Safety and Efficacy of Nivolumab in Treating Oral Proliferative Verrucous Leukoplakia

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03692325
Phase
PHASE2
Status
Completed

Conditions

  • Leukoplakia, Oral

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells.

Study Details

This research study is studying an immunotherapy drug, as a possible treatment for oral proliferative verrucous leukoplakia (OPVL).

Key Dates

Start date
Dec 5, 2018
Status verified
Sep 2024
Primary completion
Sep 1, 2022
Completion
Aug 30, 2024

Study Design

Enrollment
33 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Nivolumab
    * Nivolumab will be administered by IV infusion on Day 1 of each 28-day cycle * Treatment with the study drug will continue for a maximum of 4 cycles or until unacceptable toxicity or withdrawal of consent

Primary Outcome Measure

Best Overall Response Rate (BORR) [ Time Frame: Participants were followed up to 164 days. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-

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