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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:
9d
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 completion date: May 2026 --> Sep 2026 | Trial primary completion date: May 2026 --> Sep 2026
Trial completion date • Trial primary completion date • IO biomarker
|
Opdivo (nivolumab) • cyclophosphamide • BMS-986253 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • urelumab (BMS-663513)
1m
Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas. (clinicaltrials.gov)
P1/2, N=22, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | N=46 --> 22
Enrollment change
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Opdivo (nivolumab) • BMS-813160 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
3ms
Safety and immunologic impact of neoadjuvant/adjuvant GVAX, cyclophosphamide, pembrolizumab, and anti-CSF1R agent IMC-CS4 in pancreatic adenocarcinoma. (PubMed, Front Immunol)
CI has a manageable safety profile and leads to increased intratumoral cytotoxic effector T cells. https://clinicaltrials.gov/study/NCT03153410, identifier NCT03153410.
Clinical • Journal
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PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CSF1R (Colony stimulating factor 1 receptor) • CSF2 (Colony stimulating factor 2)
|
Keytruda (pembrolizumab) • cyclophosphamide • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • LY3022855
3ms
The combination of a cancer vaccine, pembrolizumab, and stereotactic body radiation in patients with locally advanced pancreatic cancer: a single-arm, phase II study. (PubMed, Nat Commun)
However, patients with unresectable disease still maintained significantly worse DMFS and OS. The regimen demonstrated a manageable safety profile.
P2 data • Journal
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CSF2 (Colony stimulating factor 2)
|
Keytruda (pembrolizumab) • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
5ms
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
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KRAS (KRAS proto-oncogene GTPase) • MSLN (Mesothelin)
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KRAS mutation
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Opdivo (nivolumab) • Yervoy (ipilimumab) • CRS-207 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
7ms
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
|
Opdivo (nivolumab) • cyclophosphamide • BMS-986253 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • urelumab (BMS-663513)
9ms
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
|
Opdivo (nivolumab) • BMS-813160 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
10ms
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)
11ms
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)
12ms
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
|
KRAS (KRAS proto-oncogene GTPase)
|
cyclophosphamide • balstilimab (AGEN2034) • AGEN2373 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • Hiltonol (poly-ICLC) • KRAS peptide vaccine
1year
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)
|
Opdivo (nivolumab) • gemcitabine • albumin-bound paclitaxel • cyclophosphamide • irinotecan • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
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: 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)
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