Active — Not RecruitingPhase 1

Non-randomized, Open-label Study of Intralesional Nivolumab for High Risk Oral Premalignant Lesions

United States18 participantsStarted 2022-09-13

Plain-language summary

To characterize the safety and tolerability of nivolumab injected intralesionally in patients with high-risk oral premalignant lesions.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. 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.
✓. Have a performance status of 0-2 on the ECOG Performance Scale.
✓. Demonstrate adequate organ function as defined in Table 1
✓. Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
✓. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of study therapy through 120 days after the last dose of Nivolumab. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.

Exclusion criteria

✕. 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.
✕. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 2 or at baseline) from adverse events due to a previously administered agent.
✕. Has a known additional malignancy that is progressing or requires active treatment other than adjuvant hormonal therapy. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin or in situ cervical cancer.
✕. Has known history of, or any evidence of active, non-infectious pneumonitis.
✕. Has an active infection requiring systemic therapy.

What they're measuring

To evaluate the objective response rate (ORR) in index lesions following intralesional injections of nivolumab in patients with high-risk oral premalignant lesions, according to modified World Health Organization (WHO) criteria.

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT05327270

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02-02

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