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GVAX Pancreatic Cancer Vaccine · 1 trial · 1 indication
DMFS is defined as the duration of time from start of treatment to identification of distant metastases on imaging or death, whichever occurs first. Estimation based on the Kaplan-Meier curve.
| Arm | Type | Description |
|---|---|---|
| Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Cyclophosphamide | DRUG | 200 mg/m2 is to be administered as a 30 minute IV infusion one day prior to GVAX Pancreas Vaccine every 21 days for a total of 8 doses. In the extended treatment phase, eligible patients may receive 200 mg/m2 as a 30 minute IV infusion one day prior to GVAX Pancreas Vaccine every 6 months for an additional 4 doses. |
| GVAX Pancreatic Cancer Vaccine | DRUG | 2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells is to be administered one day after CY and pembrolizumab for a total of 8 doses. In the extended treatment phase, eligible patients may receive 2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells administered one day after CY every 6 months for an additional 4 doses. |
| Pembrolizumab | DRUG | 200 mg will be administered as a 30 minute IV infusion one day prior to the GVAX pancreas vaccine every 21 days for a total of 8 doses. In the extended treatment phase, eligible patients may receive 200 mg as a 30 minute IV infusion every 21 days for an additional 9 doses. |
| SBRT | RADIATION | Patients will receive SBRT (6.6 Gy for 5 days) with the second dose of combined immunotherapy (CY/Pembrolizumab/GVAX Pancreas Vaccine). |
Inclusion Criteria: 1. Locally advanced pancreatic adenocarcinoma 2. Patients must have received mFOLFIRINOX or Gemcitabine/ Abraxane based chemotherapy for 4 cycles with last dose of therapy between 2-5 weeks of study enrollment. 3. Age \>18 years 4. No metastatic disease 5. ECOG Performance Statu...
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GVAX Pancreatic Cancer Vaccine is an investigational cancer vaccine being studied for the treatment of pancreatic cancer. It is currently in Phase 2 clinical development and has been evaluated in patients with locally advanced pancreatic cancer.
GVAX Pancreatic Cancer Vaccine is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The vaccine is an investigational therapy and has not been approved by regulatory authorities.
GVAX Pancreatic Cancer Vaccine is in Phase 2 clinical development. It is an investigational agent, meaning it has not yet received regulatory approval and is still being studied for safety and efficacy in patients with pancreatic cancer.
GVAX Pancreatic Cancer Vaccine has been studied in one completed Phase 2 clinical trial, identified as NCT02648282. This trial, titled 'Study With CY, Pembrolizumab, GVAX Pancreas Vaccine, and SBRT in Patients With Locally Advanced Pancreatic Cancer,' enrolled 58 participants in the United States.
GVAX Pancreatic Cancer Vaccine is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The completed trial NCT02648282 was an uncontrolled study, and the vaccine has not yet demonstrated sufficient evidence for regulatory approval.