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NCT06623110RECRUITINGIRB Ready

Phase II Study of RP2 as Immunoprevention in High-Risk Oral Precancerous Disease

(INTERCEPT)

Sponsored by Glenn J. Hanna

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 25 participants interested
4% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The goal of this study is to understand the safety, tolerability, and potential efficacy of an injected immune therapy called RP2 to treat oral precancer conditions and prevent progression to an oral cancer.

Who Can Participate

Inclusion Criteria

Patients with a diagnosis of high-risk OPD defined by any of the following:
Proliferative leukoplakia (PL)
Localized leukoplakia showing at least moderate dysplasia not treated with surgery
Erythroplakia (regardless of dysplasia)
High-risk LOH profile: 9p21 or CDKN2A or MTAP loss; regardless of personal oral cancer history
Any degree of dysplasia with a known TP53 mutation
A history of treated stage 1 or 2 (AJCC 2017 8th edition) HNSCC with at least moderate dysplasia at the resection margins or known 9p21 loss or a known TP53 mutation
No evidence of head and neck cancer recurrence within the last 3 months (if applicable).
Willing to provide blood and tissue for diagnostic biopsies.
At least one target injectable measurable lesion โ‰ฅ1 cm in longest diameter that can be followed.
Any smoking history is permitted. While discouraged, patients are permitted to continue tobacco use while on the study.
Age 18 years or older at the time

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

25 participants

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Gender

ALL

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Sponsor

Glenn J. Hanna

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Boston

Massachusetts

Location available
View Boston location page
RECRUITING

Boston

Massachusetts

Location available
View Boston location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Oral Precancer Treatment in Boston?

Join others in Massachusetts exploring innovative treatment options through clinical research

Oral Precancer Treatment Options in Boston, Massachusetts

If you're searching for Oral Precancer treatment in Boston, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Boston, Boston and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Oral Precancer. All study-related care is provided at no cost to participants.

Local Sites
2 locations in Massachusetts
Now Enrolling
Up to 25 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Oral Precancer?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Oral Precancer

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Oral Precancer Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06623110. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.