Actively Recruiting

Phase 1
Age: 18Years - 99Years
All Genders
NCT04697576

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

Led by Carlo Contreras · Updated on 2026-03-10

36

Participants Needed

1

Research Sites

323 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 to 99 years
  • Histologically confirmed cutaneous melanoma, stage I-III for Cohort 1 or stage IV for Cohort 2
  • At least one biopsy-proven, palpable melanoma tumor of 1 cm or larger suitable for injection
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Adequate blood counts and organ function within 30 days prior to screening
  • Women of childbearing potential must use effective contraception during the study and specified follow-up periods
  • Women not of childbearing potential defined by menopause or surgical sterilization
  • Negative pregnancy test for women of childbearing potential
Not Eligible

You will not qualify if you...

  • Known allergy or intolerance to influenza vaccine
  • Need for systemic corticosteroids above 10 mg prednisone or other immunosuppressants within 14 days before study drug
  • Active or suspected autoimmune disease
  • Active brain or leptomeningeal metastases
  • Diagnosis of ocular or mucosal melanoma
  • Any melanoma therapy within 6 months except prior surgery
  • Incarcerated individuals
  • Pregnant or lactating women
  • Unable to provide informed consent
  • HIV positive patients not meeting stability and viral load criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

T

The Ohio State University Comprehensive Cancer Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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