Melanoma Clinical Trial
Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma
This phase I trial investigates the effects of influenza vaccine in treating patients with stage I, II, and 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.
I. To evaluate the safety and tolerability and determine the maximum tolerated dose of intralesional (quadrivalent inactivated influenza vaccine (unadjuvanted influenza vaccine) for patients with a) resectable melanoma as monotherapy, and b) metastatic melanoma, concurrent with standard of care (single- or dual-agent) checkpoint inhibition.
I. To evaluate tumor dimensions of injected (Cohorts #1-2) and non-injected lesions (Cohort #2 only), by caliper or ultrasound measurement. (Clinical endpoint) II. To determine time to disease progression (local or distant). (Clinical endpoint) III. To evaluate immunohistochemistry density, cells/mm^2: CD4, CD8, PD-L1, PD1, CD56, CD20, CD45RO, FOXP3. (Tumor-based endpoint) IV. To evaluate granzyme B H-score. (Tumor-based endpoint) V. To evaluate NanoString Pan Cancer Immune Profiling Panel. (Tumor-based endpoint) VI. To evaluate tumor-infiltrating lymphocytes: not identified, present (non-brisk), present (brisk), cannot be determined. (Tumor-based endpoint) VII. To evaluate degree of tumor regression (percent). (Tumor-based endpoint) VIII. To evaluate changes in micro ribonucleic acid (microRNA) expression. (Tumor-based endpoint) IX. To evaluate of flow cytometry for T-cell subset evaluation and changes in circulating microRNA. (Blood draw endpoint)
I. To evaluate the evidence of immunologic activation in blood and tissue specimens.
OUTLINE: This is dose-escalation study. Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients receive quadrivalent inactivated influenza vaccine intramuscularly (IM) on day 0 and intratumorally on days 2 and 14 in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery on day 28.
COHORT II: Patients receive quadrivalent inactivated influenza vaccine IM on day 0 and intratumorally on days 2, 14, 28, 42, 56, 70, 84, and 98 in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care ipilimumab, nivolumab, pembrolizumab, or Opdualag.
After completion of study treatment, patients are followed up for up to 1 year.
18 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 â‰¥ 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
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
Human immunodeficiency virus (HIV) positive patients
Pregnant or lactating patients
Patients incapable of independently providing consent
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