A Trial of Vigil for Participants With Ovarian Cancer
- Conditions
- Ovarian NeoplasmsOvarian Cancer
- Interventions
- Other: PlaceboBiological: Vigil
- Registration Number
- NCT02346747
- Lead Sponsor
- Gradalis, Inc.
- Brief 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?"
- Detailed 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 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 eligible for randomization will have achieved a clinically defined complete response following primary surgery and adjuvant chemotherapy. Clinical complete response (cCR) is defined as no evidence of maligancy on chest x-ray and CT scan or MRI of the abdomen and pelvis, CA-125 antigen level ≤ units/mL, and no findings on physical examination or symptoms suggestive of active cancer.
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 to Group A (Vigil 1.0 X 10e7 cells/injection) or Group B (placebo). Randomization will be stratified by (i) extent of surgical cytoreduction (complete/microscopic versus macroscopic residual disease) and (ii) neoadjuvant versus adjuvant chemotherapy. Participants will receive Vigil or placebo by intradermal injection once a month for at least 4 and up to a maximum of 6 doses determined by the number of doses of Vigil manufactured for that subject.
Participants will be managed in an outpatient setting. Image assessment with chest x-ray and CT scan or MRI of the abdomen and pelvis will be completed every 3 months in Years 1-3, then every 6 months in Years 4 and 5 and yearly through Year 10. At the time the participant recurs, the participant will enter long term follow-up for survival status and post treatment therapies received.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 92
Not provided
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B Placebo Placebo will be administered via intradermal injection every 4 weeks for a minimum of 4 and a maximum of 6 administrations as determined by the number of doses manufactured and as long as the subject is clinically stable and recurrence free. Group A Vigil Vigil immunotherapy will be administered at a concentration of 1.0 x 10e7 cells/dose given via intradermal injection every 4 weeks for a minimum of 4 and a maximum of 6 administrations as determined by the number of doses manufactured and as long as the subject is clinically stable and recurrence free.
- Primary Outcome Measures
Name Time Method Recurrence Free Survival (RFS) Time from randomization date to either the date of first recurrence or the date of death if the participant dies prior to recurrence, assessed up to 10 years. Disease recurrence will be evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by local and central radiology. RFS is defined as the time from randomization or from surgery/procurement to the event of disease recurrence/progression or death due to any cause.
- Secondary Outcome Measures
Name Time Method Overall survival (OS) OS will be evaluated from time of randomization until date of death can be obtained, assessed up to 10 years. OS is defined as the time from randomization to date of death due to any cause.
Trial Locations
- Locations (26)
Florida Cancer Specialists
🇺🇸West Palm Beach, Florida, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Mary Crowley Cancer Research Centers
🇺🇸Dallas, Texas, United States
Maine Medical Center: MMP Women's Health
🇺🇸Scarborough, Maine, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Dana Farber Cancer Institute: Gynecologic Oncology
🇺🇸Boston, Massachusetts, United States
University Of Miami Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Barrett Cancer Center University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Prisma Health Cancer Institute
🇺🇸Greenville, South Carolina, United States
Palo Alto Foundation Medical Group
🇺🇸San Francisco, California, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Duke University Medical Center, Department of Medicine - Oncology
🇺🇸Durham, North Carolina, United States
Stephenson Cancer Center at University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
University of South Alabama Mitchell Cancer Institute
🇺🇸Mobile, Alabama, United States
Southern California Permanente Medical Group
🇺🇸Irvine, California, United States
University Of Kentucky Markey Cancer Center
🇺🇸Lexington, Kentucky, United States
Georgia Cancer Center at Augusta University
🇺🇸Augusta, Georgia, United States
Billings Clinic
🇺🇸Billings, Montana, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
AMD Asplundh Cancer Pavilion
🇺🇸Abington, Pennsylvania, United States
St. Luke's Health Network
🇺🇸Bethlehem, Pennsylvania, United States
Cancer Care Northwest
🇺🇸Spokane, Washington, United States
Franciscan Research Center
🇺🇸Tacoma, Washington, United States
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States