Health Trials

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

ConditionsClinical Stage I Cutaneous Melanoma AJCC v8Clinical Stage IA Cutaneous Melanoma AJCC v8Clinical Stage IB Cutaneous Melanoma AJCC v8Clinical Stage II Cutaneous Melanoma AJCC v8Clinical Stage IIA Cutaneous Melanoma AJCC v8Clinical Stage IIB Cutaneous Melanoma AJCC v8Clinical Stage IIC Cutaneous Melanoma AJCC v8Clinical Stage IV Cutaneous Melanoma AJCC v8Metastatic Melanoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-99
SponsorCarlo Contreras

About this trial

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

Qualifiers

Males or females

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 ≥ 1 cm by digital caliper (with digital photography documentation) or ultrasound (with ultrasound image documentation)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ipilimumab
  • Nivolumab
  • Pembrolizumab
  • Quadrivalent Inactivated Influenza Vaccine
  • Resection
  • Nivolumab + Relatlimab

Treatment groups

36 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Carlo Contreras

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

Source ClinicalTrials.gov