Modified Virus Therapy for Advanced Skin Cancer

Palo Alto (17 mi)

Overseen byRoxana S Dronca

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?This phase I trial studies the side effects and best dose of a modified virus called VSV-IFNbetaTYRP1 in treating patients with stage III-IV melanoma. The vesicular stomatitis virus (VSV) has been altered to include two extra genes: human interferon beta (hIFNbeta), which may protect normal healthy cells from becoming infected with the virus, and TYRP1, which is expressed mainly in melanocytes (specialized skin cell that produces the protective skin-darkening pigment melanin) and melanoma tumor cells, and may trigger a strong immune response to kill the melanoma tumor cells.

Eligibility Criteria

This trial is for adults over 18 with stage III-IV melanoma, including ocular melanoma. Participants must have tried FDA-approved systemic therapy and progressed after immune checkpoint inhibitors. For those with BRAF mutations, prior targeted therapies are needed. They should have at least one injectable tumor lesion and a life expectancy of 12+ weeks. Contraception use is required during the study and for 120 days after.

Inclusion Criteria

I have skin cancer that worsened after treatment with specific immune drugs.

I have a melanoma spot or node that can be injected and is at least 5 mm big.

I am 18 years old or older.

My melanoma cannot be removed by surgery and has spread to other parts.

I am fully active or can carry out light work.

I have had treatments targeting BRAF or MEK for my melanoma.

Exclusion Criteria

I have melanoma and a weakened immune system.

I have a history of tuberculosis, HIV, or hepatitis B/C.

There is a known treatment that could cure or extend my life.

I have had liver radioembolization for ocular melanoma within the last 90 days.

My cancer has spread to my brain.

I do not have any uncontrolled illnesses or infections.

I have had or am planning to have surgery or radiation on my spleen.

Treatment Details

The trial tests a modified virus called VSV-IFNbetaTYRP1 on patients with advanced melanoma to see if it's safe and what dose works best. The virus has been changed to include genes that might protect healthy cells and help the immune system attack melanoma cells.

2Treatment groups

Experimental Treatment

Group I: Group B (VSV-IFNbetaTYRP1)Experimental Treatment1 Intervention

Patients receive recombinant vesicular stomatitis virus-expressing interferon-beta and tyrosinase related protein 1 IT and IV over 30-60 minutes 2-4 hours later on day 1. Cycle 1 continues for 28 days, with subsequent cycles repeating every 21 days in the absence of disease progression or unacceptable toxicity.

Group II: Group A (VSV-IFNbetaTYRP1)Experimental Treatment1 Intervention

Patients receive recombinant vesicular stomatitis virus-expressing interferon-beta and tyrosinase related protein 1 IT and IV over 30-60 minutes 2-4 hours later on day 1.