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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year after the last intra-tumoral dose

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year after the last intra-tumoral dose

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events (AEs)

Maximum tolerated dose (MTD) in Cohorts #1 and #2

Secondary outcome measures

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

11%

Injection Site Tenderness

10%

Headache

Injection Site Pain

Nausea

Malaise (Fatigue)

Preeclampsia

Vaginal Bleeding

Retroperitoneal hematoma

Spontaneous Abortion

ureterocele

Bladder outlet obstruction

Bilateral Subsegmental Pulmonary Embolism

Atrial septal defect

anomalous S1 hemivertebra

Sagittal Synostosis

Trisomy 21

ventricular septal defect

Ectopic kidney

Absent thyroid

Short femur

Vomiting

Retained Products of Conception

Shortness of Breath

Preterm Premature Rupture of Membranes (PPROM)

100%

80%

60%

40%

20%

Study treatment Arm

IIV4

RIV4

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

~2010

Ipilimumab

2014

Completed Phase 3

~2620

Nivolumab

2014

Completed Phase 3

~4750

Quadrivalent Inactivated Influenza Vaccine

2019

Completed Phase 4

~390

Resection

2021

Completed Phase 2

~410

0 / 4Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit of this clinical trial below 75 years?

"The qualifications for this trial stipulate that individuals participating must be between 18 and 90 years of age. In addition, there are 138 studies targeting patients younger than 18 and 2472 trials focusing on adults above the retirement threshold."

Answered by AI

Is recruitment for the trial still open?

"That is accurate. The information hosted on clinicaltrials.gov affirms that the trial, which was published on October 20th 2021, is still open for enrollment and searching to recruit 36 patients at one site."

Answered by AI

Have other investigations been conducted with Quadrivalent Inactivated Influenza Vaccine?

"Currently, there are 1686 clinical studies examining Quadrivalent Inactivated Influenza Vaccine with 204 in the most advanced stage of trials. Of these trials, the majority can be found in Houston, Texas; however, globally 74916 locations are trialing this vaccine."

Answered by AI

How many participants are taking part in the experiment?

"Affirmative, clinicaltrials.gov records demonstrate that this research study began on October 20th 2021 and is still recruiting participants. The team needs to fill 36 open spots at one facility."

Answered by AI

What condition is Quadrivalent Inactivated Influenza Vaccine most frequently employed to address?

"Quadrivalent Inactivated Influenza Vaccine (QIV) is typically used to treat unresectable melanoma, as well as other conditions such as microsatellite instability-high colorectal cancer and high risk of recurrence."

Answered by AI

Have the regulators sanctioned Quadrivalent Inactivated Influenza Vaccine?

"This Quadrivalent Inactivated Influenza Vaccine is still in its initial stages of testing, so our team assigned it a score of 1 to signify the limited data available on both safety and efficacy."

Answered by AI

What are the key aims of this clinical trial?

"The primary metric of this trial, which will be monitored over a two and half months period is the incidence of adverse effects. Secondary measures comprise degree of tumor reduction (percentage), Granzyme B H-score, and NanoString Pan Cancer Immune Profiling Panel; all three being assessed via summary statistics."

Answered by AI

Am I eligible to join this experiment?

"This trial is open to 36 qualified individuals aged 18-90 with a clinical stage iib cutaneous melanoma AJCC v8. To be eligible, they must also display an ECOG performance status of 0-1 and have at least one biopsy proven lesion measuring 1 cm or more."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Carlo Contreras 2021. "Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04697576.

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