A Study Evaluating the Safety and Efficacy of PRV111, PRV211, and PRV131 in Subjects With Oral an… (NCT05893888) | Clinical Trial Compass
RecruitingPhase 2/3
A Study Evaluating the Safety and Efficacy of PRV111, PRV211, and PRV131 in Subjects With Oral and Lung Cancers
United States40 participantsStarted 2024-11-07
Plain-language summary
Arm 1 ( Phase 2/3 Run in ):
PRV111: Topical Locoregional Delivery Placed Over the Tumor Region Primary Endpoint: Overall Response Rate (ORR) Primary Objective: Demonstrate the safety and efficacy of PRV111 in patients with Carcinoma in Situ (CIS) (WHO 2017)
Arm 2 (Phase 1) PRV211: Intraoperative Locoregional Delivery Placed into the Resected Tumor Bed Primary Endpoint: Safety Primary Objective: Determine Safety of PRV211 in intraoperative setting
Arm 3 (Phase 1/2) PRV131: Intratumoral Injectable delivery into the Tumor Primary Endpoint: Safety and Objective Response Rate (ORR) Primary objective: Determine a safe and effective dose for PRV131 intratumoral injectable
Subject Assignment: Subjects will be assigned to Arm 1, Arm 2, or Arm 3 of this study based on disease staging Arm 1: Pathologically proven and clinically confirmed Tis/CIS of the lip or oral cavity Arm 2: Pathologically proven and clinically confirmed T1-T3, Nx, M0 of the lip or oral cavity Arm 3a: Histologically confirmed squamous cell carcinoma (SCC) of the oral cavity, classified as clinical stage T1-T3, N0-1, M0 Arm 3b: Histologically confirmed malignant tumor in the lungs (primary or secondary), classified as clinical stage T1-2, N0, M0
Who can participate
Age range18 Years – 100 Years
SexALL
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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).
✓. 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.
✓
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: 6-7 months
2
Safety assessed via dose-limiting toxicities
Timeframe: 1-month post-surgery and through study completion, ~12-14 months
. Absence of any serious underlying medical conditions which could impair the ability of the subject to participate in the study.
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.(Arm 1 only)
✕. Systemic chemotherapy for the treatment of SCC of the head and neck less than 2 years prior to Screening (Arm 1 only)
✕. 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