Study of Nivolumab for High-Risk Oral Premalignant Lesions
This study is testing a drug called nivolumab, given by injections, for people with high-risk oral premalignant lesions (abnormal cells in the mouth that could become cancer). Researchers want to see if nivolumab can help prevent these lesions from turning into oral cancer. You might be able to join if you are 18 or older, have a newly diagnosed oral premalignant lesion inside your mouth, and are willing to give written consent. The study aims to see how safe nivolumab is and how well it helps keep people free from oral cancer. The current status of this study is unclear, and it plans to enroll 45 participants.
- Study design
- This is a randomized, placebo-controlled study, meaning some participants will receive nivolumab and others will receive a placebo (an inactive substance). It plans to enroll 45 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and side effects will be measured throughout the study, which is expected to last an average of 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase II Randomized, Placebo- Controlled Study of Intralesional Nivolumab for High-risk Oral Premalignant Lesions
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Moran Amit, MD, PHD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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What this trial measures
- Safety and AdverseEevents (AEs)Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0