NCT04697576

Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma

Recruiting · Phase 1 · Carlo Contreras · registry updated 2026-07-13

Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.

This phase I trial investigates the effects of influenza vaccine in treating patients with stage I-IV melanoma. While intramuscular administration of influenza vaccine provides immunization against the influenza virus, giving influenza vaccine directly into the tumor (intralesional) may decrease the size of the injected melanoma tumor, or the extent of the melanoma within the body.

Inclusion

Males or females
to 99 years of age
Histologically confirmed cutaneous melanoma by historical pathology report review, clinical Stage I-III (Cohort #1), or Stage IV (Cohort #2) cutaneous melanoma
At least one, biopsy-proven, palpable melanoma tumor deposit suitable for intralesional injection measuring ≥ 1 cm by digital caliper (with digital photography documentation) or ultrasound (with ultrasound image documentation)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Absolute neutrophil count (ANC) \>= 1.5 x 10\^3/mm\^3 (drawn at or not more than 30 days prior to the screening visit)

Exclusion

Known allergy or intolerance to influenza vaccination
Subjects with condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone/equivalent) or other immunosuppressive medications within 14 days of study drug administration
Active, known or suspected autoimmune disease
Active brain metastasis or leptomeningeal metastasis
Diagnostic biopsy of ocular or mucosal melanoma
Any melanoma therapy within 6 months of enrollment; though prior surgical resection is permitted

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