Modified Virus VSV-IFNbetaTYRP1 in Treating Patients With Stage III-IV Melanoma (NCT03865212) | Clinical Trial Compass
TerminatedPhase 1
Modified Virus VSV-IFNbetaTYRP1 in Treating Patients With Stage III-IV Melanoma
Stopped: Lack of funding; lack of objective response
United States12 participantsStarted 2019-06-12
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \>= 18 years
* Histologically or cytologically confirmed diagnosis of unresectable stage III or metastatic (stage IV) melanoma, including metastatic ocular melanoma
* Cutaneous melanoma patients only:
* At least one prior Food and Drug Administration (FDA) approved systemic therapy in the metastatic setting; and disease progression after immune checkpoint inhibitors
* If tumor is BRAF-mutated, previous BRAF- and/or MEK-targeted therapies are required
* NOTE: for ocular melanoma patients no current standard of care exists, so patients are permitted to be treated in 1st line setting
* Measurable disease by any imaging modality as defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)
* NOTE: disease that is measurable by physical examination only is not eligible
* Injectable disease (i.e., suitable for direct injection or through the use of ultrasound guidance) 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
* At least one safely accessible liver metastasis for patients with metastatic ocular melanoma
* Patients with metastatic ocular melanoma must meet all of the additional inclusion criteria:
* No more than 25% overall tumor involvement of the liver by magnetic resonance imaging (MRI) imaging
* Child Pugh Score A
* Absence of ascites
* No portal vein thrombosis
* Have re…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum-tolerated dose
Timeframe: Up to 28 days
2
Incidence of adverse events
Timeframe: Up to 42 days after treatment for Group A and 28 days after treatment for Group B