drugset / Trial / NCT03376659
Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma
Phase 1/2
Terminated
8 enrolled
Georgetown University
Bavarian Nordic · collabEmory University · collabGeorge Mason University · collabIndiana University · collabMayo Clinic · collabMedImmune LLC · collabNational Cancer Institute (NCI) · collabThomas Jefferson University · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a dual arm, open label phase I/II study to evaluate the safety and clinical activity of the combination of durvalumab with CV301 in combination with maintenance chemotherapy for patients with metastatic colorectal or pancreatic cancer whose disease is stable on, or responding to 1st line therapy for metastatic disease. Patients with metastatic colorectal or pancreatic adenocarcinoma who still have an adequate performance status and normal hepatic and renal function will be eligible.
Timeline
- Start
- 2018-08-08
- Primary completion
- 2021-08-30
- Completion
- 2023-08-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Capecitabine | Small molecule | 1000 mg | Oral |
| Subject | Durvalumab | Monoclonal antibody | 750 mg | Intravenous |
| Subject | FPV-CV301 | Vaccine | 1e+09 unknown | Subcutaneous |
| Subject | MVA-BN-CV301 | Vaccine | 1.6e+09 unknown | Subcutaneous |