Last updated on November 2019

Phase IIB TL + YCWP + DC in Melanoma


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: skin cancer | melanoma
  • Age: Between 18 - 99 Years
  • Gender: Male or Female

Inclusion Criteria:

  • 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status 0,1 (Appendix D)
  • AJCC stage III or IV completely resectable melanoma identified before surgery
  • Approximately 1 mg (1 cm3) of accessible and dispensable tumor that will not interfere with pathologic staging
  • Clinically disease-free after surgery
  • Completing SoC adjuvant therapy per NCCN guidelines to include chemotherapy, radiation therapy, and/or biologic therapy as clinically indicated. (Consent #2 should be signed as close to completion of SoC as possible but may overlap completion by up to one month.)
  • Vaccinations initiated between 3 weeks and 3 months from completion of SoC multi-modality cancer care
  • Adequate organ function as determined by the following laboratory values:
  • ANC 1,000/L
  • Platelets 75,000/L
  • Hgb 9 g/dL
  • Creatinine 1.5 x upper limit of normal (ULN) or Creatinine clearance 50%
  • Total bilirubin 1.5 ULN
  • ALT and AST 1.5 ULN
  • For women of child-bearing potential, agreement to use adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, oral contraception, IUD, or use of condoms or diaphragms)
  • Signed informed consent

Exclusion Criteria:

  • Evidence of residual disease after surgery and SoC adjuvant therapies
  • Insufficient tumor available to produce vaccine
  • ECOG >2 performance status (Appendix D)
  • Immune deficiency disease or known history of HIV, HBV, HCV
  • Receiving immunosuppressive therapy including chronic steroids, methotrexate, or other known immunosuppressive agents
  • Pregnancy (assessed by urine HCG)
  • Breast feeding
  • Active pulmonary disease requiring medication to include multiple inhalers (>2 inhalers and one containing steroids)
  • Involved in other experimental protocols (except with permission of the other study PI)

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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