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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
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Company:
Novartis
Drug class:
GM-CSF agonist
Related drugs:
3ms
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)
3ms
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)
3ms
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)
4ms
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
4ms
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)
7ms
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)
8ms
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)
10ms
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)
11ms
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)
1year
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)
1year
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)
1year
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)
1year
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)
over1year
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)
over1year
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)
over1year
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)
over1year
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)
over1year
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)
almost2years
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)
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 | 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)
2years
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)
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=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)
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=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)
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=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)
2years
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)
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 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)
over2years
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)
over2years
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)
over2years
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)
over2years
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)
over2years
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)
over2years
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)
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 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)
3years
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)
over3years
Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer (clinicaltrials.gov)
P2, N=70, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Jun 2023 --> Feb 2022 | Trial primary completion date: Feb 2021 --> Feb 2022
Clinical • Trial completion date • Trial primary completion date
|
CA 19-9 (Cancer antigen 19-9)
|
Keytruda (pembrolizumab) • epacadostat (INCB024360) • CRS-207 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
almost4years
Adding combination immunotherapy consisting of cancer vaccine, anti-PD-1 and anti-CSF1R antibodies to gemcitabine improves anti-tumor efficacy in murine model of pancreatic ductal adenocarcinoma. (PubMed, Ann Pancreat Cancer)
Gemcitabine with GVAX and anti-PD1 with or without anti-CSF-1R also improved the infiltration of effector CD8+ T-cells, and the presence of anti-CSF-1R in the chemo-immunotherapy regimens decreased the infiltration of myeloid cells. The overlapping mechanisms of the components in the chemo-immunotherapy regimens may explain the lack of survival difference between the various regimens, and this remains to be explored.
Preclinical • Journal • PD(L)-1 Biomarker
|
CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CSF1R (Colony stimulating factor 1 receptor)
|
CD8 expression • IFNG expression
|
gemcitabine • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
4years
Evaluation of Cyclophosphamide/GVAX Pancreas Followed by Listeria-mesothelin (CRS-207) With or Without Nivolumab in Patients with Pancreatic Cancer. (PubMed, Clin Cancer Res)
While the study did not meet its primary endpoint of improvement in OS of Arm A over Arm B, the OS was comparable to standard therapy. Objective responses and immunologic changes in the tumor microenvironment were evident.
Clinical • Journal
|
MSLN (Mesothelin) • CA 19-9 (Cancer antigen 19-9)
|
Opdivo (nivolumab) • CRS-207 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
4years
Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Undergoing Chemotherapy and Radiation Therapy for Stage I or Stage II Pancreatic Cancer That Can Be Removed by Surgery (clinicaltrials.gov)
P2, N=87, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active, not recruiting --> Completed
Clinical • Trial completion • Combination therapy
|
MSLN (Mesothelin) • CD4 (CD4 Molecule) • FOXP3 (Forkhead Box P3)
|
cyclophosphamide • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
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