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NCT05893888 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Oral Squamous Cell Carcinoma, sponsored by Privo Technologies.

Recruiting
Registry status
Phase 2
Development phase
40
Enrollment target
4
Study locations

NCT05893888 is a Phase 2 study of Oral Squamous Cell Carcinoma that is actively recruiting participants, run by Privo Technologies. The registered enrollment target is 40 participants, below the 338-participant average among 5 other Oral Squamous Cell Carcinoma trials with a reported enrollment target (88% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT05893888, a Phase 2 study of Oral Squamous Cell Carcinoma, is actively recruiting participants, sponsored by Privo Technologies.

RECRUITING
Registry status
Phase 2
Development phase
40 participants
Enrollment target
4
Study locations

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

Conditions Studied

Oral Squamous Cell Carcinoma

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

2 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, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 338-participant average among 5 other Oral Squamous Cell Carcinoma trials with a reported enrollment target (88% lower). The listed sponsor is Privo Technologies, which has 2 total studies on file at ClinicalTrials.gov.

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.

NCT05893888 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Florida, Illinois.

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.

What interventions are being tested in trial NCT05893888?

The interventions under investigation include: PRV211 (Intraoperative Cisplatin System) (DRUG), PRV111 (Cisplatin Transmucosal System) (DRUG).

Who is sponsoring clinical trial NCT05893888?

This trial is sponsored by Privo Technologies, which has 2 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.