Safety and Efficacy Study of PRV111 and PRV211 in Subjects With Oral Squamous Cell Carcinoma
Trial Parameters
Brief 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 Subject Assignment: Subjects will be assigned to Arm 1 or Arm 2 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
Eligibility Criteria
Different diagnosis for ARM 1 \& ARM 2, however the rest of inclusion criteria are the same for both arms: In order to be eligible to participate in the study, an individual must meet all of the following criteria: • Diagnosis 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 Criteria for Inclusion for both ARM 1 \& ARM 2: 1. Tumors for which the cytological and architectural changes upon histopathological assessment warrant surgical intervention 2. Adult subjects, men and women, defined by age ≥18 years at the time of screening. 3. Tumor must be accessible, with no evidence of infection or active bleeding. 4. Tumor is amenable to surgical resection within 8 weeks of screening visit (Visit 0). 5. Clinically and/or radiologically measurable tumor. 6. Eastern Collaborative Oncology Group Performance Status of ≤2. 7. Male and female subjects of childbearing po