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

Last updated: October 6, 2024
Sponsor: Carlo Contreras
Overall Status: Active - Recruiting

Phase

1

Condition

Malignant Melanoma

Metastatic Melanoma

Melanoma

Treatment

Resection

Ipilimumab

Nivolumab + Relatlimab

Clinical Study ID

NCT04697576
OSU-20221
NCI-2020-13282
  • Ages 18-99
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 forintralesional injection measuring ≥ 1 cm by digital caliper (with digitalphotography documentation) or ultrasound (with ultrasound image documentation)

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

Exclusion

Exclusion Criteria:

  • 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 14days 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 resectionis permitted

  • Incarcerated patients

  • Human immunodeficiency virus (HIV) positive patients

  • Pregnant or lactating patients

  • Patients incapable of independently providing consent

Study Design

Total Participants: 36
Treatment Group(s): 6
Primary Treatment: Resection
Phase: 1
Study Start date:
October 20, 2021
Estimated Completion Date:
December 31, 2026

Study Description

PRIMARY OBJECTIVE:

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.

SECONDARY OBJECTIVES:

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)

EXPLORATORY OBJECTIVE:

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.

Connect with a study center

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

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