Cvac as Maintenance Treatment in Patients With EOC in Complete Remission Following First-Line Chemotherapy or Second-Line Treatment

This study proposes a nontoxic immunotherapeutic approach to extend the overall survival in
patients in complete remission.

Most patients with ovarian cancer achieve complete clinical remission after optimal
debulking surgery and first-line platinum-based chemotherapy. However, most patients,
despite high response rates to first-line treatment, will relapse and undergo subsequent
lines of chemotherapy. Generally, the progression-free interval between treatments becomes
shorter with each relapse, and the patient eventually dies of the disease.

Part A - First Remission: Closed to Recruitment

Part B - Second Remission: Open to Recruitment

Inclusion Criteria (Part B):

1. Females ≥ 18 years of age at screening with a confirmed diagnosis of epithelial
ovarian, fallopian tube, or peritoneal cancer

2. Underwent standard cytoreductive surgery and first-line chemotherapy containing
platinum before first relapse and were in complete remission for at least 6 months
prior to relapse

3. Relapsed once and then underwent standard platinum-based second-line chemotherapy (at
least 3 cycles is required) with or without a second bulk-reducing surgery

4. Second remission defined as:

1. No definitive evidence of disease (NED) on CT or MRI of the abdomen and pelvis;

2. CA-125 ≤ upper limit of normal (ULN) or 90% reduction in CA-125 since start of
second-line chemotherapy;

3. Negative physical exam (i.e., no clinical signs)

5. Life expectancy ≥ 3 months in the opinion of the investigator

6. Signed an informed consent form (ICF)

7. Willing and able to complete study procedures within the expected study timelines

8. Mucin 1-positive tumor as determined by central immunohistopathology

9. Histologically documented EOC, fallopian tube, or peritoneal cancer (patients with
pseudomyxoma, mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine
histology, with borderline ovarian cancer, i.e., patients with low malignant
potential tumors, and with clear cell or mucinous histology are excluded)

10. Adequate end-organ and hematological function as defined by:

1. Adequate bone marrow function: white blood cells (WBCs) ≥ 3.0 K/µL, absolute
neutrophil count (ANC) ≥ 1.5 × 109

- L, hemoglobin ≥ 9 g/dL, and platelets

≥ 100 × 109

- L

2. Adequate renal function: serum creatinine ≤ 1.5 × ULN

3. Adequate liver function: serum glutamic oxaloacetic transaminase/aspartate
aminotransferase (SGOT/AST) and serum glutamic pyruvic transaminase/alanine
aminotransferase (SGPT/ALT) ≤ 2 × ULN and serum bilirubin ≤ 1.5 × ULN

11. Generally well-controlled blood pressure with systolic blood pressure ≤ 140 mmHg and
diastolic blood pressure ≤ 90 mmHg prior to randomization (antihypertensive
medications are permitted). Low-dose chronic hormonal or steroidal treatments are
also permitted.

12. Not pregnant, and if of childbearing potential, agrees to use a highly effective
method of birth control (implanted, injectable, or oral combination hormonal method
alone or in possible combinations, intrauterine device, vasectomized partner, or
abstinence) prior to study entry, for the duration of the study, and for 3 months
after the last dose of study agent. Male partners of a study patient must use a
condom in addition to the acceptable method of contraception for the female partner
as specified above

13. ECOG status of 0 or 1 (applicable at the baseline visit only).

Exclusion Criteria (Part B):

Patients are to be excluded from the study at the time of screening and the baseline visit
(defined as the visit within 2 weeks of the first dose) for any of the following reasons:

1. More than 2 previous lines of chemotherapy for EOC, fallopian tube, or peritoneal
cancer

2. Primary platinum-refractory or platinum-resistant disease (i.e., patients who
progress prior to cessation of induction therapy [platinum refractory] or recur
within 6 months after cessation [platinum resistant])

3. Treatment with any investigational product (for any condition) within 4 weeks of
screening. Enrolled in or has not completed at least 28 days (prior to screening)
since ending another investigational device or drug treatment, or currently receiving
other investigational treatments

4. Concurrent systemic treatment with steroids or other immunosuppressant agents at a
dose considered by the investigator to be higher than a standard physiological dose

5. Evidence of severe or uncontrolled cardiac disease, including myocardial infarction
or unstable angina within 6 months of screening, congestive heart failure, or
ventricular arrhythmias requiring medication

6. Diagnosed immunodeficiency or autoimmune disorder

7. Infection with human immunodeficiency virus (HIV) or hepatitis C virus (HCV), or
active and infectious hepatitis B virus (HBV) infection

8. Pregnant or lactating

9. Evidence or history of central nervous system metastasis

10. Known hypersensitivity to any of the components of the study agent

11. Any unresolved persistent toxicities from prior systemic therapy that are either
Grade 3 or Grade 4 (except alopecia) per the Common Terminology Criteria for Adverse
Events (CTCAE) version 4.0

12. Intent to treat patient with both an anti-angiogenesis therapy (such as bevacizumab)
and a PARP inhibitor as part of maintenance therapy. Only one or the other are
permitted while the patient is on study and must be started between the baseline
visit and Visit 1 if it will be used as part of the patient's maintenance therapy
regimen.