Phase 3 Trial of Maintenance Vigil for High Risk Stage IIIb-IV Ovarian Cancer (VITAL)
|Ovarian Cancer Ovarian Neoplasms||Biological: Vigil Biological: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Phase 3 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|
- Recurrence Free Survival [ Time Frame: 7-14 months after surgery and chemotherapy ]
- Overall Survival [ Time Frame: 54 months ]The assumed median survival in the control arm is 54 months.
|Study Start Date:||February 2015|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Group A
Group A will receive 1.0 x 10e7 cells of gene transfected, irradiated, autologous tumor cells via intradermal injection once a month for ≥4 to a maximum of 12 doses.
bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy
Placebo Comparator: Group B
Group B will receive "freeze" media (10% DMSO, 1% human serum albumin in Plasma-Lyte) via intradermal injection once a month for ≥4 to a maximum of 12 doses.
This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study of maintenance Vigil Ovarian (gemogenovatucel-T) engineered autologous tumor cells (EATC) in women with Stage IIIb, IIIc or IV high-grade papillary serous/ clear cell / endometrioid ovarian, fallopian tube or primary peritoneal cancer. Subjects will have had a minimum of 4 and a maximum of 12 doses of Vigil prepared and stored from ovarian tumor cells obtained at the time of primary surgical debulking or initial diagnostic / evaluative laparoscopy (tissue for immunotherapy manufacture must be procured prior to initiation of neoadjuvant chemotherapy). An equal number of placebo doses will be manufactured. Subjects will have achieved a clinically defined complete response following primary surgery and adjuvant chemotherapy.
Investigational treatment must start no less than 3 weeks and no more than 8 weeks following completion of chemotherapy.
Approximately 222 subjects will be randomized 1:1 to receive either monthly intradermal Vigil or placebo for at least 4 to a maximum of 12 administrations. Randomization will be stratified by (i) extent of surgical cytoreduction (complete/microscopic versus macroscopic residual disease) and (ii) neoadjuvant versus adjuvant chemotherapy. The primary objective is determining RFS of subjects randomized to Vigil versus placebo, and the key secondary objective is overall survival (OS) of subjects randomized to Vigil versus placebo.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02346747
Show 26 Study Locations
|Study Director:||Luisa Manning, MD||Gradalis, Inc.|