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

Recruiting now · Phase 1

Conditions studied: 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

In brief

This phase I trial investigates the effects of influenza vaccine in treating patients with stage I-IV melanoma. While intramuscular administration of influenza vaccine provides immunization against the influenza virus, giving influenza vaccine directly into the tumor (intralesional) may decrease the size of the injected melanoma tumor, or the extent of the melanoma within the body.

Key facts

Study ID

NCT04697576

Run by

Carlo Contreras

People needed

36

Starts

2021-10-20

Expected to finish

2027-12-31

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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