Cvac as Maintenance Treatment in Patients With Epithelial Ovarian Cancer in Complete Remission Following First-line Chemotherapy or Second-line Treatment

Inclusion Criteria

• •Part A: First Remission
• •1. Females ≥ 18 years of age at screening with a confirmed diagnosis of Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube cancer.
• •2. Undergone optimal debulking surgery, defined as ≤ 1 cm of residual tumor.
• •3. Undergone standard platinum and taxane first-line chemotherapy.
• •4. Signed an informed consent form (ICF).
• •5. Completed study procedures within the study timelines.
• •6. Mucin 1-positive tumor as determined by central immunohistopathology.
• •7. Adequate renal function in the opinion of the investigator based on serum creatinine and/or glomerular filtration rate.
• •8. Adequate liver function, defined as 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, unless Gilbert's syndrome had been previously confirmed for the patient.
• •9. Adequate bone marrow function, defined as 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.
• •10. Life expectancy of at least 12 months at the time of screening as judged by the investigator.
• •11. Not pregnant, and if of childbearing potential, agreed 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.
• •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 computed tomography (CT) or magnetic resonance imaging (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 (ie, 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, ie, 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, defined as serum creatinine ≤ 1.5 × ULN.
• •3. Adequate liver function, defined as 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. Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 (applicable at the baseline visit only).