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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: Recruiting Phase 2 study of Oral Squamous Cell Carcinoma, sponsored by Privo Technologies.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Proportion of treated tumors that have a response to PRV111 treatment. Response is defined as either or both: 1) histopathological downgrade of the disease such as partial or complete response as determined by post-treatment biopsies compared to baseline, or 2) clinically measurable tumor volume reduction from baseline of 30% or more from baseline.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-11-07 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 2 |
What NCT05893888 shows while recruiting
NCT05893888 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 338-participant average among 5 other Oral Squamous Cell Carcinoma trials with a reported enrollment target (88% lower).
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 a single indexed study location in 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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