A Trial of Vigil for Participants With Ovarian Cancer

NCT02346747 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CL-PTL-119
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 26

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?"

Conditions

Ovarian Cancer; Ovarian Neoplasms

Keywords

Stage III; Stage IV; Ovarian Cancer; Maintenance; Immunotherapy; primary peritoneal cancer; fallopian tube cancer; endometrioid ovarian cancer; high-grade serous ovarian cancer

Outcome Measures

Primary Outcomes (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.

  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)

• Overall survival (OS)

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

Study Arms (2)

Group A

ACTIVE COMPARATOR

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.

Biological: Vigil

Group B

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Vigil BIOLOGICAL

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.

Also known as: bi-shRNAfurin and GMCSF Autologous Tumor Cell Immunotherapy, FANG vaccine

Group A

Placebo OTHER

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.

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gradalis, Inc.: lead

Study Sites (26)

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36604, United States

Location

Southern California Permanente Medical Group

Irvine, California, 92618, United States

Location

Palo Alto Foundation Medical Group

San Francisco, California, 94115, United States

Location

University Of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Florida Cancer Specialists

West Palm Beach, Florida, 33401, United States

Location

Georgia Cancer Center at Augusta University

Augusta, Georgia, 30912, United States

Location

University Of Kentucky Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

Maine Medical Center: MMP Women's Health

Scarborough, Maine, 04074, United States

Location

Dana Farber Cancer Institute: Gynecologic Oncology

Boston, Massachusetts, 02215, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Billings Clinic

Billings, Montana, 59101, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Duke University Medical Center, Department of Medicine - Oncology

Durham, North Carolina, 27710, United States

Location

Barrett Cancer Center University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

Stephenson Cancer Center at University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

AMD Asplundh Cancer Pavilion

Abington, Pennsylvania, 19001, United States

Location

St. Luke's Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Prisma Health Cancer Institute

Greenville, South Carolina, 29605, United States

Location

Mary Crowley Cancer Research Centers

Dallas, Texas, 75230, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9032, United States

Location

Cancer Care Northwest

Spokane, Washington, 99216, United States

Location

Franciscan Research Center

Tacoma, Washington, 98405, United States

Location

Related Publications (8)

• 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.

  PMID: 22186789 BACKGROUND

• 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.

  PMID: 24968881 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 27109631 BACKGROUND

• 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.

  PMID: 25917459 BACKGROUND

• 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.

  PMID: 33364285 BACKGROUND

• 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.

  PMID: 33271095 RESULT

• 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.

  PMID: 33715892 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

FANG vaccine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Study Officials

• John Nemunaitis, MD

  Gradalis, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: January 27, 2015
• Study Start: February 1, 2015
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (26)