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Ovarian CancerPhase 2VITALNCT02346747

A Trial of Vigil for Participants With Ovarian Cancer

A Phase 2 study testing Vigil in people with Ovarian Cancer and Ovarian Neoplasms, run by Gradalis, Inc. at 26 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer, Ovarian Neoplasms
What is being tested?
Vigil
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
92 participants
Where
26 sitesUnited States
Study dates
Feb 2015to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects will be eligible for tissue procurement for the Vigil manufacturing process if they meet all of the following criteria:
  • Presumptive Stage IIIb, IIIc or IV high-grade papillary serous/clear cell/endometrioid ovarian, fallopian tube or primary peritoneal cancer.
  • No chemotherapy prior or investigational agents prior to tissue acquisition for Vigil manufacture.
  • No other malignancy (excluding surgically cured nonmelanoma carcinomas of the skin and carcinoma in situ cervix) unless in remission for ≥ 2 years.
  • 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.
  • ECOG performance status (PS) 0-2 prior to diagnostic laparoscopy or debulking laparotomy.
Show all 20Show fewer
  • No prior history of hypersensitivity reactions (HSR) with taxanes or platinums.
  • No prior history of allergies or sensitivities to gentamicin.
  • Female, 18 years of age or older.
  • 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:
  • Histologically confirmed Stage IIIb, IIIc or IV high-grade papillary serous/clear cell/endometrioid ovarian, fallopian tube or primary peritoneal.
  • 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.
  • 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.
  • Subjects must have initiated adjuvant chemotherapy no more than 8 weeks following primary debulking surgery.
  • Successful manufacturing of at least 4 doses (vials) of Vigil and placebo.
  • Recovered from all clinically relevant toxicities related to prior therapy (including neuropathy ≤Grade 2).
  • ECOG performance status (PS) 0-1.
  • 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
  • Ability to understand and the willingness to sign a written informed protocol specific consent.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

United States26 sites

  • AMD Asplundh Cancer Pavilion

    Abington, Pennsylvania, 19001

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912

  • St. Luke's Health Network

    Bethlehem, Pennsylvania, 18015

  • Billings Clinic

    Billings, Montana, 59101

  • Dana Farber Cancer Institute: Gynecologic Oncology

    Boston, Massachusetts, 02215

  • Barrett Cancer Center University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • Mary Crowley Cancer Research Centers

    Dallas, Texas, 75230

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-9032

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center, Department of Medicine - Oncology

    Durham, North Carolina, 27710

  • Prisma Health Cancer Institute

    Greenville, South Carolina, 29605

  • Southern California Permanente Medical Group

    Irvine, California, 92618

  • Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756

  • University Of Kentucky Markey Cancer Center

    Lexington, Kentucky, 40536

  • University Of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36604

  • Stephenson Cancer Center at University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Palo Alto Foundation Medical Group

    San Francisco, California, 94115

  • Maine Medical Center: MMP Women's Health

    Scarborough, Maine, 04074

  • Cancer Care Northwest

    Spokane, Washington, 99216

  • Franciscan Research Center

    Tacoma, Washington, 98405

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401

Other trials in United States

About this study

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

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?"

Read the 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.

Being tested
Vigil, Placebo
Keywords
Stage III, Stage IV, Ovarian Cancer, Maintenance, Immunotherapy, primary peritoneal cancer, fallopian tube cancer, endometrioid ovarian cancer, high-grade serous ovarian cancer
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VigilBiological

    Also called bi-shRNAfurin and GMCSF Autologous Tumor Cell Immunotherapy, FANG vaccine

    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.

  • PlaceboOther

    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 groups in NCT02346747
Study groupRoleWhat they receive
Group AActive comparatorVigil 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.
Receives: Biological: Vigil
Group BPlacebo comparatorPlacebo 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.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence Free Survival (RFS)

    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.

    Measured: 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.

Secondary outcomes (1)

  1. Overall survival (OS)

    OS is defined as the time from randomization to date of death due to any cause.

