Actively Recruiting
Phase II Randomized, Placebo-Controlled Study of Intralesional Nivolumab for High-risk Oral Premalignant Lesions
Led by M.D. Anderson Cancer Center · Updated on 2026-03-02
45
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the antitumor effects of intralesional injections of nivolumab in patients with high-risk oral premalignant lesions. This Phase II randomized, placebo-controlled study aims to assess oral cancer-free survival and response rates in these lesions. The trial also measures the pathologic complete response and major pathologic response rates following treatment. Participants will receive injections of nivolumab directly into the premalignant lesions or a placebo. The study involves screening patients for loss of heterozygosity LOH and then randomly assigning them to receive either the experimental drug or placebo. The treatment period and dosing schedule are designed to evaluate the safety and antitumor activity of nivolumab in this patient group. Throughout the study, participants will undergo assessments to monitor safety and adverse events over approximately one year. Researchers will also evaluate lesion responses using modified World Health Organization criteria. Patients will provide tissue samples from biopsies, and their overall health and organ function will be monitored. The study duration includes screening, treatment, and follow-up to observe treatment effects and safety.
CONDITIONS
Brief Title
Phase II Randomized, Placebo- Controlled Study of Intralesional Nivolumab for High-risk Oral Premalignant Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of a treatment-naïve, biopsy-proven, intraoral premalignant lesion visible in the oral cavity
- Willing and able to provide written informed consent for the trial
- 18 years of age or older at the time of signing informed consent
- Willing to provide tissue samples from archive or newly obtained oral biopsy
- Performance status of 0-2 on the ECOG Performance Scale
- Adequate organ function as defined by study requirements
- Female participants of childbearing potential must have a negative pregnancy test within 72 hours before first dose
- Female participants of childbearing potential must agree to use two methods of birth control, be surgically sterile, or abstain from heterosexual activity during and 120 days after treatment
- Male participants must agree to use adequate contraception during and 120 days after treatment
You will not qualify if you...
- Currently receiving or recently received investigational anti-neoplastic therapy within 4 weeks prior to treatment start
- History of active tuberculosis
- Allergic to nivolumab or its components
- Prior anti-cancer monoclonal antibody treatment within 4 weeks or unresolved adverse events from such treatment
- Prior chemotherapy, targeted therapy, or radiation within 2 weeks or unresolved adverse events from such treatments
- Additional progressing malignancy requiring active treatment, except certain skin cancers or in situ cervical cancer
- History or evidence of active non-infectious pneumonitis
- Active infection requiring systemic therapy
- Conditions or therapies that could interfere with trial participation or safety
- Psychiatric or substance abuse disorders that impair trial cooperation
- Pregnant, breastfeeding, or planning to conceive during treatment and 120 days after
- Received live vaccine within 30 days before starting study therapy; seasonal inactivated flu vaccines allowed
Research Team
M
Moran Amit, MD, PHD
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