Phase IIB TL + YCWP + DC in Melanoma
Public ClinicalTrials.gov record NCT02301611. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Randomized, Blinded, Placebo-controlled, Phase IIb Trial of an Autologous Tumor Lysate (TL) + Yeast Cell Wall Particles (YCWP) + Dendritic Cells (DC) Vaccine vs Unloaded YCWP + DC and Embedded Phase I/IIa Trial With Tumor Lysate Particle Only (TLPO) Vaccine in Stage III and Stage IV (Resected) Melanoma to Prevent Recurrence.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02301611
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 187 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2015 (Type not available)
- Primary completion
- May 11, 2022 (Actual)
- Completion
- May 11, 2022 (Actual)
- Last update posted
- Nov 29, 2024
2015 – 2022
United States locations
- U.S. sites
- 18
- U.S. states
- 15
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Birmingham (UAB) Comprehensive Cancer Center | Birmingham | Alabama | 35243 | — |
| Mayo Clinic - Cancer Clinical Research Office | Phoenix | Arizona | 85054 | — |
| The University of Arizona Cancer Center | Tucson | Arizona | 85724 | — |
| The Angeles Clinic and Research Institute A Cedars-Sinai Affiliate | Los Angeles | California | 90025 | — |
| John Wayne Cancer Institute | Santa Monica | California | 90404 | — |
| Mount Sinai Cancer Research Program | Miami Beach | Florida | 33140 | — |
| Northside Hospital Cancer Institute | Atlanta | Georgia | 30341 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | — |
| Mayo Clinic, Rochester | Rochester | Minnesota | 55905 | — |
| New Mexico Cancer Care Alliance | Albuquerque | New Mexico | 87102 | — |
| Laura and Isaac Permutter Cancer Center @ NYU Langone | New York | New York | 10016 | — |
| University of Cincinnati Cancer Institute | Cincinnati | Ohio | 45267 | — |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43202 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| St. Francis Hospital Cancer Center | Greenville | South Carolina | 29607 | — |
| Huntsman Cancer Institute/The University of Utah | Salt Lake City | Utah | 84112 | — |
| Providence Regional Medical Center Everett | Everett | Washington | 98201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02301611, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 29, 2024 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02301611 live on ClinicalTrials.gov.