Actively Recruiting
RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis
Led by Yana Najjar · Updated on 2026-04-13
25
Participants Needed
1
Research Sites
264 weeks
Total Duration
On this page
Sponsors
Y
Yana Najjar
Lead Sponsor
R
Replimune, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This early-phase study will examine Vusolimogene Oderparepvec, a genetically modified oncolytic viral strain of the herpes simplex type 1 (HSV-1) virus, with potential oncolytic, immunostimulating and antineoplastic activities. Upon administration, vusolimogene oderparepvec specifically targets, infects and replicates in tumor cells and does not infect healthy cells. This results in tumor cell lysis and the release of virus particles which infect and replicate within nearby tumor cells, resulting in tumor cel death. The immune system is activated by the released tumor-associated antigens (TAAs) from the tumor cells creating an anti-tumor immune response against the tumor cells, thereby further killing the tumor cells. The virus itself also elicits a tumor-specific systemic immune and cytotoxic T-lymphocyte (CTL) response, thereby killing nearby non-infected tumor cells.
CONDITIONS
Official Title
RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be willing and able to provide written informed consent for the trial.
- Be 18 years of age or older on the day of signing informed consent.
- Have a diagnosis of pT3b, T4a, or T4b melanoma on biopsy with grossly visible residual tumor or positive deep or lateral margin on initial biopsy.
- Females of childbearing potential must have negative pregnancy tests during screening and on treatment days.
- Female patients of reproductive potential must agree to use highly effective contraception until 90 days after last dose of RP1.
- Male patients of reproductive potential must agree to use highly effective contraception and refrain from donating sperm until 90 days after last dose of RP1.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Demonstrate adequate organ function with screening labs performed within 30 days of treatment initiation.
You will not qualify if you...
- Prior treatment with an oncolytic virus therapy.
- Have acute or chronic active hepatitis B or C virus infection, or HIV infection.
- Had systemic infection requiring IV antibiotics or other serious infection within 14 days prior to dosing.
- Have active significant herpetic infections or prior complications of HSV-1 infection.
- Require immunosuppressive doses (>10 mg daily prednisone or equivalent) of systemic corticosteroids other than for replacement therapy within 14 days after enrollment.
- Major surgery within 1 week prior to starting study drug without adequate recovery.
- Currently participating in or participated in an investigational agent or device study within 4 weeks prior to first dose.
- History of allergic or acute hypersensitivity reactions to RP1 or its excipients.
- Received a live vaccine within 30 days prior to first dose of study drug.
- History or current condition, therapy, or laboratory abnormality unfavorable for study drug administration or full participation.
- Serious or uncontrolled medical disorders.
- Known psychiatric, alcohol, or substance abuse disorders interfering with study cooperation.
- Person deprived of liberty by judicial or administrative decision or subject to legal protection.
- Solid organ transplant recipient.
- Concurrent malignancy requiring active systemic therapy or radiation.
- Tumors near critical structures or presenting with moderate to extensive bone erosion or invasion to critical structures unsuitable for injection.
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Trial Site Locations
Total: 1 location
1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
A
Amy Rose, RN, BSN
CONTACT
D
Danielle Bednarz, RN, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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