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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
    13d
    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
    |
    TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    Opdivo (nivolumab) • BMS-813160 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    17d
    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)
    1m
    Phase I Study of Adjuvant Allogeneic GM-CSF-Transduced Pancreatic Tumor Cell Vaccine, Low Dose Cyclophosphamide, and SBRT followed by FFX in High-Risk Resected Pancreatic Ductal Adenocarcinoma. (PubMed, Int J Radiat Oncol Biol Phys)
    This is the first prospective trial to evaluate adjuvant GVAX, Cy, SBRT, and mFFX in resected PDAC patients with high-risk features. This combination regimen was well tolerated with limited toxicity and promising survival outcomes, warranting future studies to validate this regimen in the adjuvant setting.
    P1 data • Journal • Tumor cell
    |
    CSF2 (Colony stimulating factor 2)
    |
    5-fluorouracil • cyclophosphamide • irinotecan • leucovorin calcium • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    3ms
    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)
    4ms
    Pancreatic Tumor Cell Vaccine (GVAX), Cyclophosphamide, SBRT, and FOLFIRINOX in Patients With Resected Adenocarcinoma of the Pancreas (clinicaltrials.gov)
    P2, N=19, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active, not recruiting --> Completed | Phase classification: PN/A --> P2 | Trial completion date: Sep 2024 --> Oct 2023 | Trial primary completion date: Sep 2024 --> Oct 2023
    Trial completion • Phase classification • Trial completion date • Trial primary completion date • Tumor cell
    |
    5-fluorouracil • cyclophosphamide • oxaliplatin • irinotecan • leucovorin calcium • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    5ms
    A Trial of Boost Vaccinations of Pancreatic Tumor Cell Vaccine (clinicaltrials.gov)
    P2, N=71, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Aug 2024 --> Jul 2025
    Trial completion date • Tumor cell
    |
    cyclophosphamide • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    6ms
    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)
    10ms
    GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer (clinicaltrials.gov)
    P2, N=28, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active, not recruiting --> Completed | Trial completion date: Sep 2024 --> Feb 2024 | Trial primary completion date: Sep 2024 --> Feb 2024
    Trial completion • Trial completion date • Trial primary completion date • Combination therapy
    |
    CD8 (cluster of differentiation 8)
    |
    Opdivo (nivolumab) • cyclophosphamide • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    10ms
    Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas. (clinicaltrials.gov)
    P1/2, N=30, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    Opdivo (nivolumab) • BMS-813160 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    10ms
    Neoadjuvant radioimmunotherapy in pancreatic cancer enhances effector T cell infiltration and shortens their distances to tumor cells. (PubMed, Sci Adv)
    Adding SBRT to GVAX/a-PD-1 shortens the distances from PD-1+CD8+ T cells to tumor cells and to PD-L1+ myeloid cells, which portends prolonged survival. These findings have guided the design of next radioimmunotherapy studies by targeting M2-like TAM in PDACs.
    Journal • Tumor cell
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • GZMB (Granzyme B)
    |
    GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    11ms
    Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov)
    P1, N=12, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active, not recruiting --> Completed
    Trial completion • Combination therapy
    |
    Keytruda (pembrolizumab) • cyclophosphamide • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • LY3022855
    12ms
    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)
    1year
    A Trial of Boost Vaccinations of Pancreatic Tumor Cell Vaccine (clinicaltrials.gov)
    P2, N=71, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Aug 2023 --> Aug 2024 | Trial primary completion date: Aug 2023 --> Aug 2024
    Trial completion date • Trial primary completion date • Tumor cell
    |
    cyclophosphamide • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    over1year
    GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer (clinicaltrials.gov)
    P2, N=30, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Sep 2023 --> Sep 2024 | Trial primary completion date: Sep 2023 --> Sep 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    CD8 (cluster of differentiation 8)
    |
    Opdivo (nivolumab) • cyclophosphamide • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    over1year
    GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer (clinicaltrials.gov)
    P2, N=30, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Jun 2023 --> Sep 2023 | Trial primary completion date: Jun 2023 --> Sep 2023
    Trial completion date • Trial primary completion date • Combination therapy
    |
    CD8 (cluster of differentiation 8)
    |
    Opdivo (nivolumab) • cyclophosphamide • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    over1year
    A platform trial of neoadjuvant and adjuvant antitumor vaccination alone or in combination with PD-1 antagonist and CD137 agonist antibodies in patients with resectable pancreatic adenocarcinoma. (PubMed, Nat Commun)
    We enrolled patients with resectable pancreatic adenocarcinoma into such a platform trial (NCT02451982) to receive pancreatic cancer GVAX vaccine with low-dose cyclophosphamide alone (Arm A; n = 16), with anti-PD-1 antibody nivolumab (Arm B; n = 14), and with both nivolumab and anti-CD137 agonist antibody urelumab (Arm C; n = 10), respectively...GVAX+nivolumab+urelumab demonstrates numerically-improved disease-free survival (HR = 0.55, p = 0.242; HR = 0.51, p = 0.173) and overall survival (HR = 0.59, p = 0.377; HR = 0.53, p = 0.279) compared to GVAX and GVAX+nivolumab, respectively, although not statistically significant due to small sample size. Therefore, neoadjuvant and adjuvant GVAX with PD-1 blockade and CD137 agonist antibody therapy is safe, increases intratumoral activated, cytotoxic T cells, and demonstrates a potentially promising efficacy signal in resectable pancreatic adenocarcinoma that warrants further study.
    Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IL17A (Interleukin 17A)
    |
    Opdivo (nivolumab) • cyclophosphamide • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • urelumab (BMS-663513)
    over1year
    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: Jun 2024 --> Dec 2025 | Trial primary completion date: Jun 2023 --> Dec 2024
    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)
    |
    Opdivo (nivolumab) • cyclophosphamide • BMS-986253 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • urelumab (BMS-663513)
    almost2years
    Single-cell RNA and TCR sequencing of tumor infiltrating lymphocytes identifies changes in pancreatic ductal adenocarcinomas following neoadjuvant treatment with combined anti-PD-1 blocking and anti-CD137 agonist therapy (AACR 2023)
    We compared specimens from 3 treatment arms for downstream analysis: Arm A: an allogeneic whole cell vaccine, GVAX (n=7); Arm B: GVAX and nivolumab (n=4); Arm C: GVAX, nivolumab, and urelumab (n=4)... Analysis of combination GVAX, PD-1 inhibition and CD137 agonist therapy demonstrated changes in multiple immune cell proportions and their functional pathways. These data provide new evidence that PDACs can become T cell rich and respond to combination immunotherapies.
    Clinical • Tumor-infiltrating lymphocyte • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • ICAM1 (Intercellular adhesion molecule 1) • CCR7 (Chemokine (C-C motif) receptor 7)
    |
    CCR7 expresion
    |
    Opdivo (nivolumab) • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • urelumab (BMS-663513)
    almost2years
    GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer (clinicaltrials.gov)
    P2, N=30, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Jan 2023 --> Jun 2023 | Trial primary completion date: Jan 2023 --> Jun 2023
    Trial completion date • Trial primary completion date • Combination therapy
    |
    CD8 (cluster of differentiation 8)
    |
    Opdivo (nivolumab) • cyclophosphamide • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    almost2years
    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)
    almost2years
    Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas. (clinicaltrials.gov)
    P1/2, N=30, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Mar 2023 --> Dec 2023 | Trial primary completion date: Mar 2023 --> Dec 2023
    Trial completion date • Trial primary completion date • Metastases
    |
    TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    Opdivo (nivolumab) • BMS-813160 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    almost2years
    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)
    2years
    Nivolumab and a CCR2/CCR5 dual antagonist (BMS-813160) with or without GVAX for locally advanced pancreatic ductal adenocarcinomas: Results of phase I study. (ASCO-GI 2023)
    This open-label, single center two-arm phase I/II trial uses neoadjuvant/adjuvant nivolumab and BMS-813160 +/- GVAX following 8 to 16 doses of FOLFIRINOX and SBRT in patients with newly diagnosed LAPC... We determined that nivolumab 480mg IV q4 weeks, GVAX 5x108 cells intradermal q4 weeks, and BMS-813160 300mg PO BID were the RP2D for the phase 2 portion of this investigation which is ongoing. This combination appears safe and neoadjuvant use does not lead to delay in surgery. Clinical trial information: NCT03767582.
