A Trial of Vigil for Participants With Ovarian Cancer

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?"

Key Facts

Interventions

Conditions

Eligibility

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.

Outcome Measures

Locations

Linked Diseases

Linked Papers