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 (May 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
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage TIS, CIS
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
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 →
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