Could a virus injection stop oral cancer before it starts?
NCT ID NCT06623110
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new immune therapy called RP2, made from a modified herpes virus, to treat high-risk oral precancerous conditions and prevent them from turning into oral cancer. The therapy is injected directly into the lesion. The trial will enroll 25 people and look at safety, tolerability, and how well the lesions shrink or disappear.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RP2 (a genetically modified live herpes simplex virus-1 strain)
- What this could lead to
- If successful, this could provide a new way to prevent oral cancer in people with high-risk precancerous lesions.
- What could go wrong
- This is a small, early-phase trial (25 people) testing safety and effectiveness. The virus-based therapy may cause side effects, and it is not yet proven to prevent cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 of consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. * Participant must have normal marrow function and coagulation profile as defined within 21 days prior to study registration: * absolute neutrophil count ≥1,000/mcL * hemoglobin ≥9 g/dL * platelets ≥75,000/mcL, and (d) PT/INR \<2.5, and (e) aPTT \<1.5x ULN. * Women of childbearing potential (WOCBP) must agree to use appropriate method(s) of contraception. WOCBP and men should plan to use an adequate method to avoid pregnancy for 90 days after the last dose of RP2. WOCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Serum or urine BhCG testing is required within 24 hours of initial RP2 dosing. Exclusion Criteria: * Prior treatment with an oncolytic virus therapy. * Systemic infection requiring intravenous (IV) antibiotics. * Requires chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (e.g. acyclovir or valacyclovir). * Active significant herpetic infections or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis). Patients with sporadic cold sores may be enrolled provided they are asymptomatic at the time of starting RP2. * Known acute or chronic hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or acute or chronic hepatitis C virus (defined as HCV RNA \[qualitative\] is detected). Note: Patients who have been effectively treated are eligible for enrollment. Patients must be negative for HBsAg and HCV RNA. * Known human immunodeficiency virus (HIV) infection. Note: Testing for HIV is not required unless mandated by local health authority or clinically indicated. * A history of a prior stage III (T1-2N1, T3N0) or IV (T1-3N2, T4N0) invasive head \& neck squamous cell carcinoma treated with surgery and/or radiation with or without chemotherapy. * Patients cannot be on long-term (\>4 weeks) corticosteroids at doses exceeding prednisone 20 mg daily (or its equivalent) at the time of enrollment. * A personal history of hematopoietic stem cell (bone marrow) or solid organ transplant. * A personal history of other active malignancies, with exceptions including (but not limited to): non-melanomatous skin cancers, low-risk prostate adenocarcinoma on active surveillance, or treated cancers in remission for the last 2 years. * Significant bleeding event within the last 6 months that places the patient at risk for bleeding due to the injection procedure based on Investigator assessment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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Dana-Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02115, United States