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<p>In this phase I study, we test a pooled synthetic long peptide vaccine targeting the six KRAS mutations (G12V, G12A, G12R, G12C, G12D, G13D) with ipilimumab and nivolumab in resected pancreatic adenocarcinoma. Co-primary endpoints include safety and maximal percent change of IFNγ-producing mutant KRAS T cell responses in the blood within 17 weeks. Secondary endpoints include disease-free survival, overall survival, and maximal percent change of IFNγ-producing mutant KRAS T cell responses at any time after vaccination. Vaccine-related adverse events are grade 1-2. 11/12 and 10/12 patients generate a significant increase in average T cell response to 6 mutant KRAS antigens and tumor-specific response, respectively. Immunophenotyping demonstrate Th1 CD4 central memory and effector memory T cells, and CD8 effector memory T cells at a lower frequency. The vaccine also generates cross-reactive T cells that recognize more than one mutant KRAS antigen. These findings support the safety and diverse anti-tumor immunity of mutant KRAS vaccines (NCT04117087).</p>

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Mutant KRAS vaccine with dual checkpoint blockade in resected pancreatic cancer: a phase I trial

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年2月10日

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  • Amanda L. Huff,
  • S. Daniel Haldar,
  • Alexander A. Girgis,
  • Hejia Henry Wang,
  • Ludmila Danilova,
  • Thatcher Heumann,
  • Maureen Berg,
  • Yuxuan Wang,
  • Lalitya Andaloori,
  • Alexei Hernandez,
  • Gabriella Longway,
  • Benjamin Barrett,
  • Zirui Zhu,
  • Emily Davis-Marcisak,
  • Christopher Thoburn,
  • James Leatherman,
  • Sarah Mitchell,
  • Jae W. Lee,
  • Daniel H. Shu,
  • Maximillian F. Konig,
  • Brian J. Mog,
  • Janelle Montagne,
  • Erin M. Coyne,
  • Katherine Bever,
  • Marina Baretti,
  • Mark Yarchoan,
  • Robert A. Anders,
  • Luciane T. Kagohara,
  • Daniel Laheru,
  • Amy M. Thomas,
  • Jennifer Durham,
  • Julie M. Nauroth,
  • Jiayun Lu,
  • Hao Wang,
  • Elana J. Fertig,
  • Won Jin Ho,
  • Nilofer S. Azad,
  • Elizabeth M. Jaffee,
  • Neeha Zaidi

摘要

In this phase I study, we test a pooled synthetic long peptide vaccine targeting the six KRAS mutations (G12V, G12A, G12R, G12C, G12D, G13D) with ipilimumab and nivolumab in resected pancreatic adenocarcinoma. Co-primary endpoints include safety and maximal percent change of IFNγ-producing mutant KRAS T cell responses in the blood within 17 weeks. Secondary endpoints include disease-free survival, overall survival, and maximal percent change of IFNγ-producing mutant KRAS T cell responses at any time after vaccination. Vaccine-related adverse events are grade 1-2. 11/12 and 10/12 patients generate a significant increase in average T cell response to 6 mutant KRAS antigens and tumor-specific response, respectively. Immunophenotyping demonstrate Th1 CD4 central memory and effector memory T cells, and CD8 effector memory T cells at a lower frequency. The vaccine also generates cross-reactive T cells that recognize more than one mutant KRAS antigen. These findings support the safety and diverse anti-tumor immunity of mutant KRAS vaccines (NCT04117087).