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

• ClinicalTrials.gov Identifier: NCT03502148
• Recruitment Status: Completed
• First Posted: April 18, 2018
• Last Update Posted: November 24, 2021
• Sponsor: Privo Technologies
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Privo Technologies

Study Description

Brief Summary:

Up to 31 subjects diagnosed with oral squamous cell carcinoma will receive one application of a permeation enhancer and 2, 3, or 5 treatment applications of a Cisplatin drug-loaded patch to the tumor site at each of 4 treatment visits. These 4 treatment visits will be scheduled to occur during the 3 weeks prior to the standard of care tumor resection.

Funding Source: FDA OOPD

Condition or disease	Intervention/treatment	Phase
Oral Squamous Cell Carcinoma	Drug: PRV111 (Cisplatin Transmucosal System)	Phase 1; Phase 2

Detailed Description:

Up to 31 subjects diagnosed with oral squamous cell carcinoma will receive one application of a permeation enhancer and 2, 3, or 5 treatment applications of a Cisplatin drug-loaded patch to the tumor site at each of 4 treatment visits. These 4 treatment visits will be scheduled to occur during the 3 weeks prior to the standard of care tumor resection. After the surgery, subjects will be followed for 6 months for disease recurrence.

Ten subjects will be enrolled in Stage 1 of the study and will receive a permeation enhancer and 3 treatment applications of the cisplatin drug-loaded patch at each treatment visit. Up to 21 additional subjects will enroll in Stage 2 for the purpose of 16 total evaluable subjects at the final dose for the efficacy analysis. In Stage 2, the dose may be escalated, de-escalated, or remain the same based on the results in Stage 1. All subjects will be followed for 6 months post-surgery for disease recurrence.

During and at the conclusion of the treatment period, subjects will be monitored for local and systemic safety, tumor response due to the treatment, and systemic drug exposure.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Phase 1/2, Open-Label, Single-Arm
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 1/2, Open-Label, Single-Arm Safety and Efficacy Dose-Finding, Systemic Exposure, and Device Technical Effects of PRV111 (Cisplatin Transmucosal System) in Subjects With Oral Squamous Cell Carcinoma
• Actual Study Start Date: June 19, 2018
• Actual Primary Completion Date: October 27, 2019
• Actual Study Completion Date: May 6, 2020

Arms and Interventions

Arm

Intervention/treatment

Experimental: Open-Label, Single Arm Study of PRV111; In Stage 1, subjects will receive 3 treatment applications of PRV111 (Cisplatin Transmucosal System) at each of the 4 planned visits within 3 weeks prior to their tumor surgery. Following review of Stage 1 subject data, additional subjects will be enrolled in Stage 2 and will receive 2, 3 or 5 treatment applications dependent on the results of Stage 1 at each of the 4 visits prior to their tumor surgery.

Drug: PRV111 (Cisplatin Transmucosal System); Each treatment visit will include one application of a permeation enhancer and then 2, 3 or 5 PRV111 (Cisplatin Transmucosal System) applications depending on the Stage subject is enrolled in.

Outcome Measures

Primary Outcome Measures :

1. Determination of a safe and efficacious dose of PRV111 [ Time Frame: Subjects will be evaluated for safety and efficacy through study completion which is approximately 7 months. ]
   Based on the incidence of adverse events and tumor response

Secondary Outcome Measures :

1. Evaluate tumor volume shrinkage [ Time Frame: Assessed within the 21 days prior to surgical excision of the tumor ]
   Assessed by imaging at baseline and at the time of surgical excision
2. Assess long-term safety [ Time Frame: Assessed 1, 3 and 6 months post surgery ]
   Determine safety during post surgery follow-up visits by review of laboratory values and adverse events graded by CTCAE.
3. Evaluate systemic, tumor and lymph node (if available) platinum levels following PRV111 administration [ Time Frame: Assessed for 21 days from baseline through surgical excision of the tumor ]
   Assessed using bioanalytical methods
4. Evaluate device technical success including the residual cisplatin level in the patch after application [ Time Frame: Assessed during the 4 treatment visits in the 21 days prior to surgery ]
   Evaluate patch adhesion during application and residual cisplatin level post administration by bioanalytical methods.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Pathologically confirmed T1 (<2 cm) or T2 (>2 cm but < or = 4 cm) squamous cell carcinoma (SCC) of the lip or oral cavity (anterior 2/3 of the tongue, floor of mouth, lower and upper gingiva, salivary gland, hard palate, and buccal mucosa).
2. Tumor must be easily accessible, with no evidence of infection or active bleeding, encroaching major vessels or clinical evidence of neural invasion. Not previously irradiated.
3. Tumors must be amenable to surgical resection no later than 21 days post Visit 1.
4. Clinically or radiologically measurable tumor.
5. ECOG Performance Status of < or =2.
6. Adequate renal function as demonstrated by renal creatinine clearance.
7. Adequate organ function as assessed by safety labs.
8. Agree to use effective contraception for 30 days after the last dose of study drug.
9. Absence of any serious medical conditions that would impair the subject's ability to participate.
10. Willing and able to provide written informed consent.
11. Able to return to the study site for treatment and follow-up visits as defined in the protocol.

Exclusion Criteria:

1. Known distal metastasis of the SCC of the oral cavity.
2. Systemic chemotherapy for the treatment of SCC of the head and neck less than 2 years prior to screening.
3. Concurrent documented malignancy, with the exception of localized SCC of the skin.
4. Exposure to any investigational agent within 3 months prior to screening.
5. Known allergy or hypersensitivity to platinum-containing agents.
6. Active, uncontrolled infection requiring systemic therapy.
7. Known or suspected pregnancy, planned pregnancy or lactation.

Contacts and Locations

Locations

United States, Kentucky

Advanced ENT and Allergy

Louisville, Kentucky, United States, 40207

United States, Ohio

University of Cincinnati Cancer Institute

Cincinnati, Ohio, United States, 45267

United States, Texas

Ben Taub Hospital

Houston, Texas, United States, 77030

Memorial Hermann Hospital

Houston, Texas, United States, 77030

The University of Texas Health Science Center School of Dentistry

Houston, Texas, United States, 77054

Sponsors and Collaborators

Privo Technologies

National Cancer Institute (NCI)

Investigators

• Study Director: Manijeh Goldberg, PhD; CEO, Privo Technologies

More Information

• Responsible Party: Privo Technologies
• ClinicalTrials.gov Identifier: NCT03502148
• Other Study ID Numbers: CLN-001; FD-R-006325 ( Other Grant/Funding Number: FDA OOPD )
• First Posted: April 18, 2018
• Last Update Posted: November 24, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Neoplasms by Site; Cisplatin; Antineoplastic Agents