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Throat Cancer EA Testing Immunotherapy versus Observation in Patients with HPV Throat Cancer STATUS: Temporarily Closed to Accrual Description This phase III trials studies whether maintenance immunotherapy nivolumab following definitive treatment with radiation and chemotherapy cisplatin result in significant improvement in overall survival time being alive and progression-free survival time being alive without cancer for patients with intermediate risk human papillomavirus HPV positive oropharynx cancer throat 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 followed by maintenance nivolumab therapy works better than chemotherapy and radiation therapy alone in treating patients with HPV positive oropharyngeal cancer. STEP 1: Patients with a history of allergic reactions attributed to platinum-based chemotherapy agents are excluded.
STEP 1: Patients must not receive investigational agents within 4 weeks of enrollment or at any time while on study. STEP 1: Patients with uncontrolled inter-current illnesses which in the opinion of the investigator will interfere with the ability to undergo therapy including chemotherapy are excluded. All patients of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy.
A patient of childbearing potential is any female, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1 has achieved menarche at some point, 2 has not undergone a hysterectomy or bilateral oophorectomy or 3 has not been naturally postmenopausal amenorrhea following cancer therapy does not rule out childbearing potential for at least 24 consecutive months i.