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Vigil Vaccine + Bevacizumab in Recurrent Ovarian Cancer
NCT01551745Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2012
- Primary completion
- Apr 2016
- Countries
- 1
- Sponsor
- Gradalis, Inc.
- Modality
- Vaccines & Immunotherapeutics, Small Interfering RNA (siRNA), Cell Therapies
- Drugs
- gemogenovatucel-T
- Conditions
- ovarian cancer
01
Overview
Phase 2, open-label, single-arm trial of gemogenovatucel-T in ovarian cancer, sponsored by Gradalis, Inc. Primary endpoints: Time to Progression at 24 months and Response Rate up to 12 months. Started Mar 2012; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Vigil Vaccine + Bevacizumab
Vigil vaccine intradermal injection every 4 weeks and Bevacizumab intravenously every 2 weeks.
03
Who it enrols
Patients with recurrent/refractory papillary serous or endometrioid ovarian cancer who previously participated in study CL-PTL 105, have available Vigil vaccine, and meet organ function criteria.
04
Endpoints
Primary
Time to Progression
Response Rate
Secondary
Number of Alive Subjects
Enzyme-Linked ImmunoSorbent Spot
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