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

ConditionHigh-Risk Oral Precancerous Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlenn J. Hanna

About this trial

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.

The name of the study drug involved in this study is:

-RP2 (a genetically modified live Herpes Simplex V-1 strain)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • RP2 Injection

    Biological/Vaccine

    Genetically modified live HSV-1 virus, 3.0 mL single-use glass vials, via intralesional (into a lesion) injection per protocol.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: RP2 InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Best Overall Response

The best overall response is the best response recorded from the start of the treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Responses do not require confirmation. Complete response (CR) is complete disappearance of all target lesions. Partial response (PR) is at least 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Time frame
Up to 1 year

Secondary outcomes

1

Adverse Event Rate

Adverse event rate is defined as the proportion of participants experiencing adverse. Adverse events will be classified and graded according to CTCAE5.0.

Time frame
Up to 1 year
2

Median Cancer-free Survival (CFS)

Cancer-Free Survival (CFS) is defined as the time from study registration to development of a biopsy-proven invasive oral cancer (oral squamous cell carcinoma or OSCC) or time to a primary, recurrent, or secondary biopsy-proven invasive head and neck cancer diagnosis (squamous cell carcinoma of the head and neck) or death due to any cause. Participants alive without disease progression or recurrence (of invasive oral cancer) are censored at date of last disease evaluation.

Time frame
Up to 1 year
3

Median Overall Survival (OS)

Overall Survival (OS) based on Kaplan-Meier method is defined as the time from registration to death due to any cause, or censored at date last known alive.

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Glenn J. Hanna

Lead sponsor

Dana-Farber Cancer Institute

Sponsor institution

Replimune, Inc.

Collaborator

Source ClinicalTrials.gov
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