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Clinical Trials in the USA / NCT02346747
Active, not recruiting Phase 2

A Trial of Vigil for Participants With Ovarian Cancer

NCT02346747 · tracked via the Priya Life Science USA tracker
Sponsor
Gradalis, Inc.
Phase
Phase 2
Started
2015-02
Last updated
2025-10-29

Condition(s) studied

Ovarian CancerOvarian Neoplasms

Investigational drug(s) / intervention(s)

VigilPlacebo

Vigil: The bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine, Vigil is made up of irradiated autologous tumor cells which have been electroporated ex vivo with the Vigil plasmid designed to suppress expression of both the TGFβ1 and TGFβ2 proteins while simultaneously expressing rhGMCSF protein.

Placebo: To maintain placebo effect and eliminate bias due to volumetric differences, the number of Vigil doses manufactured from harvested tissue (except if below 4) will be used to guide manufacture of the same number of doses of placebo for each subject. Placebo will consist of "freeze" media \[10% DMSO (dimethyl sulfoxide; Cryoserv USP; Mylan Institutional USP), 1% Human Serum Albumin (ABO Pharmaceuticals) in Plasma-Lyte A, pH 7.4 (Baxter)\]. Depending upon randomization assignment, placebo or Vigil will be delivered in identical vials and drawn up in 'covered' syringes for intradermal injection.

Study summary

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?"

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria Subjects will be eligible for tissue procurement for the Vigil manufacturing process if they meet all of the following criteria: 1. Presumptive Stage IIIb, IIIc or IV high-grade papillary serous/clear cell/endometrioid ovarian, fallopian tube or primary peritoneal cancer. 2. No chemotherapy prior or investigational agents prior to tissue acquisition for Vigil manufacture. 3. No other malignancy (excluding surgically cured nonmelanoma carcinomas of the skin and carcinoma in situ cervix) unless in remission for ≥ 2 years. 4. Anticipated availability of a cumulative mass of \~30 grams tissue ("golf-ball" size or approximately 3cm disease on CT scan) at time of diagnostic laparoscopy or primary surgical debulking. Infiltrating lumen (bowel, fallopian tube, urethra) tissue should not be used as Vigil immunotherapy material to minimize risk of bacterial contamination. 5. ECOG performance status (PS) 0-2 prior to diagnostic laparoscopy or debulking laparotomy. 6. No prior history of hypersensitivity reactions (HSR) with taxanes or platinums. 7. No prior history of allergies or sensitivities to gentamicin. 8. Female, 18 years of age or older. 9. Ability to understand and the willingness to sign a written informed consent document for tissue harvest. Subjects will be registered in this study if they meet all of the following inclusion criteria: 1. Histologically confirmed Stage IIIb, IIIc or IV high-grade papillary serous/clear cell/endometrioid ovarian, fallopian tube or primary peritoneal. 2. Completion of primary surgical debulking including hysterectomy and bilateral salpingo oophorectomy, and at least 5 but no more than 8 cycles of platinum / taxane adjuvant chemotherapy or chemotherapy as per Category 1 recommendations of the NCCN guidelines, including 5-8 cycles adjuvant intraperitoneal + intravenous (IP/IV) chemotherapy, or 5-8 cycles of intravenous chemotherapy divided and administered as neoadjuvant and adjuvant therapy flanking primary debulking surgery. 3. Clinically defined complete response (cCR) following completion of primary surgical debulking and eligible chemotherapy. cCR defined as no evidence of malignancy on chest x-ray (CT scan is acceptable) and CT scan or MRI of the abdomen and pelvis, normal physical examination, CA-125 antigen level ≤ 35 U/ml (assessed ≥ 2 weeks following removal of catheter in subjects receiving intraperitoneal/intravenous chemotherapy) and no findings on physical examination or symptoms suggestive of active cancer. 4. Subjects must have initiated adjuvant chemotherapy no more than 8 weeks following primary debulking surgery. 5. Successful manufacturing of at least 4 doses (vials) of Vigil and placebo. 6. Recovered from all clinically relevant toxicities related to prior therapy (including neuropathy ≤Grade 2). 7. ECOG performance status (PS) 0-1. 8. Normal organ and marrow function as defined below: Absolute granulocyte count ≥ 1,500/mm\^3, Absolute lymphocyte count ≥ 500/mm\^3, Platelets ≥ 75,000/mm\^3, Total bilirubin ≤ 2 mg/dL, AST(SGOT)/ALT(SGPT)≤ 2x institutional upper limit of normal, Creatinine \< 1.5 mg/dL 9. Ability to understand and the willingness to sign a written informed protocol specific consent. 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): 1. Surgery involving general anesthesia, radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to randomization. 2. Histologically confirmed papillary serous adenocarcinoma of the uterus or disease involving myometrium/endometrium. 3. Systemic immunosuppressive therapy within 14 days of randomization. 4. 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. 5. 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). 6. Psychiatric illness/social situations that would limit compliance with study requirements. 7. Subjects with history of brain metastases. 8. Subjects with known HIV or chronic Hepatitis B or C infection. 9. Prior solid organ or bone marrow transplant. 10. 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.

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
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
Franciscan Research Center Tacoma Washington

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02346747 on ClinicalTrials.gov ↗ ← All trials in the USA