Phase II Randomized, Placebo- Controlled Study of Intralesional Nivolumab for High-risk Oral Premalignant Lesions
- Conditions
- Premalignant Lesion
- Registration Number
- NCT06561087
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Presence of a treatment naïve, biopsy proven, intraoral premalignant lesion visible<br> from oral cavity.<br><br> 2. Be willing and able to provide written informed consent for the trial. In the event<br> that non-English speaking participants are eligible for this study, a short form (if<br> applicable) or an ICD in their language, will be utilized and completed in<br> accordance with the MDACC Policy For Consenting Non-English Speaking Participants.<br><br> 3. Be >/= 18 years of age on day of signing informed consent.<br><br> 4. Be willing to provide tissue, either archive or from a newly obtained oral biopsy.<br><br> 5. Have a performance status of 0-2 on the ECOG Performance Scale.<br><br> 6. Demonstrate adequate organ function as defined in Table 1<br><br> 7. Female subject of childbearing potential should have a negative urine or serum<br> pregnancy test within 72 hours prior to receiving the first dose of study<br> medication. If the urine test is positive or cannot be confirmed as negative, a<br> serum pregnancy test will be required.<br><br> 8. Female subjects of childbearing potential should be willing to use 2 methods of<br> birth control or be surgically sterile or abstain from heterosexual activity for the<br> course of study therapy through 120 days after the last dose of Nivolumab. Subjects<br> of childbearing potential are those who have not been surgically sterilized or have<br> not been free from menses for > 1 year.<br><br> 9. Male subjects should agree to use an adequate method of contraception starting with<br> the first dose of study therapy through 120 days after the last dose of study<br> therapy.<br><br>Exclusion Criteria:<br><br> 1. Is currently participating and receiving study therapy with potential<br> anti-neoplastic activity or has participated in a study of an investigational agent<br> and received study therapy with potential anti-neoplastic activity within 4 weeks of<br> the first dose of treatment.<br><br> 2. Has a known history of active TB (Bacillus Tuberculosis)<br><br> 3. Hypersensitivity to nivolumab or any of its excipients.<br><br> 4. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study<br> Day 1 or who has not recovered (i.e., = Grade 2 or at baseline) from adverse events<br> due to agents administered more than 4 weeks earlier.<br><br> 5. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy<br> within 2 weeks prior to study Day 1 or who has not recovered (i.e., = Grade 2 or at<br> baseline) from adverse events due to a previously administered agent.<br><br> 6. Has a known additional malignancy that is progressing or requires active treatment<br> other than adjuvant hormonal therapy. Exceptions include basal cell carcinoma of the<br> skin or squamous cell carcinoma of the skin or in situ cervical cancer.<br><br> 7. Has known history of, or any evidence of active, non-infectious pneumonitis.<br><br> 8. Has an active infection requiring systemic therapy.<br><br> 9. Has a history or current evidence of any condition, therapy, or laboratory<br> abnormality that might confound the results of the trial, interfere with the<br> subject's participation for the full duration of the trial, or is not in the best<br> interest of the subject to participate, in the opinion of the treating investigator.<br><br> 10. Has known psychiatric or substance abuse disorders that would interfere with<br> cooperation with the requirements of the trial.<br><br> 11. Is pregnant or breastfeeding or expecting to conceive or father children within the<br> projected duration of treatment with nivolumab, starting with the pre-screening or<br> screening visit through 120 days after the last dose of trial treatment.<br><br> 12. Has received a live vaccine within 30 days of planned start of study therapy.<br><br>Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines<br>and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live<br>attenuated vaccines, and are not allowed.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and AdverseEevents (AEs)
- Secondary Outcome Measures
Name Time Method