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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

No Placebo-Only Group

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 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

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

Injection Site Pain

Injection Site Tenderness

Headache

Malaise (Fatigue)

Nausea

Preeclampsia

Opioid Dependence Relapse

Spontaneous Abortion

Vomiting

Congenital Fetal Cardiac Defect

Bilateral pyelectasis

Supernumerary Digit- Left Hand

Pyloric stenosis

Appendicitis

Infection

Hypertension

Chorioamnionitis

Volume Overload

Enterocolitis with abdominal abscess

Intrauterine Fetal Demise

100%

80%

60%

40%

20%

Study treatment Arm

RIV4

IIV4

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~3150

Ipilimumab

2015

Completed Phase 3

~3420