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

Efficacy

91 patients
VIGIL (n=46) vs Placebo (n=45):
RFS (from time of randomization): 12.7 vs 8.4 months, HR: 0.67, p=0.065

BRCA WT patients:
VIGIL (n=39) vs Placebo (n=28):
RFS (from time of randomization): 12.7 vs 8.0 months, HR: 0.49, p=0.014
RFS (from time of surgery/procurement): NR vs 14.8 months
OS: NR vs 41.4 months, HR: 0.42, p=0.02
Relapsed patients at median follow up of 38.6 months: 51 vs 79%

Clinically Significant Adverse Events

Serious AE: none
Grade 3-4 AE: none

Conclusion

Vigil immunotherapy as maintenance after first-line therapy in stage III–IV ovarian cancer is well tolerated and shows clinical benefit, particularly for BRCA WT patients

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

Rocconi RP et al. Randomized Double-Blind Placebo Controlled Trial of Frontline Maintenance Vigil Immunotherapy (VITAL study) in Stage III/IV Ovarian Cancer: Efficacy Assessment in BRCA1/2-wt Patients. IGCS (2020) Plenary V, abstract 15
https://www.clearityfoundation.org/wp-content/uploads/2020/09/VIGIL-IGCS-2020-abstract.pdf