Conlin, M.D.
George Morris

The Pacific Cancer Research Consortium clinical trials are offered at multiple locations throughout Oregon, Washington, Alaska, California, and Idaho. To find a location near you, please contact the Patient Engagement Center at 844-552-2734.