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Chemotherapy

PRV211 for Oral Cancer

Phase 2 & 3

Recruiting

Research Sponsored by Privo Technologies

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Tumor must be amenable to surgical resection.

Candidates for standard of care treatment consisting of surgery.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-month post-surgery and through study completion, ~12-14 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called PRV211 that uses tiny particles to deliver chemotherapy directly to the tumor site during surgery. The goal is to kill any remaining cancer cells that couldn't be removed

Who is the study for?

Adults over 18 with a specific stage of oral cancer that can be surgically removed are eligible for this trial. They must have an ECOG Performance Status ≤2, indicating they're relatively able to carry out daily activities. Participants must agree to use two forms of birth control and not have any serious medical conditions that would affect their participation.

What is being tested?

The study is testing PRV211, a nano-engineered device delivering chemotherapy directly to the site of tumor removal in oral cancer surgery. The aim is to target any remaining cancer cells locally without affecting the rest of the body. Up to 40 patients will be monitored for safety and effectiveness.

What are the potential side effects?

Possible side effects aren't specified here, but generally, local chemotherapy may cause irritation or damage at the treatment site, pain, swelling, and could potentially lead to systemic issues like nausea or low blood counts if drugs enter circulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor can be removed with surgery.

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I am eligible for surgery as a standard treatment.

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I can take care of myself but might not be able to do heavy physical work.

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I am 18 years old or older.

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My cancer is in the early stages and located in my mouth or lip area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-month post-surgery and through study completion, ~12-14 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-month post-surgery and through study completion, ~12-14 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-month post-surgery and through study completion, ~12-14 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate (ORR)

Safety assessed via dose-limiting toxicities

Secondary study objectives

Event Free Survival

Pharmacokinetics: platinum levels in blood

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2: Pathologically proven and clinically confirmed T1-T3, Nx, M0 of the lip or oral cavityExperimental Treatment1 Intervention

Arm 2 PRV211 Intraoperative Locoregional Delivery Placed into the Resected Tumor Bed Primary Endpoint: Safety Primary Objective: Determine Safety of PRV211 in intraoperative setting

Group II: Arm 1: Pathologically proven and clinically confirmed Tis/CIS of the lip or oral cavityExperimental Treatment1 Intervention

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PRV111 (Cisplatin Transmucosal System)

2018

Completed Phase 2

~10

0 / 5Eligibility criteria met