A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma

Exclusion criteria

• ✕. Patients with symptomatic CNS metastases must have been treated, be asymptomatic, and not have any of the following at the time of enrollment:
• ✕. Need for concurrent treatment for the CNS disease (eg, surgery, radiation, corticosteroids \>10 mg prednisone/day or equivalent);
• ✕. Progression of CNS metastases on MRI or CT for at least 28 days after last day of prior therapy for the CNS metastases; and/or
• ✕. Concurrent leptomeningeal disease or cord compression.
• ✕. Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
• ✕. History of prior allogeneic bone marrow, stem-cell or solid organ transplantation
• ✕. Treatment with any systemic anti-neoplastic therapy, or investigational therapy within the 2 weeks (or 4 weeks, for antibody drugs), prior to the initiation of study drug administration. Patients may be on an investigational or other anti-neoplastic therapy during the screening phase of the study.
• ✕. Treatment with radiation therapy within 2 weeks prior to the initiation of study drug administration.