🏛️ Verified NIH Record • Updated 2025-10-28
A Trial of Vigil for Participants With Ovarian Cancer (NCT02346747)
🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Gradalis, Inc.
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to compare participants with ovarian, fallopian tube or primary peritoneal cancer when treated with investigational product (Vigil) compared to placebo. The main question it aims to answer is "Will participants who receive treatment with Vigil have a longer time to disease recurrence versus the participants that were not given Vigil?"
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (19 items) and avoid the listed exclusions (11 items).
Location: University of South Alabama Mitchell Cancer Institute — Mobile, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: Subjects will be excluded from this study if they meet any of the following criteria (at the time of tissue procurement or at randomization):
- Surgery involving general anesthesia, radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to randomization.
- Histologically confirmed papillary serous adenocarcinoma of the uterus or disease involving myometrium/endometrium.
- Systemic immunosuppressive therapy within 14 days of randomization.
- Subjects requiring chronic steroid or immunosuppressive regimens are excluded except inhaled / intranasal steroids and short term systemic steroids \<30 days duration and ≤0.25 mg/kg prednisone-equivalent per day are allowed.
- Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months).
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects with history of brain metastases.
- Subjects with known HIV or chronic Hepatitis B or C infection.
- Prior solid organ or bone marrow transplant.
- History of or active autoimmune disease (e.g., autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus erythematosus, Sjogren's syndrome, scleroderma, myasthenia gravis, Goodpasture's syndrome, Addison's disease, Hashimoto's thyroiditis, or Graves disease). Persons with vitiligo are not excluded. Diabetics are not excluded if the condition is well controlled.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (26 Sites)
- University of South Alabama Mitchell Cancer Institute — Mobile, Alabama
- Southern California Permanente Medical Group — Irvine, California
- Palo Alto Foundation Medical Group — San Francisco, California
- University Of Miami Sylvester Comprehensive Cancer Center — Miami, Florida
- Moffitt Cancer Center — Tampa, Florida
- Florida Cancer Specialists — West Palm Beach, Florida
- Georgia Cancer Center at Augusta University — Augusta, Georgia
- University Of Kentucky Markey Cancer Center — Lexington, Kentucky
- Maine Medical Center: MMP Women's Health — Scarborough, Maine
- Dana Farber Cancer Institute: Gynecologic Oncology — Boston, Massachusetts
- Henry Ford Health System — Detroit, Michigan
- Billings Clinic — Billings, Montana
- Nebraska Methodist Hospital — Omaha, Nebraska
- Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center — Lebanon, New Hampshire
- University of New Mexico Cancer Center — Albuquerque, New Mexico
- Duke University Medical Center, Department of Medicine - Oncology — Durham, North Carolina
- Barrett Cancer Center University of Cincinnati Medical Center — Cincinnati, Ohio
- Stephenson Cancer Center at University of Oklahoma — Oklahoma City, Oklahoma
- AMD Asplundh Cancer Pavilion — Abington, Pennsylvania
- St. Luke's Health Network — Bethlehem, Pennsylvania
- Fox Chase Cancer Center — Philadelphia, Pennsylvania
- Prisma Health Cancer Institute — Greenville, South Carolina
- Mary Crowley Cancer Research Centers — Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas
- Cancer Care Northwest — Spokane, Washington
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.