Status:
RECRUITING
Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma
Lead Sponsor:
Carlo Contreras
Conditions:
Clinical Stage I Cutaneous Melanoma AJCC v8
Clinical Stage IA Cutaneous Melanoma AJCC v8
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
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 th...
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate the safety and tolerability and determine the maximum tolerated dose of intralesional (quadrivalent inactivated influenza vaccine (unadjuvanted influenza vaccine) fo...
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) \>= 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
- 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
Key Trial Info
Start Date :
October 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04697576
Start Date
October 20 2021
End Date
December 31 2026
Last Update
July 30 2025
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210