Details

Details

Title A Multicenter, Double-blind, Placebo-controlled, Adaptive Phase 3 Trial of POL-103A Polyvalent Melanoma Vaccine in Post-resection Melanoma Patients with a High Risk of Recurrence

IRB POLY1615

CC 15-1465

Hospital Fairview, Hillcrest, Independence, Main Campus

Phase Phase 3

Disease Melanoma

Drug POL-103A

Description

Description

Primary Objective
  • To assess the efficacy of treatment with seviprotimut-L compared to placebo with respect to recurrence-free survival and overall survival
Secondary Objectives
  • To verify the safety and tolerability of seviprotimut-L at the dose selected for Part B.
  • To assess a potential correlation between biomarker shifts/baseline prognostic markers and clinical outcome
Inclusion Criteria

Inclusion Criteria

  1. Histologically confirmed AJCC Stage IIB, IIC, or III cutaneous melanoma.
  2. Last definitive surgical resection of all clinically evident disease within 90 days prior to the first seviprotimut-L or placebo dosing. Subjects with positive margins of resection should have re-excision prior to randomization. Previous resections are acceptable, provided that the staging of the melanoma at the time of the previous resection was AJCC Stage I or IIA.
  3. Subjects with positive sentinel nodes must have a complete lymphadenectomy. Subjects randomized to the complete lymph node dissection then observation arm of the Multicenter Selective Lymphadenectomy Trial II (MSLT-II) are eligible for enrollment.
  4. Male or female subjects ≥ 18 and ≤ 80 years of age.
  5. Female subjects of childbearing potential must have a negative pregnancy test within 2 weeks prior to study randomization, must agree to use adequate contraception throughout the treatment duration and for 3 months after the last seviprotimut-L or placebo dosing, and must not be breastfeeding.
  6. ECOG Performance Status 0 or 1 and a reasonable expectation of living at least 2 years.
  7. White blood cell (WBC) count ≥ 4,000/mm3.
  8. Absolute neutrophil count ≥ 1,500/mm3.
  9. Hemoglobin ≥ 10 g/dL.
  10. Platelet count ≥ 100,000/mm3.
  11. Creatinine ≤ 2.0 mg/dL.
  12. Bilirubin ≤ 1.5 times the upper limit of normal (ULN).
  13. Asparate aminotransferase (AST), alanine aminotransferase (ALT) < 2.0 times ULN.
  14. Subjects must have known BRAF V600E mutation tumor status or have tumor tissue (fresh or archived sample) available for testing of BRAF V600E mutation status (note: as long as it is confirmed that tumor tissue is available for testing, the subject may be considered eligible for the study; testing of BRAF mutation status on that tissue may be conducted at a later time during the study).
Exclusion Criteria

Exclusion Criteria

  1. Any prior melanoma treatment other than surgery or regional irradiation (irradiation must be completed more than 2 weeks prior to first dose of study drug), including adjuvant or neoadjuvant treatment. (Subjects who received interferon alfa-2b with adjuvant treatment intent, but discontinued within 1 week of starting treatment, at least 60 days before first dose of study drug, will be allowed to enroll)
  2. Subjects who have a history of another malignancy within the past 5 years with the exception of adequately treated in situ squamous cell carcinoma, basal cell carcinoma, stage I or IIA melanoma, or carcinoma in situ of the cervix. See treatment exclusions noted within the other exclusion criteria.
  3. Use of biologic response modifiers (e.g., interleukin-2, colony-stimulating factors, other cytokines, BCG) within 60 days prior to first seviprotimut-L or placebo dosing.
  4. Chronic use of systemic corticosteroids (other than inhaled or nasal steroids) or other immunosuppressants, or subjects expected to require acute systemic steroids (Medrol dose pack or other oral steroids) during the 24-month treatment course.
  5. Known allergy to alum.
  6. Use of any investigational agents within 30 days prior to first seviprotimut-L or placebo dosing.
  7. History of any chronic medical or psychiatric condition or laboratory abnormality that, in the judgment of the investigator, may contraindicate study participation or study drug administration or may interfere with the interpretation of study results.
  8. Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures.
  9. Prior splenectomy.
  10. Known positivity for human immunodeficiency virus (HIV).
  11. Participants must not have or had prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. The following will not be exclusionary:
    • The presence of laboratory evidence of autoimmune disease without associated symptoms unless attending physician feels such symptoms are likely to arise within ninety (90) days of laboratory evidence.
    • Clinical evidence of vitiligo.
    • Other forms of depigmenting illness.
    • Mild arthritis requiring NSAID medications or no medical therapy.