OncoMatch/Clinical Trials/NCT05893888
A Study Evaluating the Safety and Efficacy of PRV111, PRV211, and PRV131 in Subjects With Oral and Lung Cancers
Is NCT05893888 recruiting? Yes, currently enrolling (Sep 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) · PRV131 (Cisplatin Intratumoral Injectable) — 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 Arm 3 (Phase 1/2) PRV131: Intratumoral Injectable delivery into the Tumor Primary Endpoint: Safety and Objective Response Rate (ORR) Primary objective: Determine a safe and effective dose for PRV131 intratumoral injectable Subject Assignment: Subjects will be assigned to Arm 1, Arm 2, or Arm 3 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 Arm 3a: Histologically confirmed squamous cell carcinoma (SCC) of the oral cavity, classified as clinical stage T1-T3, N0-1, M0 Arm 3b: Histologically confirmed malignant tumor in the lungs (primary or secondary), classified as clinical stage T1-2, N0, M0
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage TIS, CIS
Tis/CIS of the lip or oral cavity; T1-T3, Nx,M0 of the lip or oral cavity; clinical stage T1-T3, N0-N1, M0; clinical stage T1-T2, N0, M0; Known bone involvement by the tumor (Stage T4) [excluded]
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: systemic chemotherapy for SCC of the head and neck
Exception: 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: radiotherapy for oral cavity SCC
Squamous cell carcinoma (SCC) of the oral cavity that received previous radiotherapy (Arm 1 only)
Cannot have received: platinum-based chemotherapy for oral cancers
Exception: nonresponsive to platinum-based chemotherapy within the past 12 months
History of oral cancers that were nonresponsive to radiation or platinum-based chemotherapy within the past 12 months (Arm 3a)
Cannot have received: platinum-based chemotherapy for lung cancers
Exception: nonresponsive to platinum-based chemotherapy within the past 12 months
History of cancers in the lung that were nonresponsive to radiation or platinum-based chemotherapy within the past 12 months (Arm 3b)
Lab requirements
Kidney function
Abnormal renal functions as determined by the investigator [excluded]
Liver function
Abnormal hepatic functions as determined by the investigator [excluded]
Cardiac function
Corrected QT interval (QTc) > 470 ms for women and > 450 ms for men [excluded]
Abnormal renal and hepatic functions as determined by the investigator [excluded]; Corrected QT interval (QTc) > 470 ms for women and > 450 ms for men [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope National Medical Center · Duarte, California
- Miami Cancer Institute · Miami, Florida
- The University of Chicago · Chicago, Illinois
- The Cleveland Clinic Foundation · Cleveland, Ohio
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 systemic chemotherapy for SCC of the head and neck, radiotherapy for oral cavity SCC, platinum-based chemotherapy for oral cancers 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