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.

NCT06561087

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~45 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Nivolumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and AdverseEevents (AEs)
Measured over Through study completion; an average of 1 year
Premalignant Lesion
1 sites across 1 states
Texas1
  • Moran Amit, MD, PHD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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  • 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