Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02243371 | GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab | PHASE2 | COMPLETED | 93 | — | — | Jan 2, 2015 | Jul 21, 2017 | Apr 6, 2021 | 5 | United States |
OS will be measured from date of randomization until death or end of followup (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis).
| Arm | Type | Description |
|---|---|---|
| Arm A: CY/ GVAX/ CRS-207/ nivolumab | EXPERIMENTAL | - |
| Arm B: CY/ GVAX/ CRS-207 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CRS-207 | BIOLOGICAL | 1 × 10\^9 CFU administered IV on Day 2 of Cycles 3-6 |
| nivolumab | DRUG | 3 mg/kg administered IV on Day 1 of Cycles 1-6 |
| GVAX | BIOLOGICAL | 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2 |
| CY | DRUG | 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2 |
Inclusion Criteria: * Age ≥18 years. * Have histologically- or cytologically-proven adenocarcinoma of the pancreas. Patients with mixed histology will be excluded. * Have metastatic disease. * Have failed only 1 prior chemotherapy regimen for metastatic pancreatic cancer. * Patients with the presen...