NCT04697576View on ClinicalTrials.gov

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

PHASE1RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

October 20, 2021

Primary Completion Date

February 5, 2026

Study Completion Date

December 31, 2026

Conditions
Clinical 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
Interventions
BIOLOGICAL

Ipilimumab

immune checkpoint inhibitor

BIOLOGICAL

Nivolumab

immune checkpoint inhibitor

BIOLOGICAL

Pembrolizumab

immune checkpoint inhibitor

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

Trial Locations (1)

43210

RECRUITING

Ohio State University Comprehensive Cancer Center, Columbus

All Listed Sponsors
lead

Carlo Contreras

OTHER