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Ovarian cancer vaccine trial aims to keep tumors at bay

NCT ID NCT02346747

Disease control Sponsor: Gradalis, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a personalized immunotherapy called Vigil in 92 women with advanced ovarian cancer who are currently cancer-free after surgery and chemotherapy. The treatment uses the patient's own tumor cells to create a vaccine that trains the immune system to fight any remaining cancer cells. The main goal is to see if Vigil can delay the cancer from coming back compared to a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

92 people

The number who actually took part.

Started

Feb 2015

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

fallopian tube cancer fallopian tube neoplasm ovarian cancer ovarian neoplasm primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ovarian cancer Ovarian neoplasms

Contacts and locations

Locations

  • AMD Asplundh Cancer Pavilion

    Abington, Pennsylvania, 19001, United States

  • Barrett Cancer Center University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

  • Billings Clinic

    Billings, Montana, 59101, United States

  • Cancer Care Northwest

    Spokane, Washington, 99216, United States

  • Dana Farber Cancer Institute: Gynecologic Oncology

    Boston, Massachusetts, 02215, United States

  • Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756, United States

  • Duke University Medical Center, Department of Medicine - Oncology

    Durham, North Carolina, 27710, United States

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Franciscan Research Center

    Tacoma, Washington, 98405, United States

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Maine Medical Center: MMP Women's Health

    Scarborough, Maine, 04074, United States

  • Mary Crowley Cancer Research Centers

    Dallas, Texas, 75230, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114, United States

  • Palo Alto Foundation Medical Group

    San Francisco, California, 94115, United States

  • Prisma Health Cancer Institute

    Greenville, South Carolina, 29605, United States

  • Southern California Permanente Medical Group

    Irvine, California, 92618, United States

  • St. Luke's Health Network

    Bethlehem, Pennsylvania, 18015, United States

  • Stephenson Cancer Center at University of Oklahoma

    Oklahoma City, Oklahoma, 73104, United States

  • University Of Kentucky Markey Cancer Center

    Lexington, Kentucky, 40536, United States

  • University Of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136, United States

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106, United States

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36604, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-9032, United States

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