Phase IIB TL + YCWP + DC in Melanoma

Completed · Phase 2 · Has a placebo group

Conditions studied: Melanoma

In brief

The majority of melanoma vaccines tested to date have been antigen-specific vaccines targeting melanoma-specific or associated antigens and utilizing a variety of delivery systems and immune-adjuvants. As opposed to testing an "off the shelf" vaccine that might be able to treat a subset of patients, our approach has been personalized to the patient and applicable to all patients. Our vaccine approach consists of harnessing the most potent antigen presenting cell in the body - the dendritic cell (DC) - together with the full repertoire of tumor antigens from an individual's cancer. We have conducted phase I and II studies using an autologous DC-tumor cell fusion technique that has now been simplified into a DC-tumor cell lysate vaccine. The autologous tumor lysate (TL) is loaded into yeast cell wall particles (YCWP) that are naturally and efficiently taken up into the patient's DC. These autologous tumor lysate, particle-loaded, DC (TLPLDC) are injected intradermally (ID) monthly x 3 followed by boosters at 6, 12, and 18 months.

Key facts

Study ID

NCT02301611

Run by

Elios Therapeutics, LLC

People needed

187

Starts

2015-01-01

Expected to finish

2022-05-11

Last updated by the study team

2024-11-29

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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/μL
• Platelets ≥ 75,000/μL
• 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

You may not qualify if…

• 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)

Where it is running

• University of Alabama Birmingham (UAB) Comprehensive Cancer Center — Birmingham, Alabama, United States
• Mayo Clinic - Cancer Clinical Research Office — Phoenix, Arizona, United States
• The University of Arizona Cancer Center — Tucson, Arizona, United States
• The Angeles Clinic and Research Institute A Cedars-Sinai Affiliate — Los Angeles, California, United States
• John Wayne Cancer Institute — Santa Monica, California, United States
• Mount Sinai Cancer Research Program — Miami Beach, Florida, United States
• Northside Hospital Cancer Institute — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Memorial Hospital of South Bend — South Bend, Indiana, United States
• Mayo Clinic, Rochester — Rochester, Minnesota, United States
• New Mexico Cancer Care Alliance — Albuquerque, New Mexico, United States
• Laura and Isaac Permutter Cancer Center @ NYU Langone — New York, New York, United States
• University of Cincinnati Cancer Institute — Cincinnati, Ohio, United States
• The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• St. Francis Hospital Cancer Center — Greenville, South Carolina, United States
• Huntsman Cancer Institute/The University of Utah — Salt Lake City, Utah, United States
• Providence Regional Medical Center Everett — Everett, Washington, United States

Full record on ClinicalTrials.gov

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