Phase 2 Trial of Maintenance Vigil for High Risk Stage IIIb-IV Ovarian Cancer (VITAL)
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|ClinicalTrials.gov Identifier: NCT02346747|
Recruitment Status : Active, not recruiting
First Posted : January 27, 2015
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Ovarian Neoplasms||Biological: Vigil Biological: Placebo||Phase 2|
This is a multicenter, randomized, double-blind, placebo-controlled, Phase 2 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 86 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 objective is determining RFS of subjects randomized to Vigil versus placebo.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||February 2015|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||December 2021|
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.
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.
- Recurrence Free Survival [ Time Frame: 7-14 months after surgery and chemotherapy ]The primary endpoint of Recurrence Free Survival is the time from the randomization date to either the date the subject is first recorded as having disease recurrence (even if the subject went off treatment because of toxicity), or the date of death if the subject dies due to any causes before recurrence.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346747
|Study Director:||Luisa Manning, MD||Gradalis, Inc.|