Phase II Randomized, Placebo- Controlled Study of Intralesional Nivolumab for High-risk Or
To evaluate the antitumor efficacy of intralesional injections of nivolumab in patients with high-risk oral premalignant lesions
| Condition(s) | Premalignant Lesion |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | To evaluate the antitumor efficacy of intralesional injections of nivolumab in patients with high-risk oral premalignant lesions |
| Who can participate | 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 biopsy. 5. Have a performance status of 0-2 on the ECOG Performance Scale. 6. Demonstrate adequate organ function as defined in Table 1 7. Female subject of childbearing potential should have a negative |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | M.D. Anderson Cancer Center |
| Locations | Houston, Texas, United States |
| Start date | 2025-02-27 |
| NCT ID | NCT06561087 |
| Official listing | https://clinicaltrials.gov/study/NCT06561087 |