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
Tumors for which the cytological and architectural changes upon histopathological assessment warrant surgical intervention
Adult subjects, men and women, defined by age ≥18 years at the time of screening.
Tumor must be accessible, with no evidence of infection or active bleeding.
Tumor is amenable to surgical resection within 8 weeks of screening visit (Visit 0).
Clinically and/or radiologically measurable tumor.
Eastern Collaborative Oncology Group Performance Status of ≤2.
Male and female subjects of childbearing potential must agree to use 2 methods of effective contraception from screening and for at least 30 days after the final dose of investigational product. Appropriate birth control is defined as barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices, or naturally or surgically sterile (with documentation in the subject's medical records). Postmenopausal women are defined as presenting at least 12 months’ natural spontaneous amenorrhea, or at least 6 weeks following surgical menopause (bilateral oophorectomy). Females of childbearing potential must be non-lactating and have a negative serum hCG within 14 days of treatment initiation.
Absence of any serious underlying medical conditions which could impair the ability of the subject to participate in the study.
Have a life expectancy of ≥3 months.
Willing and able to provide written informed consent.
Able to return to study site for treatment and follow-up visits as defined in the Protocol.
Exclusion Criteria
Subjects that are not eligible for surgery as SOC.
Patients with a prior history of invasive squamous cell carcinoma (Arm 1 only)
Tumors involving the marginal gingiva (Arm 1 only)
Squamous cell carcinoma (SCC) of the oral cavity that received previous radiotherapy.
Systemic chemotherapy for the treatment of SCC of the head and neck less than 2 years prior to Screening
Concurrent documented malignancy, with the exception of localized SCCs and basal cell carcinoma of the skin 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
Known diagnosis of oral submucous fibrosis (Arm 1 only)
Known diagnosis of trismus (Arm 1 only)
