← Back to Search

Virus Therapy

Modified Virus Therapy for Advanced Skin Cancer

Phase 1

Waitlist Available

Led By Roxana S Dronca

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

For cutaneous melanoma patients: at least one prior FDA approved systemic therapy in the metastatic setting and disease progression after immune checkpoint inhibitors

Injectable disease defined as at least 1 injectable and safely accessible cutaneous, subcutaneous, or nodal melanoma lesion >= 5 mm in longest diameter for metastatic cutaneous or mucosal melanoma

Must not have

History or evidence of melanoma associated with immunodeficiency states

Known history of active tuberculosis, HIV, acute or chronic hepatitis B or hepatitis C infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a modified virus that may help to treat patients with stage III-IV melanoma.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects aren't detailed here but may relate to how the body responds to the introduction of foreign genetic material designed to stimulate an immune response against cancer cells.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

Select...

I am 18 years old or older.

Select...

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

Select...

I am fully active or can carry out light work.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have melanoma and a weakened immune system.

Select...

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

Select...

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

Select...

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

Select...

My cancer has spread to my brain.

Select...

I do not have any uncontrolled illnesses or infections.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Maximum-tolerated dose

Secondary study objectives

Overall survival

Tumor response rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 13Eligibility criteria met