Safety and Efficacy of Nivolumab in Treating Oral Proliferative Verrucous Leukoplakia (NCT03692325) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of Nivolumab in Treating Oral Proliferative Verrucous Leukoplakia
United States33 participantsStarted 2018-12-05
Plain-language summary
This research study is studying an immunotherapy drug, as a possible treatment for oral proliferative verrucous leukoplakia (OPVL).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subject must have histologically confirmed oral proliferative verrucous leukoplakia (OPVL), as defined by: multifocal lesions (≥ 2) or contiguous lesions ≥ 3 cm or a single lesion ≥ 4 cm in largest diameter (at least one lesion with any degree of dysplasia). (Note: no restriction on the length of time that patients have had one or more existing lesions)
* Willing to provide blood and tissue from diagnostic biopsies
* Any smoking history is permitted. A history of prior or current tobacco use is not an exclusion criteria. While discouraged, patients are permitted to continue tobacco use while on the study.
* Age 18 years or older
* ECOG performance status ≤ 2 (Karnofsky ≥60%, see Appendix A)
* Participant must have normal organ and marrow function as defined below within 21 days prior to study registration:
* leukocytes ≥3,000/mcL
* absolute neutrophil count ≥1,000/mcL
* platelets ≥100,000/mcL
* total bilirubin ≤2.0 g/dL
* AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
* creatinine within normal institutional limits OR
* creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal
* Ability to understand and the willingness to sign a written informed consent document
* Women of childbearing potential (WOCBP) must agree to use appropriate method(s) of contraception. WOCBP should plan to use an adequate method to avoid pregnancy for 5 months (30 days plus the time required for niv…
What they're measuring
1
Best Overall Response Rate (BORR)
Timeframe: Participants were followed up to 164 days.