Phase IIB TL + YCWP + DC in Melanoma
Summary
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.
Timeline
- Start
- 2015-01
- Primary completion
- 2022-05-11
- Completion
- 2022-05-11
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
paper While disease-free survival (DFS) was not different between groups in ITT analysis reads as missed primary endpoint PMID 33641012 ↗
release “The study met its primary endpoint by demonstrating a statistically significant reduction in the risk of disease recurrence at 24-months (disease-free survival; DFS)” reads as met primary endpoint eliostherapeutics.com ↗
release “In the PT analysis, 24-month DFS was significantly improved in the TLPLDC vaccine group compared to placebo” reads as met primary endpoint eliostherapeutics.com ↗
Publications
- Van Decar SG, Carpenter EL, Adams AM, Chick RC, Clifton GT, Stojadinovic A, Vreeland TJ, Valdera FA, Tiwari A, O'Shea AE, McCarthy PM, Hale DF, Bohan PMK, Hickerson AT, Cindass JL, Hyngstrom J, Berger AC, Jakub JW, Sussman JJ, Shaheen M, Yu X, Wagner T, Faries MB, Peoples GE. Tumor lysate particle only vaccine (TLPO) vs. Tumor lysate particle-loaded, dendritic cell vaccine (TLPLDC) to prevent recurrence in resected stage III/IV melanoma patients: Results of a phase I/IIa trial. Cancer Treat Res Commun. 2024;41:100843. doi: 10.1016/j.ctarc.2024.100843. Epub 2024 Sep 11.
- Carpenter EL, Van Decar S, Adams AM, O'Shea AE, McCarthy P, Chick RC, Clifton GT, Vreeland T, Valdera FA, Tiwari A, Hale D, Kemp Bohan P, Hickerson A, Smolinsky T, Thomas K, Cindass J, Hyngstrom J, Berger AC, Jakub J, Sussman JJ, Shaheen MF, Yu X, Wagner TE, Faries M, Peoples GE. Prospective, randomized, double-blind phase 2B trial of the TLPO and TLPLDC vaccines to prevent recurrence of resected stage III/IV melanoma: a prespecified 36-month analysis. J Immunother Cancer. 2023 Aug;11(8):e006665. doi: 10.1136/jitc-2023-006665.
- Vreeland TJ, Clifton GT, Hale DF, Chick RC, Hickerson AT, Cindass JL, Adams AM, Bohan PMK, Andtbacka RHI, Berger AC, Jakub JW, Sussman JJ, Terando AM, Wagner T, Peoples GE, Faries MB. A Phase IIb Randomized Controlled Trial of the TLPLDC Vaccine as Adjuvant Therapy After Surgical Resection of Stage III/IV Melanoma: A Primary Analysis. Ann Surg Oncol. 2021 Oct;28(11):6126-6137. doi: 10.1245/s10434-021-09709-1. Epub 2021 Feb 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TLPLDC | Vaccine | — | Other |