IRB Study Number 24-1142
Status Recruiting
Institute Taussig Cancer Institute
Description
Primary Objectives:
To determine the safety profile of PRV211 treatment
Secondary Objectives:
Event free survival (EFS). An event is defined as: salvage surgery, locoregional recurrence at 12 months or death due to any cause.
Inclusion Criteria
Adult subjects, men and women, defined by age ≥18 years at the time of screening.
Pathologically proven and clinically confirmed HGD /CIS of the lip or oral cavity
Tumors that warrant surgical intervention
Clinically and/or radiologically measurable tumor
Eastern Collaborative Oncology Group Performance Status of ≤2
Have a life expectancy of ≥3 months
Willing and able to provide written informed consent
Able to return to study site for treatment visits as defined in the Protocol
Absence of any serious underlying medical conditions, which could impair the ability of the subject to participate in the study
Subjects of childbearing potential should agree to two (2) methods of Birth Control
Exclusion Criteria
Tumors that are actively bleeding or infected
Patients with a prior history of T3-T4 invasive oral squamous cell carcinoma within the last 6 months.
Any tumors located in the lip/oral cavity where the location would preclude the
PRV111 patch from complete contact with the tumor during treatment
Patients with concurrent documented malignancy that requires systemic therapy, those with metastasized malignancies, or uncontrolled malignancies
Exposure to any investigational agent within 3 months prior to Screening
Known allergy or hypersensitivity to platinum-containing agents, or known intolerance to a prior platinum- containing agent, or to any of the excipients, which, in the judgement of the physician will preclude re- exposure to platinum-containing agent
Active, uncontrolled infection requiring systemic therapy, such as but not limited to HIV, Syphilis, Hepatitis B, or Hepatitis C
Uncontrolled intercurrent illness that would risk subject safety, interfere with the objectives of the Protocol, or limit subject compliance with study requirements, as determined by the Investigator
Known or suspected pregnancy, planned pregnancy, or lactation.
Any medical or psychiatric condition that may compromise the ability to give written informed consent
