18 trials tracked · 3 active · last refreshed 2026-08-10
GVAX pancreatic is an older allogeneic (donor-derived, not the patient's own cells) whole-tumor-cell vaccine engineered to secrete GM-CSF, an immune-stimulating protein — one of the longest-running cancer vaccine approaches, tested here almost always as part of a combination regimen rather than alone. Of its 18 tracked trials, most are completed studies pairing it with cyclophosphamide ("CY/GVAX"), a checkpoint inhibitor (nivolumab, pembrolizumab), and sometimes a second agent like CRS-207 (a listeria-based vaccine) or an IDO inhibitor — reflecting a long history of combination testing rather than a single pivotal trial.
Only 3 trials are still active, the most recent comparing a neoadjuvant/adjuvant GVAX regimen against a newer mutant-KRAS-targeted vaccine (mKRASvax) alongside checkpoint inhibitors — a sign the field is now testing GVAX's older whole-cell approach against newer, more targeted vaccine designs like ELI-002 above, rather than advancing GVAX on its own.
Click a row for what it's testing, where, and how many participants.
| NCT ID | Title | Phase | Status | Started | |
|---|---|---|---|---|---|
| ▸ | NCT06782932 | Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer | Phase I, Phase II | Recruiting | 2025-05-27 |
The purpose of this study is to determine the optimal dose of AGEN2373 that is safe when given in combination with balstilimab and Pancreatic GVAX Whole Cell Vaccine and evaluate the safety and clinical activity of balstilimab and AGEN2373 in combination with GVAX (Arm 1) or mKRASvax (Arm 2) in surgically resectable pancreatic adenocarcinoma. Enrollment 38 (estimated) Sites 1 across 1 country Countries United States Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Primary outcome: Dose Limiting Toxicities in Phase I participants | |||||
| ▸ | NCT03767582 | Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas. | Phase I, Phase II | Completed | 2019-12-12 |
The purpose of this study is to evaluate if the combination of nivolumab and a CCR2/CCR5 dual antagonist (BMS-813160) with GVAX is safe in patients with locally advanced pancreatic cancer (LAPC) who have received chemotherapy and radiotherapy, and to see if this combination therapy enhances the infiltration of CD8+CD137+ cells in PDACs . Enrollment 22 (actual) Sites 1 across 1 country Countries United States Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Primary outcome: Study Drug-related Adverse Events | |||||
| ▸ | NCT03153410 | Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas | Early Phase I | Completed | 2018-09-27 |
The purpose of this study is to evaluate whether combining cyclophosphamide (CY), pembrolizumab, GVAX and IMC-CS4 is effective and safe in patients with borderline resectable pancreatic cancer. Enrollment 11 (actual) Sites 1 across 1 country Countries United States Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Primary outcome: Number of Patients With a Treatment-related Immunologic Effect | |||||
| ▸ | NCT03161379 | GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer | Phase II | Completed | 2018-02-02 |
The purpose of this study is to evaluate the safety and clinical activity of FOLFIRINOX along with a whole cell vaccine with immune modulating doses of cyclophosphamide and nivolumab combined with Stereotactic Body Radiation Therapy (SBRT) in patients with pancreatic cancer. Enrollment 31 (actual) Sites 2 across 1 country Countries United States Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Primary outcome: CD8+ T Cell Density in Tumor Tissue | |||||
| ▸ | NCT03006302 | Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer | Phase II | Completed | 2018-01-31 |
This study will enroll patients who have metastatic pancreatic cancer and have progressed on prior chemotherapy. Part 1 (dose escalation) participants will receive epacadostat/pembrolizumab/cyclophosphamide(CY)/GVAX pancreas vaccine followed by epacadostat/pembrolizumab/CRS-207, Part 1X (dose escalation) participants will receive epacadostat/pembrolizumab/CRS-207. Part 2X (dose expansion) participants will receive epacadostat/pembrolizumab/CRS-207. The primary objectives of this study are to determine the recommended dose of epacadostat in this combination and assess survival of subjects in both treatment groups. Enrollment 41 (actual) Sites 1 across 1 country Countries United States Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Primary outcome: Maximum Tolerated Dose (MTD) of Epacadostat | |||||
