OncoMatch/Clinical Trials/NCT05893888
Safety and Efficacy Study of PRV111 and PRV211 in Subjects With Oral Squamous Cell Carcinoma
Is NCT05893888 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2/3 trial studies multiple treatments including PRV211 (Intraoperative Cisplatin System) and PRV111 (Cisplatin Transmucosal System) for oral squamous cell carcinoma.
Treatment: PRV211 (Intraoperative Cisplatin System) · PRV111 (Cisplatin Transmucosal System) — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage TIS, CIS
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: radiation therapy
Squamous cell carcinoma (SCC) of the oral cavity that received previous radiotherapy.(Arm 1 only)
Cannot have received: systemic chemotherapy
Exception: for the treatment of SCC of the head and neck less than 2 years prior to Screening (Arm 1 only)
Systemic chemotherapy for the treatment of SCC of the head and neck less than 2 years prior to Screening (Arm 1 only)
Cannot have received: investigational agent
Exception: within 3 months prior to Screening
Exposure to any investigational agent within 3 months prior to Screening
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The Cleveland Clinic Foundation · Cleveland, Ohio
- City of Hope National Medical Center · Duarte, California
- Miami Cancer Institute · Miami, Florida
- The University of Chicago · Chicago, Illinois
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05893888 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radiation therapy, systemic chemotherapy, investigational agent disqualifies patients from enrollment.
What disease stage is eligible?
Stage TIS or CIS is required.
Is there an age limit?
Yes. Patients must be 100 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages