Modified Virus VSV-IFNbetaTYRP1 in Treating Patients With Stage III-IV Melanoma

Stopped early · Phase 1

Conditions studied: Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Choroid Melanoma, Metastatic Melanoma, Metastatic Mucosal Melanoma, Metastatic Uveal Melanoma, Pathologic Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage IIIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8, Unresectable Melanoma

In brief

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.

Key facts

Study ID

NCT03865212

Run by

Mayo Clinic

People needed

12

Starts

2019-06-12

Expected to finish

2025-10-12

Last updated by the study team

2026-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 resolution of all previous treatment-related toxicities to grade 1 severity or lower
• Absolute neutrophil count (ANC) >= 1500/mm\^3 (obtained =< 14 days prior to registration)
• Platelet count >= 100,000/mm\^3 (obtained =< 14 days prior to registration)
• Hemoglobin >= 9.0 g/dL (without need for hematopoietic growth factor or transfusion support) (obtained =< 14 days prior to registration)
• Alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) (obtained =< 14 days prior to registration)
• Aspartate transaminase (AST) =< 2.5 x ULN (obtained =< 14 days prior to registration)
• Total bilirubin =< 1.5 x ULN (obtained =< 14 days prior to registration)
• Prothrombin time (PT) =< 1.5 x ULN (or international normalization ratio [INR] =< 1.4) or partial thromboplastin time (PTT)/activated partial thromboplastin time (aPTT) =< ULN (obtained =< 14 days prior to registration)
• Serum creatinine within institutional limits of normal (=< ULN) (obtained =< 14 days prior to registration)

You may not qualify if…

• Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
• Any of the following prior therapies:
• Prior chemotherapy =< 2 weeks prior to registration
• Prior immunotherapy (monoclonal antibodies) =< 3 weeks prior to registration
• Prior experimental agent =< 2 weeks prior to registration
• Prior radiation therapy =< 2 weeks prior to registration
• Need for concurrent chemotherapy, immunotherapy, radiotherapy, ablation therapy or any ancillary therapy considered investigational (used for a non-FDA approved indication or in the context of a research investigation)
• Minor surgical or interventional procedure =< 7 days prior to registration
• Major surgical procedure =< 21 days prior to registration
• History or evidence of melanoma associated with immunodeficiency states (e.g., hereditary immune deficiency, organ transplant, or leukemia, requires concomitant treatment with immunosuppressive agents, including CTLA-4 agonists, or chronic oral or systemic steroid medication including physiological replacement doses for adrenal insufficiency
• History of or plan for splenectomy or splenic irradiation
• History or evidence of central nervous system (CNS) metastases
• Active skin lesions (open wounds, severe rash, herpetic lesions, etc.)
• Prior non-oncology vaccine therapies used for the prevention of infectious disease =< 28 days prior to registration
• Requires concomitant treatment with therapeutic anticoagulants
• Known history of active tuberculosis
• Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
• Known acute or chronic hepatitis B or hepatitis C infection (requires negative test)
• Metastatic ocular melanoma patients only: liver radioembolization =< 90 days prior to registration
• No other active second malignancy other than non-melanoma skin cancers and in situ cervical cancers within 3 years of registration
• NOTE: A second malignancy is not considered active if all treatment for that malignancy is completed and the patient has been disease-free for at least 3 years prior to registration
• No uncontrolled intercurrent illness including, but not limited to:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris

Where it is running

• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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