| ▸ | NCT03190265 | Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer | Phase II | Completed | 2017-12-14 |
The purpose of this study is to study the safety and clinical activity of nivolumab and ipilimumab in combination with either sequential administration of CY/GVAX pancreas vaccine followed by CRS-207 (Arm A) or with administration of CRS-207 alone (Arm B) in patients with pancreatic cancer. Enrollment 61 (actual) Sites 1 across 1 country Countries United States Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Primary outcome: Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1) | |||||
| ▸ | NCT02648282 | Study With CY, Pembrolizumab, GVAX Pancreas Vaccine, and SBRT in Patients With Locally Advanced Pancreatic Cancer | Phase II | Completed | 2016-07-18 |
This study will be looking at whether combining cyclophosphamide, pembrolizumab (an antibody that blocks negative signals to T cells), GVAX (pancreatic cancer vaccine), and SBRT (focused radiation) is effective (anti-tumor activity) and safe in patients with locally advanced pancreatic cancer. Enrollment 58 (actual) Sites 1 across 1 country Countries United States Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Primary outcome: Distant Metastasis Free Survival (DMFS) | |||||
| ▸ | NCT02451982 | Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas | Phase II | Active, not recruiting | 2016-03-28 |
This platform trial will evaluate various immunotherapy combinations given in the neo-adjuvant and adjuvant setting in patients with surgically resectable pancreatic ductal adenocarcinoma. Enrollment 76 (estimated) Sites 1 across 1 country Countries United States Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Primary outcome: IL17A expression | |||||
| ▸ | NCT02243371 | GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab | Phase II | Completed | 2015-01-02 |
The primary objective of this study is to compare the overall survival (OS) of subjects with previously treated metastatic pancreatic cancer treated with cyclophosphamide (CY)/nivolumab/GVAX pancreas vaccine followed by nivolumab/CRS-207 (Arm A) to subjects treated with CY/GVAX pancreas vaccine followed by CRS-207 (Arm B). Enrollment 93 (actual) Sites 5 across 1 country Countries United States Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Primary outcome: Overall Survival (OS) | |||||
| ▸ | NCT02004262 | Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting | Phase II | Completed | 2014-02-05 |
Test the safety, immune response and efficacy of GVAX pancreas vaccine (with cyclophosphamide) and CRS-207 compared to chemotherapy or CRS-207 alone in adults with previously treated metastatic pancreatic adenocarcinoma Enrollment 303 (actual) Sites 21 across 2 countries Countries Canada, United States Sponsor Aduro Biotech, Inc. Primary outcome: Primary Cohort: Overall Survival (OS) Censored at 138 Deaths (ITT Set) | |||||
| ▸ | NCT01896869 | FOLFIRINOX Followed by Ipilimumab With Pancreatic Tumor Vaccine in Treatment of Metastatic Pancreatic Cancer | Phase II | Completed | 2013-11 |
This study will enroll patients who have metastatic pancreatic cancer with stable disease on FOLFIRINOX chemotherapy. The main purpose of this study is to compare survival between patients that receive ipilimumab and a pancreatic tumor vaccine and patients who continue to receive FOLFIRINOX. Funding Source - FDA Office of Orphan Product Development (OOPD) Enrollment 83 (actual) Sites 3 across 1 country Countries United States Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Primary outcome: Overall Survival (OS) | |||||
| ▸ | NCT01595321 | Pancreatic Tumor Cell Vaccine (GVAX), Cyclophosphamide, SBRT, and FOLFIRINOX in Patients With Resected Adenocarcinoma of the Pancreas | Phase II | Completed | 2012-10-29 |
The purpose of this study is to estimate safety of GVAX Pancreas Vaccine (GVAX) with immune modulating doses of cyclophosphamide (Cy) followed by SBRT and FOLFIRINOX chemotherapy in pancreatic cancer patients after surgery. Enrollment 19 (actual) Sites 1 across 1 country Countries United States Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Primary outcome: Dose Limiting Toxicities | |||||
| ▸ | NCT01417000 | Safety and Efficacy of Combination Listeria/GVAX Immunotherapy in Pancreatic Cancer | Phase II | Completed | 2011-09-21 |
Test the safety, immune response and efficacy of GVAX pancreas vaccine (with cyclophosphamide) and CRS-207 compared to GVAX pancreas vaccine (with cyclophosphamide) alone in adults who have failed or refused prior treatment for metastatic pancreatic cancer. Enrollment 93 (actual) Sites 10 across 1 country Countries United States Sponsor Aduro Biotech, Inc. Primary outcome: Overall Survival (OS) in Subjects Receiving Test Treatments (FAS) | |||||
| ▸ | NCT01088789 | Boost GVAX Pancreas Vaccine With or Without CY in Patients With Pancreas Cancer | Phase II | Active, not recruiting | 2010-04-20 |
The purpose of this study is to evaluate the safety and feasibility of long term boost vaccination of a lethally irradiated, allogenic pancreatic tumor cell vaccine transfected with the granulocyte macrophage colony-stimulating factor (GM-CSF) gene (GVAX Pancreas Vaccine) alone or given in combination with either a single intravenous dose or daily metronomic oral doses of cyclophosphamide for the treatment of patients with surgically resected adenocarcinoma of the pancreas. Enrollment 71 (actual) Sites 1 across 1 country Countries United States Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Primary outcome: Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation | |||||
| ▸ | NCT00727441 | 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 | Phase II | Completed | 2008-07-02 |
RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an effective immune response to kill pancreatic cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vaccine therapy together with cyclophosphamide may kill more tumor cells. It is not yet known whether vaccine therapy is more effective with or without cyclophosphamide in treating patients with pancreatic cancer. PURPOSE: This randomized clinical trial is studying the side effects of vaccine therapy and to see how well it works when given 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. Enrollment 87 (actual) Sites 1 across 1 country Countries United States Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Primary outcome: Safety as Measured by Number of Participants With Treatment-related Grade 3 or 4 Local and Systemic Toxicity as Defined by NCI CTCAE v3.0 | |||||
| ▸ | NCT00389610 | Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer | Phase II | Completed | 2006-09-11 |
This is an open label, phase II trial study of adjuvant GVAX pancreas vaccine in patients with pancreatic cancer. Enrollment 56 (actual) Sites 1 across 1 country Countries United States Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Primary outcome: Number of Patients Experiencing a Grade 3 or Above Treatment- Related Toxicity | |||||
| ▸ | NCT00305760 | Vaccine Therapy, Cyclophosphamide, and Cetuximab in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer | Phase II | Completed | 2005-12 |
RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vaccine therapy together with cyclophosphamide and cetuximab may kill more tumor cells. PURPOSE: This phase II trial is studying how well vaccine therapy works when given together with cyclophosphamide and cetuximab in treating patients with metastatic or locally advanced pancreatic cancer. Enrollment 60 (actual) Sites 1 across 1 country Countries United States Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Primary outcome: Safety of Combining the Pancreatic Tumor Vaccine in Sequence With Cyclophosphamide and Erbitux. Safety is Defined as the Number of Treatment-related Grade 3 or 4 Adverse Events Observed in Greater Than 5% of the Patient Population | |||||
| ▸ | NCT00084383 | Vaccine Therapy Combined With Adjuvant Chemoradiotherapy in Treating Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas | Phase II | Completed | 2002-01 |
RATIONALE: Vaccines made from gene-modified pancreatic cancer cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving vaccine therapy together with chemotherapy and radiation therapy after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well giving vaccine therapy together with adjuvant chemoradiotherapy works in treating patients with resected stage I or stage II adenocarcinoma (cancer) of the pancreas. Enrollment 60 (actual) Sites 1 across 1 country Countries United States Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Primary outcome: Overall Survival | |||||
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