Clinical Trials
Sponsor:
Sponsor Study ID:
Study Title:
A Phase II/III Randomized Study of Maintenance Nivolumab Versus Observation in Patients With Locally Advanced, Intermediate Risk HPV Positive OPCA
NCT Number:
NCT03811015
Phase:
II/III
Protocol Type:
Treatment
Age Group:
Adults
Disease Sites:
Lip, Oral Cavity and Pharynx
Study Objectives:
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.
Study Documents
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