- |||||||||| GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) / Novartis, Opdivo (nivolumab) / Ono Pharma, BMS
Trial completion, Trial completion date, Trial primary completion date, Combination therapy: GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer (clinicaltrials.gov) - Feb 29, 2024 P2, N=28, Completed, Altogether our findings shed light on the plasticity of TLS in neoadjuvant immunotherapy and suggest future immunotherapy approaches should target both humoral and cytotoxic NK/T cell compartments to augment responses in solid tumors. Active, not recruiting --> Completed | Trial completion date: Sep 2024 --> Feb 2024 | Trial primary completion date: Sep 2024 --> Feb 2024
- |||||||||| BMS-813160 / BMS, GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) / Novartis, Opdivo (nivolumab) / Ono Pharma, BMS
Trial completion date, Trial primary completion date, Metastases: Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas. (clinicaltrials.gov) - Feb 15, 2024 P1/2, N=30, Recruiting, Active, not recruiting --> Completed | Trial completion date: Sep 2024 --> Feb 2024 | Trial primary completion date: Sep 2024 --> Feb 2024 Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| LY3022855 / Eli Lilly, GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) / Novartis, Keytruda (pembrolizumab) / Merck (MSD)
Trial completion, Combination therapy: Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov) - Jan 28, 2024 P1, N=12, Completed, These findings have guided the design of next radioimmunotherapy studies by targeting M2-like TAM in PDACs. Active, not recruiting --> Completed
- |||||||||| Trial completion date, Metastases: Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer (clinicaltrials.gov) - Jan 3, 2024
P2, N=40, Active, not recruiting, Active, not recruiting --> Completed Trial completion date: Dec 2023 --> Dec 2024
- |||||||||| Enrollment closed, Trial completion date, Metastases: Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer (clinicaltrials.gov) - Mar 9, 2023
P2, N=61, Active, not recruiting, Trial completion date: Jan 2023 --> Jun 2023 | Trial primary completion date: Jan 2023 --> Jun 2023 Completed --> Active, not recruiting | Trial completion date: Oct 2022 --> Aug 2023
- |||||||||| GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) / Chinook Therap
Enrollment closed, Trial completion date, Trial primary completion date, Tumor cell: A Trial of Boost Vaccinations of Pancreatic Tumor Cell Vaccine (clinicaltrials.gov) - Mar 8, 2023 P2, N=71, Active, not recruiting, Completed --> Active, not recruiting | Trial completion date: Oct 2022 --> Aug 2023 Recruiting --> Active, not recruiting | Trial completion date: Apr 2023 --> Aug 2023 | Trial primary completion date: Apr 2023 --> Aug 2023
- |||||||||| GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) / Novartis, Keytruda (pembrolizumab) / Merck (MSD)
Trial completion, Trial completion date, Combination therapy, Metastases: Study With CY, Pembrolizumab, GVAX Pancreas Vaccine, and SBRT in Patients With Locally Advanced Pancreatic Cancer (clinicaltrials.gov) - Feb 28, 2023 P2, N=58, Completed, Recruiting --> Active, not recruiting | Trial completion date: Apr 2023 --> Aug 2023 | Trial primary completion date: Apr 2023 --> Aug 2023 Active, not recruiting --> Completed | Trial completion date: Jan 2023 --> Jun 2022
- |||||||||| BMS-813160 / BMS, GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) / Novartis, Opdivo (nivolumab) / Ono Pharma, BMS
Trial completion date, Trial primary completion date, Metastases: Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas. (clinicaltrials.gov) - Feb 3, 2023 P1/2, N=30, Recruiting, Active, not recruiting --> Completed | Trial completion date: Jan 2023 --> Jun 2022 Trial completion date: Mar 2023 --> Dec 2023 | Trial primary completion date: Mar 2023 --> Dec 2023
- |||||||||| GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) / Novartis
Trial completion, Tumor cell: Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer (clinicaltrials.gov) - Jan 25, 2023 P2, N=56, Completed, Trial completion date: Mar 2023 --> Dec 2023 | Trial primary completion date: Mar 2023 --> Dec 2023 Active, not recruiting --> Completed
- |||||||||| LY3022855 / Eli Lilly, GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) / Novartis, Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date, Combination therapy: Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov) - Jan 9, 2023 P1, N=12, Active, not recruiting, Active, not recruiting --> Completed Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
- |||||||||| Trial completion date, Trial primary completion date, Metastases: Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer (clinicaltrials.gov) - Jan 5, 2023
P2, N=40, Active, not recruiting, Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023 Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
- |||||||||| GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) / Chinook Therap
Biomarker, Journal, Tumor microenvironment, PD(L)-1 Biomarker, IO biomarker: Multi-omic analyses of changes in the tumor microenvironment of pancreatic adenocarcinoma following neoadjuvant treatment with anti-PD-1 therapy. (Pubmed Central) - Nov 19, 2022 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.
