NCT06623110 · Glenn J. Hanna
Phase II Study of RP2 as Immunoprevention in High-Risk Oral Precancerous Disease
(INTERCEPT)
What this study is about
The goal of this study is to understand the safety, tolerability, and potential effectiveness of an injected immune therapy called RP2 to treat taken by mouth precancer conditions and prevent progression to an taken by mouth cancer.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 ≥1 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
Where
- Boston, Massachusetts
Frequently asked questions
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.
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.
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.
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.
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.
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.
Data: ClinicalTrials.gov · synced Apr 23, 2026 · Source of record for eligibility and locations