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RECRUITING Phase 2

Safety and Efficacy Study of PRV111 and PRV211 in Subjects With Oral Squamous Cell Carcinoma

NCT05893888 · View on ClinicalTrials.gov ↗

Study 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

Interventions

  • DRUG PRV211 (Intraoperative Cisplatin System)
  • DRUG PRV111 (Cisplatin Transmucosal System)

Study Locations (4)

California

  • City of Hope National Medical Center — Duarte

Florida

  • Miami Cancer Institute — Miami

Illinois

  • The University of Chicago — Chicago

Ohio

  • The Cleveland Clinic Foundation — Cleveland

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2024-11-07
Est. Completion 2027-05-31
Phase Phase 2

Sponsor

Privo Technologies

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05893888

The ClinicalTrials.gov registry entry for NCT05893888 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Privo Technologies, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Oral Squamous Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions — of which PRV211 (Intraoperative Cisplatin System) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05893888 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05893888 about?

NCT05893888 is a clinical study titled "Safety and Efficacy Study of PRV111 and PRV211 in Subjects With Oral Squamous Cell Carcinoma". 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 L...

What is the current status of trial NCT05893888?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2024-11-07. Estimated completion is 2027-05-31.

What conditions does trial NCT05893888 study?

This clinical trial studies the following conditions: Oral Squamous Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05893888?

The interventions under investigation include: PRV211 (Intraoperative Cisplatin System) (DRUG), PRV111 (Cisplatin Transmucosal System) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05893888?

This trial is sponsored by Privo Technologies, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05893888 being conducted?

This trial has 4 study locations across California, Florida, Illinois, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial