A Study Evaluating the Safety and Efficacy of PRV111, PRV211, and PRV131 in Subjects With Oral and Lung Cancers
Public ClinicalTrials.gov record NCT05893888. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2/3 Multicenter Study Evaluating the PRV Platform of Localized Nanoengineered Therapies for Oral Cavity and Lung Cancers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT05893888
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 40 participants
Conditions and interventions
Conditions
Interventions
- PRV211 (Intraoperative Cisplatin System) Drug
- PRV111 (Cisplatin Transmucosal System) Drug
- PRV131 (Cisplatin Intratumoral Injectable) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 6, 2024
- Primary completion
- Sep 30, 2026
- Completion
- May 30, 2027
- Last update posted
- Apr 22, 2026
2024 – 2027
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | Recruiting |
| Miami Cancer Institute | Miami | Florida | 33176 | Recruiting |
| The University of Chicago | Chicago | Illinois | 60637 | Recruiting |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05893888, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 22, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05893888 live on ClinicalTrials.gov.