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Virus Therapy

Flu Vaccine for Melanoma

Phase 1
Recruiting
Led By Carlo M Contreras, MD
Research Sponsored by Carlo Contreras
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
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)
Must not have
Active, known or suspected autoimmune disease
Patients incapable of independently providing consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year after the last intra-tumoral dose
Awards & highlights

Summary

This trial will give the flu vaccine to people with different stages of melanoma to see if it has any effect on the tumor size.

Who is the study for?
This trial is for adults aged 18-99 with stage I-IV cutaneous melanoma. Participants must have at least one palpable tumor deposit suitable for injection and be in good physical condition (ECOG PS 0-1). Exclusions include allergies to flu vaccines, recent immunosuppressants use, autoimmune diseases, ocular/mucosal melanoma, brain metastasis, recent melanoma therapy except surgery, incarceration, HIV positivity or pregnancy.
What is being tested?
The study tests if injecting the influenza vaccine directly into a melanoma tumor can reduce its size or spread. It's a phase I trial that also involves standard therapies like Ipilimumab and Nivolumab. Patients are grouped based on their cancer stage and receive either intralesional vaccine plus other treatments or those treatments alone.
What are the potential side effects?
Potential side effects may include typical flu shot reactions like soreness at the injection site but could also involve more serious immune responses due to the nature of cancer treatment drugs involved such as fatigue, skin issues or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I have a melanoma tumor that can be felt and measured to be at least 1 cm.
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I am between 18 and 99 years old.
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My skin cancer is confirmed as melanoma and is in an early or advanced stage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an autoimmune disease.
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I am unable to give consent on my own.
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I have active cancer spread to my brain or its coverings.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year after the last intra-tumoral dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year after the last intra-tumoral dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events (AEs)
Maximum tolerated dose (MTD) in Cohorts #1 and #2
Secondary study objectives
Biomarker analysis
Changes in micro ribonucleic acid (RNA) expression
Degree of tumor regression (percent)
+7 more

Side effects data

From 2021 Phase 4 trial • 384 Patients • NCT03969641
8%
Injection Site Pain
8%
Injection Site Tenderness
6%
Headache
6%
Malaise (Fatigue)
4%
Nausea
3%
Preeclampsia
1%
Opioid Dependence Relapse
1%
Spontaneous Abortion
1%
Vomiting
1%
Congenital Fetal Cardiac Defect
1%
Bilateral pyelectasis
1%
Supernumerary Digit- Left Hand
1%
Pyloric stenosis
1%
Appendicitis
1%
Infection
1%
Hypertension
1%
Chorioamnionitis
1%
Volume Overload
1%
Enterocolitis with abdominal abscess
1%
Intrauterine Fetal Demise
100%
80%
60%
40%
20%
0%
Study treatment Arm
RIV4
IIV4

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort II (unresectable Stage IV)Experimental Treatment5 Interventions
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.
Group II: Cohort I (resectable Stage I-III melanoma)Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070
Ipilimumab
2014
Completed Phase 3
~3140
Quadrivalent Inactivated Influenza Vaccine
2019
Completed Phase 4
~390
Nivolumab
2014
Completed Phase 3
~5220
Resection
2023
Completed Phase 2
~420

Find a Location

Who is running the clinical trial?

Carlo ContrerasLead Sponsor
Carlo M Contreras, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
3 Previous Clinical Trials
179 Total Patients Enrolled

Media Library

Quadrivalent Inactivated Influenza Vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04697576 — Phase 1
~9 spots leftby Sep 2025
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