Trials / Terminated
TerminatedNCT03376659
Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma
A Phase I/II Trial of the PD-L1 Inhibitor, Durvalumab Plus CV301 in Combination With Maintenance Chemotherapy for Patients With Metastatic Colorectal or Pancreatic Adenocarcinoma
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Georgetown University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Metastatic Colorectal Cancer
- Colorectal Adenocarcinoma
- Pancreatic Adenocarcinoma
- Metastatic Pancreatic Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Durvalumab | 750mg IV q2 weeks |
| BIOLOGICAL | CV301 | MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.) FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5 mL given s.c. |
| DRUG | Capecitabine | 1000mg orally twice a day, Monday - Friday Weekly |
| DRUG | Bevacizumab | 5mg/kg IV q2weeks |
Timeline
- Start date
- 2018-08-08
- Primary completion
- 2021-08-30
- Completion
- 2023-08-01
- First posted
- 2017-12-18
- Last updated
- 2024-02-05
- Results posted
- 2023-01-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03376659. Inclusion in this directory is not an endorsement.