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
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the antitumor efficacy of intralesional injections of nivolumab in patients with high-risk oral premalignant lesions
CONDITIONS
Official 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 from the oral cavity
- Willing and able to provide written informed consent for the trial
- Age 18 years or older on the day of signing informed consent
- Willing to provide tissue either from archive or a newly obtained oral biopsy
- Performance status of 0-2 on the ECOG Performance Scale
- Adequate organ function as defined in the study
- Female participants of childbearing potential must have a negative pregnancy test within 72 hours before first dose
- Female participants of childbearing potential must use two methods of birth control, be surgically sterile, or abstain from heterosexual activity during study therapy and for 120 days after last dose
- Male participants must agree to use adequate contraception from first dose through 120 days after last dose
You will not qualify if you...
- Currently participating in or received study therapy with potential anti-cancer activity within 4 weeks before treatment
- Known history of active tuberculosis
- Hypersensitivity to nivolumab or its excipients
- Prior anti-cancer monoclonal antibody treatment within 4 weeks before Day 1 or not recovered from related adverse events
- Prior chemotherapy, targeted therapy, or radiation within 2 weeks before Day 1 or not recovered from related adverse events
- Known 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, therapies, or lab abnormalities that might interfere with study participation or results
- Psychiatric or substance abuse disorders interfering with trial cooperation
- Pregnant, breastfeeding, or planning pregnancy/fathering children during treatment and 120 days after
- Received live vaccine within 30 days before study therapy start (except inactivated seasonal flu vaccine)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77090
Actively Recruiting
Research Team
M
Moran Amit, MD, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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