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    DRUG:

    GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)

    i
    Other names: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine , Pancreatic tumor cell vaccine/GM-CSF
    Associations

    News

    Trials
    Company:
    Novartis
    Drug class:
    GM-CSF agonist
    Related drugs:
    Associations

    News

    Trials
    28d
    Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov)
    P2, N=76, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial primary completion date: Oct 2025 --> May 2026
    Trial primary completion date • IO biomarker
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    Opdivo (nivolumab) • cyclophosphamide • BMS-986253 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • urelumab (BMS-663513)
    2ms
    Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas. (clinicaltrials.gov)
    P1/2, N=46, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Sep 2024 --> Feb 2025 | Trial primary completion date: Sep 2024 --> Feb 2025
    Trial completion date • Trial primary completion date
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    Opdivo (nivolumab) • BMS-813160 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    3ms
    Boost GVAX Pancreas Vaccine With or Without CY in Patients With Pancreas Cancer (clinicaltrials.gov)
    P2, N=71, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Aug 2025 --> Aug 2026
    Trial completion date
    |
    cyclophosphamide • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    4ms
    Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov)
    P2, N=76, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting --> Active, not recruiting
    Enrollment closed • IO biomarker
    |
    Opdivo (nivolumab) • cyclophosphamide • BMS-986253 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • urelumab (BMS-663513)
    5ms
    Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=38, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting --> Recruiting
    Enrollment open
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    KRAS (KRAS proto-oncogene GTPase)
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    cyclophosphamide • balstilimab (AGEN2034) • AGEN2373 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • Hiltonol (poly-ICLC) • KRAS peptide vaccine
    7ms
    A phase II study of neoadjuvant GVAX and cyclophosphamide combined with nivolumab and SBRT followed by surgery in borderline resectable pancreatic adenocarcinoma. (PubMed, Clin Cancer Res)
    The addition of combined immunotherapy and SBRT was safe and feasible in this patient population. No difference was observed in the mean CD8 T cell density between study patients and historical controls. These findings support the need for better characterization of how neoadjuvant immunotherapy may shift the phenotype of the PDAC TME.
    P2 data • Journal
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    CD8 (cluster of differentiation 8) • CSF2 (Colony stimulating factor 2)
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    Opdivo (nivolumab) • gemcitabine • albumin-bound paclitaxel • cyclophosphamide • irinotecan • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    8ms
    Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov)
    P2, N=76, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Aug 2026 --> May 2026
    Trial completion date • IO biomarker
    |
    Opdivo (nivolumab) • cyclophosphamide • BMS-986253 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • urelumab (BMS-663513)
    11ms
    Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=38, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    New P1/2 trial • IO biomarker
    |
    CD20 (Membrane Spanning 4-Domains A1)
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    cyclophosphamide • balstilimab (AGEN2034) • AGEN2373 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • Hiltonol (poly-ICLC) • KRAS peptide vaccine
    11ms
    The impact of KRAS mutations on the clinical outcome and immune response following immunotherapy for pancreatic cancer. (PubMed, Ann Pancreat Cancer)
    We identified a total of 30 patients from cohorts A: GVAX, an allogeneic whole cell cancer vaccine (n=16) and B: GVAX + anti-PD-1 (nivolumab) (n=14) with known KRAS mutation status and survival outcomes...With the addition of anti-PD-1 in Arm B, patients with KRAS G12D mutant disease had a lower ratio of CD8+ GZMB+/CD8+ T lymphocytes (P=0.005). KRAS G12D mutated PDAC represents a unique subtype of disease with decreased survival and lower ratio of activated CD8+ T lymphocytes as denoted by granzyme B (GZMB) positivity following GVAX/aPD-1 treatment.
    Clinical data • Journal • PD(L)-1 Biomarker • IO biomarker
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    KRAS (KRAS proto-oncogene GTPase) • CD8 (cluster of differentiation 8) • GZMB (Granzyme B)
    |
    KRAS mutation • KRAS G12C • KRAS G12D • KRAS wild-type • RAS wild-type • KRAS G12
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    Opdivo (nivolumab) • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    11ms
    CD137 agonism enhances anti-PD1 induced activation of expanded CD8+ T cell clones in a neoadjuvant pancreatic cancer clinical trial. (PubMed, iScience)
    Addition of CD137 agonist increased abundance of clonally expanded CD8+ T cells and increased immunosuppressive TREM2 signaling in tumor associated macrophages (TAMs), identified by comparison of ligand-receptor networks, corresponding to changes in metabolism and ECM interactions. These findings associate therapy with GVAX, anti-PD1, and CD137 agonist with enhanced CD8+ T cell function while inducing alternative immunosuppressive pathways in patients with PDAC.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • TNFRSF9 (TNF Receptor Superfamily Member 9) • CSF2 (Colony stimulating factor 2)
    |
    GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    12ms
    Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas. (clinicaltrials.gov)
    P1/2, N=46, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting --> Completed | N=30 --> 46 | Trial completion date: Dec 2024 --> Sep 2024 | Trial primary completion date: Dec 2024 --> Sep 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Metastases
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    TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    Opdivo (nivolumab) • BMS-813160 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    12ms
    Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov)
    P2, N=76, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2025 --> Aug 2026 | Trial primary completion date: Dec 2024 --> Aug 2025
    Trial completion date • Trial primary completion date • IO biomarker
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • TNFRSF9 (TNF Receptor Superfamily Member 9) • GZMB (Granzyme B) • IL17A (Interleukin 17A)
    |
    CD8 expression
    |
    Opdivo (nivolumab) • cyclophosphamide • BMS-986253 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • urelumab (BMS-663513)