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

NCT04697576 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-03-10

No results posted yet for this 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.

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

Interventions

BIOLOGICAL

Quadrivalent Inactivated Influenza Vaccine

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).

PROCEDURE

Resection

Undergo surgical resection

BIOLOGICAL

Nivolumab + Relatlimab

immune checkpoint inhibitor

BIOLOGICAL

Ipilimumab

immune checkpoint inhibitor

BIOLOGICAL

Nivolumab

immune checkpoint inhibitor

BIOLOGICAL

Pembrolizumab

immune checkpoint inhibitor

Sponsors & Collaborators

  • Carlo Contreras

    lead OTHER

Principal Investigators

  • Carlo M Contreras, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-20
Primary Completion
2027-09-30
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04697576 on ClinicalTrials.gov