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Influenza Vaccine for Melanoma Treatment

This study is looking at how safe and effective an influenza (flu) vaccine is when given directly into melanoma tumors (intralesional) for people with Stage I-IV melanoma. Researchers want to see if injecting the flu vaccine into the tumor can shrink it or stop the cancer from spreading. Some participants will receive the flu vaccine alone, while others will receive it along with standard melanoma treatments like Ipilimumab, Nivolumab, or Pembrolizumab, which are immune checkpoint inhibitors (medicines that help your immune system fight cancer). The study aims to find the highest safe dose of the flu vaccine and measure how well it reduces tumor size. You may be able to join if you are 18 to 99 years old and have a melanoma tumor that can be injected.

Study design
This is an interventional study with a planned enrollment of 36 participants. It is designed to evaluate the safety and maximum tolerated dose of the influenza vaccine.
What's involved
You would undergo surgical removal of your tumor (resection) and receive injections of the influenza vaccine, either alone or with other cancer medications. The study will monitor for side effects and measure tumor size.
Compensation
Not stated in the trial record.
Follow-up
Your adverse events will be measured for up to 1 year after your last intra-tumoral dose of the vaccine.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04697576

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

Recruiting
PHASE1Ages 18–99InterventionalTreatment
Carlo Contreras
~36 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:IpilimumabNivolumabPembrolizumabQuadrivalent Inactivated Influenza VaccineResectionNivolumab + Relatlimab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs)
Measured over Up to 1 year after the last intra-tumoral dose
+1 more outcome measured

Conditions

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
Clinical Stage IV Cutaneous Melanoma AJCC v8
Metastatic Melanoma

Explore related trials

Cutaneous Melanoma

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Carlo M Contreras, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

The Ohio State University Comprehensive Cancer Center
[email protected]
800-293-5066
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Males or females
18 to 99 years of age
Histologically confirmed cutaneous melanoma by historical pathology report review, clinical Stage I-III (Cohort #1), or Stage IV (Cohort #2) cutaneous melanoma
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)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Absolute neutrophil count (ANC) \>= 1.5 x 10\^3/mm\^3 (drawn at or not more than 30 days prior to the screening visit)
Hemoglobin (Hgb) \>= 8 g/dL (drawn at or not more than 30 days prior to the screening visit)
Platelet count \>= 100 x 10\^3/mm\^3 (drawn at or not more than 30 days prior to the screening visit)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) or =\< 5 x ULN in patients with liver metastases (Cohort 2 only) (drawn at or not more than 30 days prior to the screening visit)
Prothrombin time =\< 1.5 x ULN (drawn at or not more than 30 days prior to the screening visit)
Total bilirubin =\< 1.5 x ULN (unconjugated bilirubin of \< 3 x ULN for patients with known Gilbert syndrome) (drawn at or not more than 30 days prior to the screening visit)
Creatinine clearance of \>= 50 ml/min by Cockcroft-Gault equation (drawn at or not more than 30 days prior to the screening visit)
Women of childbearing potential (WOCBP) must agree to use effective contraceptive methods from screening until at least:
Cohort 1: 14 days after the surgical resection for subjects in Cohort 1
Cohort 2:
Nivolumab: 5 months after the last dose of either nivolumab or intralesional Flucelvax, whichever is later
Pembrolizumab: 4 months after the last dose of either pembrolizumab or intralesional Flucelvax, whichever is later
Ipilimumab: 3 months after the last dose of either ipilimumab or intralesional Flucelvax, whichever is later
Relatlimab + nivolumab (marketed under the trade name Opdualag): 5 months after the last dose of either Opdualag or intralesional Flucelvax, whichever is later.
Combination ipilimumab with other checkpoint inhibitor: Whichever is later:
3 months after the last dose of either ipilimumab or intralesional Flucelvax
Above-bulleted recommendation for nivolumab or pembrolizumab
Non-childbearing potential is defined as a woman who meets either of the following criteria: a) postmenopausal state defined as no menses for 12 months without an alternative medical cause, or b) documented hysterectomy, bilateral tubal ligation, or bilateral oophorectomy
Effective contraception methods are defined as one of the following:
True abstinence, defined as refraining from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject
Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception
Condoms and spermicide
Diaphragm and spermicide
Oral or implanted hormonal contraceptive
An intra-uterine device
WOCBP must have a negative pregnancy test (serum or urine)

Exclusion

Known allergy or intolerance to influenza vaccination
Subjects with condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone/equivalent) or other immunosuppressive medications within 14 days of study drug administration
Active, known or suspected autoimmune disease
Active brain metastasis or leptomeningeal metastasis
Diagnostic biopsy of ocular or mucosal melanoma
Any melanoma therapy within 6 months of enrollment; though prior surgical resection is permitted
Incarcerated patients
Patients known to be HIV positive are eligible if they meet the following criteria within 30 days prior to randomization: stable and adequate CD4 counts (≥ 350 mm\^3), and serum HIV viral load of \< 25,000 IU/ml. Patients may be on or off anti-viral therapy so long as they meet the CD4 count criteria
Pregnant or lactating patients
Patients incapable of independently providing consent

What this trial measures

  • Incidence of adverse events (AEs)Up to 1 year after the last intra-tumoral dose

    Frequency and severity of AEs and tolerability of the regimen will be collected and summarized by descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. All patients who have received at least one dose of the therapeutic agents will be evaluable for toxicity and tolerability.

  • Maximum tolerated dose (MTD) in Cohorts #1 and #2Up to 98 days

    Will employ the Bayesian optimal interval design to find the MTD.