Using an influenza vaccine to treat melanoma

Intralesional Influenza Vaccine for Patients With Melanoma

This study is testing whether an influenza vaccine can safely help people with melanoma, a type of skin cancer, by seeing how well it works to shrink tumors and improve their condition.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Ohio State University Comprehensive Cancer Center (other)
• Drugs / interventions: Nivolumab, Pembrolizumab, Ipilimumab, Relatlimab, prednisone
• Locations: 1 site (Columbus, Ohio)
• Trial ID: NCT04697576 on ClinicalTrials.gov

What this trial studies

This phase I trial evaluates the safety and tolerability of administering an intralesional quadrivalent inactivated influenza vaccine to patients with stage I-IV melanoma. The study aims to determine the maximum tolerated dose while assessing tumor dimensions and disease progression. It includes both resectable and metastatic melanoma patients, with a focus on immunological responses and tumor regression. The trial employs a dose-escalation design to optimize treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 99 with histologically confirmed cutaneous melanoma at clinical stages I-IV and a palpable tumor suitable for injection.

Not a fit: Patients with known allergies to influenza vaccination, active autoimmune diseases, or those requiring systemic immunosuppressive treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel immunotherapy option for patients with melanoma, potentially shrinking tumors and improving overall outcomes.

How similar studies have performed: While the use of intralesional vaccines is a novel approach in melanoma treatment, similar immunotherapy strategies have shown promise in other cancers, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* 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) \>= 9 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 Criteria:

* 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 this trial is running

Columbus, Ohio

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

Study contacts

• Principal investigator: Carlo M Contreras, MD — Ohio State University Comprehensive Cancer Center
• Study coordinator: The Ohio State University Comprehensive Cancer Center

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