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 Disease.
Completed · Phase 1/Phase 2
Conditions studied: Metastatic Melanoma
In brief
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.
Key facts
- Study ID
- NCT02678741
- Run by
- Elios Therapeutics, LLC
- People needed
- 26
- Starts
- 2016-02-01
- Expected to finish
- 2019-11-13
- Last updated by the study team
- 2024-03-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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)
Where it is running
- University of Alabama Birmingham Comprehensive Cancer Center — Birmingham, Alabama, United States
- John Wayne Cancer Institute/Providence Saint John's Health Center — Santa Monica, California, United States
- Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
- Northside Hospital — Atlanta, Georgia, United States
- University of Cincinnati Cancer Institute — Cincinnati, Ohio, United States
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
- Providence Regional Medical Center — Everett, Washington, United States
Full record on ClinicalTrials.gov
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