RecruitingPhase 1NCT04697576

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

Intralesional Influenza Vaccine for Patients With Melanoma

Sponsor

Carlo Contreras

Enrollment

36 participants

Start Date

Oct 20, 2021

Study Type

INTERVENTIONAL

Conditions

Clinical Stage IV Cutaneous Melanoma AJCC v8 Metastatic Melanoma 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

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

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether injecting an influenza (flu) vaccine directly into melanoma tumors can shrink them or trigger the immune system to fight the cancer. It is being tested in patients with stage I through IV melanoma. **You may be eligible if...** - You are 18 to 99 years old - You have been diagnosed with melanoma (stage I-III or stage IV) - You have at least one tumor that can be injected, measuring at least 1 cm - Your general health is reasonably good (ECOG performance status 0-2) **You may NOT be eligible if...** - You have a known allergy to the flu vaccine or its components - You have active autoimmune disease - You are on high-dose immune-suppressing medications - You have tumors that cannot be safely injected Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIpilimumab

immune checkpoint inhibitor

BIOLOGICALNivolumab

immune checkpoint inhibitor

BIOLOGICALPembrolizumab

immune checkpoint inhibitor

BIOLOGICALQuadrivalent 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).

PROCEDUREResection

Undergo surgical resection

BIOLOGICALNivolumab + Relatlimab

immune checkpoint inhibitor

Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT04697576

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