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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

To evaluate the antitumor efficacy of intralesional injections of nivolumab in patients with high-risk oral premalignant lesions

Eligibility criteria

Qualifiers

Presence of a treatment naïve, biopsy proven, intraoral premalignant lesion visible from oral cavity.

Be willing and able to provide written informed consent for the trial. In the event that non-English speaking participants are eligible for this study, a short form (if applicable) or an ICD in their language, will be utilized and completed in accordance with the MDACC "Policy For Consenting Non-English Speaking Participants."

Be >/= 18 years of age on day of signing informed consent.

Be willing to provide tissue, either archive or from a newly obtained oral biopsy.

Disqualifiers

Is currently participating and receiving study therapy with potential anti-neoplastic activity or has participated in a study of an investigational agent and received study therapy with potential anti-neoplastic activity within 4 weeks of the first dose of treatment.

Has a known history of active TB (Bacillus Tuberculosis)

Hypersensitivity to nivolumab or any of its excipients.

Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 2 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.

Trial design

Treatments tested in this trial

  • Nivolumab

Treatment groups

45 Participants
are divided into 1 treatment group

Sponsors and collaborators