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Virus Therapy

Vusolimogene oderparepvec (RP1) for Melanoma

Q: Are potential participants currently able to join this research study?

<p>According to the information found on clinicaltrials.gov, this study is not currently seeking participants. The trial was first posted on January 31st, 2024 and last updated on January 11th, 2024. However, it's worth noting that there are presently 728 other ongoing clinical trials actively enrolling patients at the moment.</p>

Phase < 1

Recruiting

Led By Yana Najjar, MD

Research Sponsored by Yana Najjar

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Females of childbearing potential must have a negative beta-human chorionic gonadotropin (β-hCG) test with a minimum sensitivity of 25 IU/L or equivalent units of β-hCG during screening, before the first dose, and a negative urine pregnancy test on days of treatment (Day 1, 15 and 21). For serum and urine pregnancy tests and instructions (see Section 12.2)

Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing a genetically modified virus called Vusolimogene Oderparepvec. It is designed to specifically target and infect tumor cells, while leaving healthy cells unharmed. When

Who is the study for?

This trial is for individuals with primary melanoma, specifically to reduce the risk of cancer spreading to sentinel lymph nodes. Participants must meet certain health criteria not specified here.Check my eligibility

What is being tested?

The study tests Vusolimogene Oderparepvec (RP1), a modified herpes virus designed to target and kill melanoma cells while boosting the immune system's response against the tumor.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site, flu-like symptoms due to immune activation, and possible mild herpetic symptoms from the viral component.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant, as confirmed by sensitive blood and urine tests.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My melanoma is at an advanced stage but not in my eye.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of Sentinel Lymph Node (SLN) Positivity

Secondary outcome measures

Incidence of Serious Adverse Events (SAEs)

Incidence of all treatment-emergent adverse events (TEAEs)

Incidence of all treatment-emergent adverse events (TEAEs) requiring withdrawal from RP1

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Vusolimogene oderparepvec (RP1)Experimental Treatment1 Intervention

Patients will receive 3 doses of RP1 (1.0 mL/injection; 10e6 PFU/mL for the first dose, and 10e7 mL for the subsequent 2 doses). The drug will be injected into the skin at the tumor biopsy site at baseline (day 1), day 15, and day 21, 4-5 weeks prior to SOC WLE and SLNB. Definitive surgery will occur up to 28-35 (± 2 days) days from first injection, to avoid treatment delay.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yana NajjarLead Sponsor

5 Previous Clinical Trials

121 Total Patients Enrolled

5 Trials studying Melanoma

121 Patients Enrolled for Melanoma

Replimune Inc.Industry Sponsor

10 Previous Clinical Trials

1,310 Total Patients Enrolled

3 Trials studying Melanoma

805 Patients Enrolled for Melanoma

Yana Najjar, MDPrincipal InvestigatorUPMC Hillman Cancer Center

3 Previous Clinical Trials

82 Total Patients Enrolled

3 Trials studying Melanoma

82 Patients Enrolled for Melanoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants currently able to join this research study?

"According to the information found on clinicaltrials.gov, this study is not currently seeking participants. The trial was first posted on January 31st, 2024 and last updated on January 11th, 2024. However, it's worth noting that there are presently 728 other ongoing clinical trials actively enrolling patients at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis

Yana Najjar 2024. "RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06216938.

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