^
    8d
    A randomized phase II study: CRS207/GVAX plus anti-PD1 and anti-CTLA4 recruits mesothelin- and mKRAS-specific T cells into PDAC. (PubMed, Cancer Immunol Res)
    High myeloid and Treg signatures correlated with poor responses. We conclude that GVAX/CRS-207 plus nivolumab and ipilimumab successfully generates and expands T-cell clones specific to mesothelin and mutant KRAS within the PDAC TME but immunotherapy-induced myeloid-cell enrichment remains a barrier to greater efficacy.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • MSLN (Mesothelin)
    |
    KRAS mutation
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • CRS-207 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    9ms
    Study of CRS-207, Pembrolizumab, Ipilimumab, and Tadalafil in Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Apr 2025 --> Apr 2026
    Trial completion date
    |
    Keytruda (pembrolizumab) • Yervoy (ipilimumab) • CRS-207
    over1year
    Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer (clinicaltrials.gov)
    P2, N=41, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    STAT6 (Signal transducer and activator of transcription 6)
    |
    Keytruda (pembrolizumab) • cyclophosphamide • epacadostat (INCB024360) • CRS-207 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    over1year
    Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer (clinicaltrials.gov)
    P2, N=41, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2024 --> Aug 2024
    Trial completion date • Metastases
    |
    STAT6 (Signal transducer and activator of transcription 6)
    |
    Keytruda (pembrolizumab) • cyclophosphamide • epacadostat (INCB024360) • CRS-207 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    almost2years
    Study of CRS-207, Pembrolizumab, Ipilimumab, and Tadalafil in Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Apr 2025 | Trial primary completion date: Dec 2024 --> Apr 2024
    Enrollment closed • Trial completion date • Trial primary completion date • Metastases
    |
    Keytruda (pembrolizumab) • Yervoy (ipilimumab) • CRS-207
    2years
    Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer (clinicaltrials.gov)
    P2, N=40, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2023 --> Dec 2024
    Trial completion date • Metastases
    |
    STAT6 (Signal transducer and activator of transcription 6)
    |
    Keytruda (pembrolizumab) • cyclophosphamide • epacadostat (INCB024360) • CRS-207 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    almost3years
    Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer (clinicaltrials.gov)
    P2, N=61, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed --> Active, not recruiting | Trial completion date: Oct 2022 --> Aug 2023
    Enrollment closed • Trial completion date • Metastases
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • cyclophosphamide • CRS-207 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    3years
    Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer (clinicaltrials.gov)
    P2, N=40, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
    Trial completion date • Trial primary completion date • Metastases
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    Keytruda (pembrolizumab) • cyclophosphamide • epacadostat (INCB024360) • CRS-207 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    3years
    Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer (clinicaltrials.gov)
    P2, N=61, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • cyclophosphamide • CRS-207 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    over3years
    Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer (clinicaltrials.gov)
    P2, N=40, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    Keytruda (pembrolizumab) • cyclophosphamide • epacadostat (INCB024360) • CRS-207 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    almost4years
    Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer (clinicaltrials.gov)
    P2, N=44, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Mar 2023 --> Dec 2022 | Trial primary completion date: Mar 2023 --> Dec 2022
    Trial completion date • Trial primary completion date
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    Keytruda (pembrolizumab) • cyclophosphamide • epacadostat (INCB024360) • CRS-207 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    almost4years
    Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer (clinicaltrials.gov)
    P2, N=63, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Jul 2023 --> Sep 2022 | Trial primary completion date: Jul 2023 --> Sep 2022
    Trial completion date • Trial primary completion date
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • cyclophosphamide • CRS-207 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)