drugset / Trial / NCT03190265
Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer
Phase 2
Completed
61 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Aduro Biotech, Inc. · collabBristol-Myers Squibb · collabNational Cancer Institute (NCI) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2017-12-14
- Primary completion
- 2022-08-03
- Completion
- 2023-08-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CRS-207 | Vaccine | 1e+09 unknown | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 200 mg/m2 | Intravenous |
| Subject | GVAX Pancreas Vaccine | Vaccine | — | — |
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 360 mg | Intravenous |