Phase 2 Trial of Maintenance Vigil for High Risk Stage IIIb-IV Ovarian Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 440
Summary
- Conditions
- Ovarian Cancer
- Ovarian Neoplasms
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
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 ...
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.
Tracking Information
- NCT #
- NCT02346747
- Collaborators
- Not Provided
- Investigators
- Study Director: Luisa Manning, MD Gradalis, Inc.