Non-randomized, Open-label Study of Intralesional Nivolumab for High Risk Oral Premalignant Lesions

Exclusion Criteria

• •The subject must be excluded from the trial if the subject:
• •1. Is currently participating and receiving study therapy with potential anti-neoplastic activity or has participated in a study of an investigational agent and received study therapy with potential anti-neoplastic activity within 4 weeks of the first dose of treatment.
• •2. Has a known history of active TB (Bacillus Tuberculosis)
• •3. Hypersensitivity to nivolumab or any of its excipients.
• •4. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 2 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
• •5. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 2 or at baseline) from adverse events due to a previously administered agent.
• •6. Has a known additional malignancy that is progressing or requires active treatment other than adjuvant hormonal therapy. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin or in situ cervical cancer.
• •7. Has known history of, or any evidence of active, non-infectious pneumonitis.
• •8. Has an active infection requiring systemic therapy.
• •9. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• •10. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• •11. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of treatment with pembrolizumab, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
• •12. Has received a live vaccine within 30 days of planned start of study therapy.
• •Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live