Stopped: funding and drug were withdrawn
This phase I trial studies the side effects of nivolumab and IRX-2 and how well they work in treating participants with stage III-IVA oral cavity cancer or human papillomavirus (HPV)-positive oropharyngeal cancer that can be removed by surgery. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. IRX-2 may "turn on" the immune system and stimulate an immune response against tumor cells. Giving nivolumab and IRX-2 followed by surgery may work better at treating oral cavity and oropharyngeal cancer.
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Incidence of adverse events (AEs) described using Common Terminology Criteria for Adverse Events 4.03
Timeframe: Up to 4 years
Change in tumor size determined by central radiology review by radiologists blinded to the treatment regimen
Timeframe: Baseline up to 4 years