Phase II Randomized, Placebo- Controlled Study of Intralesional Nivolumab for High-risk Oral Premalignant Lesions

Inclusion criteria

• . Presence of a treatment naïve, biopsy proven, intraoral premalignant lesion visible from oral cavity.
• . Be willing and able to provide written informed consent for the trial. In the event that non-English speaking participants are eligible for this study, a short form (if applicable) or an ICD in their language, will be utilized and completed in accordance with the MDACC "Policy For Consenting Non-English Speaking Participants."
• . Be \>/= 18 years of age on day of signing informed consent.
• . Be willing to provide tissue, either archive or from a newly obtained oral biopsy.
• . Have a performance status of 0-2 on the ECOG Performance Scale.
• . Demonstrate adequate organ function as defined in Table 1
• . Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• . Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of study therapy through 120 days after the last dose of Nivolumab. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.

Exclusion criteria