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  • Randomized Phase II study of the safety, efficacy and immune response of GVAX pancreas (with cyclophosphamide) and CRS-207 with or without nivolumab in patients with previously treated metastatic pancreatic adenocarcinoma (STELLAR)

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Randomized Phase II study of the safety, efficacy and immune response of GVAX pancreas (with cyclophosphamide) and CRS-207 with or without nivolumab in patients with previously treated metastatic pancreatic adenocarcinoma (STELLAR)
  1. Dung T Le1,
  2. Todd S Crocenzi2,
  3. Jennifer N Urum3,
  4. Eric R Lutz1,
  5. Daniel A Laheru3,
  6. Elizabeth A Sugar4,
  7. Robert H Vonderheide5,
  8. George A Fisher6,
  9. Andrew H Ko7,
  10. Aimee L Murphy8,
  11. Katherine McDougall9,
  12. Sandy Ferber10,
  13. Dirk G Brockstedt11 and
  14. Elizabeth M Jaffee1
  1. Aff1 grid.21107.350000000121719311The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore MD USA
  2. Aff2 grid.415337.7Providence Cancer Center Portland OR USA
  3. Aff3 grid.21107.350000000121719311The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore MD USA
  4. Aff4 grid.21107.350000000121719311Departments of Biostatistics and EpidemiologyJohns Hopkins Bloomberg School of Public Health Baltimore MD USA
  5. Aff5 grid.25879.310000000419368972University of Pennsylvania Baltimore MD USA
  6. Aff6 grid.168010.e0000000419368956Stanford University School of Medicine Stanford CA USA
  7. Aff7 grid.266102.10000000122976811UCSF Helen Diller Family Comprehensive Cancer Center San Francisco CA USA
  8. Aff8 grid.417411.6Aduro BioTech, Inc. Berkeley CA USA
  9. Aff9 grid.417411.6Aduro Biotech Berkeley CA USA
  10. Aff10 Array Biostatistics LLC Evanston IL USA
  11. Aff11 grid.417411.6Aduro Biotech, Inc. Berkeley CA USA

https://doi.org/10.1186/2051-1426-3-S2-P155

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    Meeting abstracts

    Background

    A heterologous prime-boost vaccination strategy using GVAX pancreas vaccine and CRS-207 is showing promise in patients with pancreatic adenocarcinoma (PDA) (Le, JCO 2015). Furthermore, blockade of the immune checkpoint programmed death-1 (PD-1) is active in some cancers. Combinatorial strategies aimed at priming tumor antigen-specific T cells while simultaneously blocking negative checkpoints may be necessary to improve outcomes in PDA. GVAX is composed of allogeneic pancreatic cancer cells modified to express GM-CSF and induces a broad response against multiple tumor antigens. GVAX is given with low-dose cyclophosphamide (CY) to inhibit regulatory T cells. CRS-207 is live-attenuated Listeria monocytogenes engineered to express the tumor-associated antigen mesothelin. CRS-207 boosts responses against mesothelin and is unique in its capacity to stimulate both innate and adaptive immunity by activating T cells and NK cells. Nivolumab is an antibody against PD-1.

    Methods

    This is a Phase II study comparing CY/GVAX and CRS-207 with or without nivolumab in subjects with PDA who failed only one chemotherapy regimen for metastatic disease. Subjects are randomized in a 1:1 ratio to receive either 2 doses of CY/nivolumab/GVAX and 4 doses of nivolumab/CRS-207 (Arm A) or 2 doses of CY/GVAX and 4 doses of CRS-207 (Arm B). The primary objective is to compare OS between Arms A and B. Secondary/exploratory objectives include: assessment of safety and clinical responses (tumor assessments and CA19-9 levels) and correlation of Lm- and mesothelin-specific T cell and other immunological responses with OS, progression-free survival and best overall response.