Window of Opportunity Trial of Nivolumab and Tadalafil in Patients With Squamous Cell Carcinoma of the Head and Neck

Exclusion Criteria

• •Patients with nasopharyngeal carcinoma, salivary gland or skin primaries
• •Patients with any anginal chest pain; defined by a known diagnosis of angina; or defined by chest pressure, squeezing, radiating pain to arms, shoulders, or neck from the chest; with or without exertion
• •Patients taking nitrates
• •Patients taking PDE5 inhibitors more then 1/week during the previous 28 days
• •Patients with a secondary condition (sickle cell anemia) that cause priapism
• •Any history of a severe hypersensitivity reaction to any monoclonal antibody
• •Any history of allergy to the study drug components
• •Any concurrent malignancies; exceptions include- basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or in situ cervical cancer that has undergone potentially curative therapy; patients with a history of other prior malignancy must have been treated with curative intent and must have remained disease-free for 2 years post-diagnosis
• •Any diagnosis of immunodeficiency or current immunosuppressive therapy including \>10mg/day of prednisone within 14 days of enrollment is not permitted.
• •Patients that have an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids (\> 10 mg daily prednisone equivalents) or immunosuppressive agents; subjects with vitiligo, type I diabetes mellitus, or resolved childhood asthma/atopy would be an exception to this rule. Inhaled or topical steroids, and adrena replacement steroid doses =\<10mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study
• •Patients must not be receiving any other investigational agents
• •Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial
• •Patients must not be pregnant or breastfeeding
• •Patients with a known human immunodeficiency virus infection (HIV 1/2 antibodies) or acquired immunodeficiency syndrome (HIV/AIDS), active hepatitis B (e.g., hepatitis B surface antigen \[HBsAg\] reactive) or hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected)
• •Patients with any evidence of current interstitial lung disease (ILD) or pneumonitis
• •Patients with prior history of ILD or non-infectious pneumonitis that required steroids
• •Patients who have received a live vaccine within 30 days of the planned start of study therapy