    Measured: OS will be evaluated from time of randomization until date of death can be obtained, assessed up to 10 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02346747
Sponsor's protocol ID
CL-PTL-119
Acronym
VITAL
Status last verified
Oct 2025
First submitted
21 Jan 2015
Last updated
29 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Senzer N, Barve M, Kuhn J, Melnyk A, Beitsch P, Lazar M, Lifshitz S, Magee M, Oh J, Mill SW, Bedell C, Higgs C, Kumar P, Yu Y, Norvell F, Phalon C, Taquet N, Rao DD, Wang Z, Jay CM, Pappen BO, Wallraven G, Brunicardi FC, Shanahan DM, Maples PB, Nemunaitis J. Phase I trial of "bi-shRNAi(furin)/GMCSF DNA/autologous tumor cell" vaccine (FANG) in advanced cancer. Mol Ther. 2012 Mar;20(3):679-86. doi: 10.1038/mt.2011.269. Epub 2011 Dec 20.

    PubMed 22186789

  • Nemunaitis J, Barve M, Orr D, Kuhn J, Magee M, Lamont J, Bedell C, Wallraven G, Pappen BO, Roth A, Horvath S, Nemunaitis D, Kumar P, Maples PB, Senzer N. Summary of bi-shRNA/GM-CSF augmented autologous tumor cell immunotherapy (FANG) in advanced cancer of the liver. Oncology. 2014;87(1):21-9. doi: 10.1159/000360993. Epub 2014 Jun 25.

    PubMed 24968881

  • Senzer N, Barve M, Nemunaitis J, Kuhn J, Melnyk A, et al. (2013) Long Term Follow Up: Phase I Trial of "Bi-Shrnafurin/GMCSF DNA/Autologous Tumor Cell" Immunotherapy (FANG™) in Advanced Cancer. J Vaccines Vaccin 4:209. doi: 10.4172/2157-7560.1000209

  • Ghisoli M, Barve M, Mennel R, Lenarsky C, Horvath S, Wallraven G, Pappen BO, Whiting S, Rao D, Senzer N, Nemunaitis J. Three-year Follow up of GMCSF/bi-shRNA(furin) DNA-transfected Autologous Tumor Immunotherapy (Vigil) in Metastatic Advanced Ewing's Sarcoma. Mol Ther. 2016 Aug;24(8):1478-83. doi: 10.1038/mt.2016.86. Epub 2016 Apr 25.

    PubMed 27109631

  • Ghisoli M, Barve M, Schneider R, Mennel R, Lenarsky C, Wallraven G, Pappen BO, LaNoue J, Kumar P, Nemunaitis D, Roth A, Nemunaitis J, Whiting S, Senzer N, Fletcher FA, Nemunaitis J. Pilot Trial of FANG Immunotherapy in Ewing's Sarcoma. Mol Ther. 2015 Jun;23(6):1103-1109. doi: 10.1038/mt.2015.43. Epub 2015 Mar 19.

    PubMed 25917459

  • Oh J, Barve M, Senzer N, Aaron P, Manning L, Wallraven G, Bognar E, Stanbery L, Horvath S, Manley M, Nemunaitis J, Walter A, Rocconi RP. Long-term follow-up of Phase 2A trial results involving advanced ovarian cancer patients treated with Vigil(R) in frontline maintenance. Gynecol Oncol Rep. 2020 Sep 17;34:100648. doi: 10.1016/j.gore.2020.100648. eCollection 2020 Nov. No abstract available.

    PubMed 33364285

  • Rocconi RP, Grosen EA, Ghamande SA, Chan JK, Barve MA, Oh J, Tewari D, Morris PC, Stevens EE, Bottsford-Miller JN, Tang M, Aaron P, Stanbery L, Horvath S, Wallraven G, Bognar E, Manning L, Nemunaitis J, Shanahan D, Slomovitz BM, Herzog TJ, Monk BJ, Coleman RL. Gemogenovatucel-T (Vigil) immunotherapy as maintenance in frontline stage III/IV ovarian cancer (VITAL): a randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Oncol. 2020 Dec;21(12):1661-1672. doi: 10.1016/S1470-2045(20)30533-7.

    PubMed 33271095

  • Rocconi RP, Monk BJ, Walter A, Herzog TJ, Galanis E, Manning L, Bognar E, Wallraven G, Stanbery L, Aaron P, Senzer N, Coleman RL, Nemunaitis J. Gemogenovatucel-T (Vigil) immunotherapy demonstrates clinical benefit in homologous recombination proficient (HRP) ovarian cancer. Gynecol Oncol. 2021 Jun;161(3):676-680. doi: 10.1016/j.ygyno.2021.03.009. Epub 2021 Mar 11.

    PubMed 33715892

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vigil in people with Ovarian Cancer and Ovarian Neoplasms, run by Gradalis, Inc. at 26 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence Free Survival (RFS) (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02346747, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.

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