Multi-center Phase I/IIa Trial of an Autologous Tumor Lysate (TL) + Yeast Cell Wall Particles (YCWP) + Dendritic Cells (DC) Vaccine in Addition to Standard of Care Checkpoint Inhibitor of Choice in Metastatic Melanoma Patients With Measurable Diseas

• Status: Completed
• Trial end date: 2019-11-13
• Target enrollment: 0
• Participant gender: All

Summary

Assess the safety and tumor response of utilizing an autologous tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine given in combination with standard of care (SoC) checkpoint inhibitors (CPI) in patients with stage IV melanoma with measurable disease.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Insight, LLC
• Collaborator: Elios Therapeutics, LLC
• Treatments: Vaccines

Criteria

Inclusion Criteria:

• 18 years or older

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Appendix A)

• Metastatic melanoma eligible for {or currently on} standard of care CPI therapy (treating physician's choice) with measurable disease.

• Approximately 1 cm3 preferred but 1 mg minimum of accessible and dispensable tumor (minimum of 3 passes with a core needle)

• Able to tolerate CPI treatment regimen {if already started}

• Adequate organ function as determined by the following laboratory values:

• ANC ≥ 1,000/μL

• Platelets ≥ 75,000/μL

• Hgb ≥ 9 g/dL

• Creatinine ≤ 1.5 x upper limit of normal (ULN) or Creatinine clearance ≥ 50% of lower limit of normal (LLN)

• 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)

Exclusion Criteria:

• Inability to tolerate CPI therapy {if already started}

• Rapidly progressing multi-focal metastatic melanoma

• Insufficient tumor available to produce vaccine

• ECOG >2 performance status (Appendix A)

• Immune deficiency disease or known history of HIV, HBV, HCV

• Receiving immunosuppressive therapy including chronic steroids (except physiologic maintenance doses), 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)