Randomized Trial of Tumor Lysate Particle Only Vaccine vs. Tumor Lysate Particle-Loaded, Dendritic Cell Vaccine to Prevent Recurrence of Resected Stage III/IV Melanoma: A 36-Month Analysis

Abstract

The tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine is created by loading dendritic cells (DCs) ex vivo with yeast cell wall particles (YCWP) with autologous tumor lysate (TL), producing a personalized vaccine. The autologous DCs are harvested either from a direct blood draw or a blood draw following the administration of granulocyte colony stimulating factor (G-CSF). Pre-treatment with G-CSF allows for smaller blood draw aliquots, but may affect the ability of autologous DCs The TLPLDC vaccine demonstrated improved 24-month DFS (62.9% vs.34.8%, p = 0.041) compared to placebo in a per-treatment (PT) analysis in phase IIb trials with 144 patients.1 The tumor lysate (TL) particle only (TLPO) vaccine utilizes a similar mechanism, but with autologous TL-loaded yeast cell wall particles(YCWP), thus reducing production time and cost by eliminating need for dendritic cell (DC) collection and ex vivo loading. The TLPO versus TLPLDC vaccine will be compared in an embedded bridging portion of the trial. We present 36-month outcomes of the ongoing randomized, double-blind phase 2 trial with resected stage III/IV melanoma, comparing patients receiving placebo (autologous DCs loaded with empty YCWP), TLPLDC with G-CSF (TLPLDC+G), TLPLDC without G-CSF (TLPLDC), and TLPO vaccines.

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Document Details

Document Type
Technical Report
Publication Date
Mar 15, 2022
Accession Number
AD1163535

Entities

People

  • Adam C. Berger
  • Alexander M. Adams
  • Ankur Tiwari
  • Anne E. O'shea
  • Annelies T. Hickerson
  • Diane F. Hale
  • Elizabeth L. Carpenter
  • Franklin A. Valdera
  • Guy T. Clifton
  • James W. Jakub
  • Jeffrey J. Sussman
  • Jessica L. Cindass
  • John Hyngstrom
  • John W. Iii Myers
  • Montaser Shaheen
  • Patrick M. Mccarthy
  • Philip M. Bohan
  • Robert C. Chick
  • Thomas Wagner
  • Timothy J Vreeland
  • Xianzhong Yu

Organizations

  • 59th Medical Wing

Tags

DTIC Thesaurus Topics

  • Air Force
  • Anatomy
  • Biological Sciences
  • Blood
  • Cells
  • Cellular Structures
  • Clinical Trials
  • Department Of Defense
  • Diseases And Disorders
  • Fungi
  • Melanoma
  • Neoplasms
  • New Brunswick
  • New Jersey
  • Particles
  • Survival
  • Therapy

Readers

  • Immunology
  • Oncology

Technology Areas

  • Biotechnology
  • Biotechnology - Cancer Biotech