M.D. Anderson Cancer Center
To evaluate the antitumor efficacy of intralesional injections of nivolumab in patients with high-risk oral premalignant lesions
Primary Objectives: To assess the oral cancer free survival following intralesional injections of nivolumab in patients with high-risk oral premalignant lesions Secondary Objectives: To describe the objective response rate (ORR) in index lesions following intralesional injections of nivolumab in patients with high-risk oral premalignant lesions, according to modified World Health Organization (WHO) criteria. To describe the pathologic complete response (CR) rate in index lesions following intralesional injections of nivolumab in patients with high-risk oral premalignant lesions. To descri…
Inclusion Criteria: 1. Presence of a treatment naïve, biopsy proven, intraoral premalignant lesion visible from oral cavity. 2. 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." 3. Be \>/= 18 years of age on day of signing informed consent. 4. Be willing to provide tissue, either archive or from a newly obtained oral b…
Given by injections
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