    P1 data • Metastases
    |
    CD8 (cluster of differentiation 8) • TNFRSF9 (TNF Receptor Superfamily Member 9) • CCR2 (C-C Motif Chemokine Receptor 2)
    |
    Opdivo (nivolumab) • 5-fluorouracil • irinotecan • leucovorin calcium • BMS-813160 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    2years
    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)
    2years
    Multi-omic analyses of changes in the tumor microenvironment of pancreatic adenocarcinoma following neoadjuvant treatment with anti-PD-1 therapy. (PubMed, Cancer Cell)
    Bulk and single-cell RNA sequencing found that nivolumab alters CD4 T cell chemotaxis signaling in association with CD11b neutrophil degranulation, and CD8 T cell expression of CD137 was required for optimal T cell activation. These findings provide insights into PD-1-regulated immune pathways in PDAC that should inform more effective therapeutic combinations that include TAN regulators and T cell activators.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • TNFRSF9 (TNF Receptor Superfamily Member 9) • ITGAM (Integrin, alpha M)
    |
    CD8 expression
    |
    Opdivo (nivolumab) • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    over2years
    Vaccine Therapy in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery (clinicaltrials.gov)
    P2, N=56, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial primary completion date: Dec 2022 --> Oct 2021
    Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase) • MSLN (Mesothelin) • CSF2 (Colony stimulating factor 2) • PSCA (Prostate Stem Cell Antigen 2)
    |
    KRAS mutation • RAS mutation
    |
    GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    over2years
    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)
    over2years
    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)
    over2years
    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)
    over2years
    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: Oct 2023 --> Jul 2023 | Trial primary completion date: Oct 2023 --> Jul 2023
    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)
    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=63, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • cyclophosphamide • CRS-207 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    almost3years
    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: Feb 2022 --> Mar 2023 | Trial primary completion date: Feb 2022 --> Mar 2023
    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)
    almost3years
    Vaccine Therapy in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery (clinicaltrials.gov)
    P2, N=56, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
    Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase) • MSLN (Mesothelin) • CSF2 (Colony stimulating factor 2) • PSCA (Prostate Stem Cell Antigen 2)
    |
    KRAS mutation
    |
    GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    almost3years
    Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas. (clinicaltrials.gov)
    P1/2, N=30, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Mar 2022 --> Mar 2023 | Trial primary completion date: Mar 2022 --> Mar 2023
    Trial completion date • Trial primary completion date
    |
    TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    Opdivo (nivolumab) • BMS-813160 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    almost3years
    Pancreatic Tumor Cell Vaccine (GVAX), Low Dose Cyclophosphamide, Fractionated Stereotactic Body Radiation Therapy (SBRT), and FOLFIRINOX Chemotherapy in Patients With Resected Adenocarcinoma of the Pancreas (clinicaltrials.gov)
    P=N/A, N=19, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2021 --> Sep 2024 | Trial primary completion date: Dec 2021 --> Sep 2024
    Trial completion date • Trial primary completion date
    |
    MSLN (Mesothelin)
    |
    5-fluorouracil • cyclophosphamide • oxaliplatin • irinotecan • leucovorin calcium • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    almost3years
    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 | Phase classification: P1/2 --> P2
    Clinical • Phase classification • 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)
    |
    Opdivo (nivolumab) • cyclophosphamide • BMS-986253 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • urelumab (BMS-663513)
    3years
    Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov)
    P1/2, N=76, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Feb 2023 --> Jun 2024 | Trial primary completion date: Jun 2022 --> Jun 2023
    Clinical • 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)
    |
    Opdivo (nivolumab) • cyclophosphamide • BMS-986253 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • urelumab (BMS-663513)
    over3years
    GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer (clinicaltrials.gov)
    P2, N=30, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed • Combination therapy
    |
    CD8 (cluster of differentiation 8)
    |
    Opdivo (nivolumab) • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
    over3years
    Pancreatic Tumor Cell Vaccine (GVAX), Low Dose Cyclophosphamide, Fractionated Stereotactic Body Radiation Therapy (SBRT), and FOLFIRINOX Chemotherapy in Patients With Resected Adenocarcinoma of the Pancreas (clinicaltrials.gov)
    P=N/A, N=19, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Aug 2021 --> Dec 2021 | Trial primary completion date: Aug 2021 --> Dec 2021
    Clinical • Trial completion date • Trial primary completion date
    |
    MSLN (Mesothelin)
    |
    5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • cyclophosphamide intravenous
    over3years
    Vaccine Therapy in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery (clinicaltrials.gov)
    P2, N=56, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Jul 2021 --> Dec 2021 | Trial primary completion date: Jul 2021 --> Dec 2021
    Clinical • Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase) • MSLN (Mesothelin) • CSF2 (Colony stimulating factor 2) • PSCA (Prostate Stem Cell Antigen 2)
    |
    KRAS mutation
    |
    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 | N=70 --> 44
    Clinical • Enrollment change
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    Keytruda (pembrolizumab) • epacadostat (INCB024360) • CRS-207 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • cyclophosphamide intravenous