A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Vigil Engineered Autologous Tumor Cell Immunotherapy in Subjects With Stage IIIb-IV Ovarian Cancer in Clinical Complete Response Following Surgery and Primary Chemotherapy

Trial ID # NCT02346747
Phase II
Drug Class Immunotherapy: Vaccine/TGFbeta
Drug Name Gemogenovatucel-T
Alternate Drug Names Vigil, bi-shRNA-furin/GMCSF-expressing autologous tumor cell vaccine, bi-shRNA-furin and granulocyte macrophage colony stimulating factor augmented autologous tumor cell vaccine, FANG vaccine
Drugs in Trial Gemogenovatucel-T
Eligible Participant

Stage IIIb/IIIc/IV disease with CR after first-line therapy

Patients Enrolled

91

Therapy Setting

Maintenance

Study Design

Double Blind, Randomized

Endpoints

RFS, OS

Reference

Rocconi RP et al. Randomized double-blind placebo controlled trial of primary maintenance vigil immunotherapy (VITAL study) in stage III/IV ovarian cancer: Efficacy assessment in BRCA1/2-wt patients. SGO (2020) abstract LBA7
https://sgo.confex.com/sgo/2020/meetingapp.cgi/Paper/17080