- |||||||||| GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) / Novartis
Trial primary completion date, Tumor cell: Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer (clinicaltrials.gov) - Jun 22, 2022 P2, N=56, Active, not recruiting, 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. Trial primary completion date: Dec 2022 --> Oct 2021
- |||||||||| GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) / Novartis, Keytruda (pembrolizumab) / Merck (MSD)
Trial primary completion date, Combination therapy, Metastases: Study With CY, Pembrolizumab, GVAX Pancreas Vaccine, and SBRT in Patients With Locally Advanced Pancreatic Cancer (clinicaltrials.gov) - Jun 6, 2022 P2, N=58, Active, not recruiting, Trial primary completion date: Dec 2022 --> Oct 2021 Trial primary completion date: Jan 2023 --> Apr 2022
- |||||||||| Enrollment closed, Metastases: Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer (clinicaltrials.gov) - May 9, 2022
P2, N=40, Active, not recruiting, Trial primary completion date: Jan 2023 --> Apr 2022 Recruiting --> Active, not recruiting
- |||||||||| Trial completion date, Trial primary completion date, Metastases: Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer (clinicaltrials.gov) - Mar 25, 2022
P2, N=44, Recruiting, Recruiting --> Active, not recruiting Trial completion date: Mar 2023 --> Dec 2022 | Trial primary completion date: Mar 2023 --> Dec 2022
- |||||||||| GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) / Novartis, Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date, Combination therapy, Metastases: Study With CY, Pembrolizumab, GVAX Pancreas Vaccine, and SBRT in Patients With Locally Advanced Pancreatic Cancer (clinicaltrials.gov) - Mar 4, 2022 P2, N=58, Active, not recruiting, Trial completion date: Oct 2023 --> Jul 2023 | Trial primary completion date: Oct 2023 --> Jul 2023 Trial completion date: Jan 2022 --> Jan 2023 | Trial primary completion date: Jan 2022 --> Jan 2023
- |||||||||| Trial completion date, Trial primary completion date, Metastases: Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer (clinicaltrials.gov) - Mar 3, 2022
P2, N=44, Recruiting, Recruiting --> Active, not recruiting Trial completion date: Feb 2022 --> Mar 2023 | Trial primary completion date: Feb 2022 --> Mar 2023
- |||||||||| GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) / Novartis
Trial completion date, Trial primary completion date, Tumor cell: Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer (clinicaltrials.gov) - Jan 31, 2022 P2, N=56, Active, not recruiting, In-depth analysis of TLAs is warranted in future neoadjuvant immunotherapy clinical trials. Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
- |||||||||| LY3022855 / Eli Lilly, GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) / Novartis, Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date, Combination therapy: Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov) - Jan 31, 2022 P1, N=12, Active, not recruiting, Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022 Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
- |||||||||| GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) / Chinook Therap, Opdivo (nivolumab) / Ono Pharma, BMS
Neoadjuvant and adjuvant antitumor vaccination alone or combination with PD1 blockade and CD137 agonism in patients with resectable pancreatic adenocarcinoma. (In-Person Only | Level 1, West Hall; Online Only) - Jan 8, 2022 - Abstract #ASCOGI2022ASCO_GI_817; P2 Treatment was given as follows: Day 1 - Cyclophosphamide 200mg/m2 IV (All Arms), Nivolumab 480mg IV (Arms B, C), Urelumab 8mg IV (Arm C); Day 2 – GVAX ID (All Arms)...SOC regimes included (m)FOLFIRINOX, Gem +/- Cap/NAB-Paclitaxel... Despite a small sample size, combining GVAX with dual immune-targeting of PD-1 blockade and CD137 agonism was safe and may enhance DFS in rPDA pts treated in the perioperative and post-adjuvant settings.
- |||||||||| GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) / Novartis
Trial completion date, Trial primary completion date, Tumor cell: 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) - Jan 5, 2022 P=N/A, N=19, Active, not recruiting, Despite a small sample size, combining GVAX with dual immune-targeting of PD-1 blockade and CD137 agonism was safe and may enhance DFS in rPDA pts treated in the perioperative and post-adjuvant settings. Trial completion date: Dec 2021 --> Sep 2024 | Trial primary completion date: Dec 2021 --> Sep 2024
- |||||||||| GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) / Chinook Therap
Journal: Trials and tribulations of pancreatic cancer immunotherapy. (Pubmed Central) - Sep 16, 2021 Further, many have shown high rates of serious adverse effects and dose-limiting toxicities, and to date, immunotherapy regimens have not been successfully implemented in PDAC. Here, we provide a comprehensive summary of the key clinical trials exploring immunotherapy in PDAC, followed by a brief discussion of emerging molecular mechanisms that may explain the relative failure of immunotherapy in pancreas cancer thus far.
- |||||||||| GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) / Novartis, Opdivo (nivolumab) / Ono Pharma, BMS
Enrollment closed, Combination therapy: GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer (clinicaltrials.gov) - Sep 5, 2021 P2, N=30, Active, not recruiting, Here, we provide a comprehensive summary of the key clinical trials exploring immunotherapy in PDAC, followed by a brief discussion of emerging molecular mechanisms that may explain the relative failure of immunotherapy in pancreas cancer thus far. Recruiting --> Active, not recruiting
- |||||||||| GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) / Novartis
Trial completion date, Trial primary completion date, Tumor cell: 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) - Aug 20, 2021 P=N/A, N=19, Active, not recruiting, Recruiting --> Active, not recruiting Trial completion date: Aug 2021 --> Dec 2021 | Trial primary completion date: Aug 2021 --> Dec 2021
- |||||||||| LY3022855 / Eli Lilly, GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) / Novartis, Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date, Combination therapy: Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov) - Aug 19, 2021 P1, N=12, Active, not recruiting, Trial completion date: Aug 2021 --> Dec 2021 | Trial primary completion date: Aug 2021 --> Dec 2021 Trial completion date: Sep 2021 --> Dec 2021 | Trial primary completion date: Sep 2021 --> Dec 2021
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