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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Carlo Contreras
Study ID
NCT04697576
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Clinical Stage I Cutaneous Melanoma AJCC v8
  • Clinical Stage IA Cutaneous Melanoma AJCC v8
  • Clinical Stage IB Cutaneous Melanoma AJCC v8
  • Clinical Stage II Cutaneous Melanoma AJCC v8
  • Clinical Stage IIA Cutaneous Melanoma AJCC v8
  • Clinical Stage IIB Cutaneous Melanoma AJCC v8
  • Clinical Stage IIC Cutaneous Melanoma AJCC v8
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Metastatic Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — BIOLOGICAL
    immune checkpoint inhibitor
  • Nivolumab — BIOLOGICAL
    immune checkpoint inhibitor
  • Pembrolizumab — BIOLOGICAL
    immune checkpoint inhibitor
  • Quadrivalent Inactivated Influenza Vaccine — BIOLOGICAL
    Given IM and intratumorally. For this protocol the U.S. F.D.A recently approved the use of recently expired influenza vaccine (only until new seasonal vaccine is available anticipated Sept 1). Use of expired vaccine will not exceed 4 months past June 30th expiry date (October 30th).
  • Resection — PROCEDURE
    Undergo surgical resection
  • Nivolumab + Relatlimab — BIOLOGICAL
    immune checkpoint inhibitor

Study Details

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.

Key Dates

Start date
Oct 20, 2021
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort I (resectable Stage I-III melanoma)
    Patients receive an influenza vaccine 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.
  • Experimental: Cohort II (unresectable Stage IV)
    Patients receive an 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 (single- or dual-agent) ipilimumab, nivolumab, relatlimab, or pembrolizumab.

Primary Outcome Measure

Incidence of adverse events (AEs) [ Time Frame: Up to 1 year after the last intra-tumoral dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Carlo M. Contreras, MD
[email protected]
614-366-3681
Carlo M. Contreras, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Columbus, OH

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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