Efficacy Multicentre Trial of ImmunoTherapy Vaccination With Abagovomab to Treat Ovarian Cancer Patients

Inclusion Criteria: At a maximum of 12 weeks after the last cycle of first line standard platinum/taxaneintravenous (IV) or intraperitoneal (IP) chemotherapy, patients must fulfill all thefollowing inclusion criteria:

• Age >/= 18 years;

• Properly executed written informed consent;

• History of histological and CA125 (> 35 U/ml) confirmed diagnosis of stage III-IVepithelial ovarian, fallopian tube, or primary peritoneal cancer;

• History of debulking surgery and 6-8 cycles of standard platinum/taxane basednon-investigational IV-IP chemotherapy;

• Complete clinical response defined as:

• Normal physical examination;

• No symptoms suggestive of persistent cancer;

• No definite evidence of disease by computed tomography (CT) of the abdomen and pelviswithin the previous 4 weeks;

• Negative chest x-ray (or chest CT scan) within the previous 4 weeks;

• Serum CA125 within the normal laboratory range.

• Adequate hematologic, renal and hepatic function:

• Absolute Neutrophil Count (ANC) >/=1.5 * 109/l;

• Platelets >/= 75 * 109/l;

• Haemoglobin >/= 6.2 mmol/l (>9.9 g/dl);

• Serum creatinine </= 1.5 * ULN (Upper Limit of Normal);

• Bilirubin </= 1.5 * ULN; AST, ALT, AP </= 2.5 * ULN.

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) </= 2.

Exclusion Criteria: Patients are ineligible to participate in the study, if any of the following criteria arepresent:

• any other invasive malignancies, with the exception of non-melanoma skin cancer orcervical carcinoma in situ, within the last 5 years or whose previous cancer treatmentcontraindicates this protocol therapy;

• known active autoimmune disease requiring chronic treatment with immunosuppressiveagents (e.g., rheumatoid arthritis, ulcerative colitis, etc.);

• known immune deficiency (e.g. HIV, hypogammaglobulinemia, etc.);

• known infection with hepatitis B, or hepatitis C;

• history of recent myocardial infarction (</= 6 months) or decompensated heart failure (New York Heart Association - NYHA class >/= III);

• previous or concomitant use of any anti-cancer therapy other than the platinum-taxanebased 1st line chemotherapy for ovarian cancer; any maintenance or consolidationtherapy is not permitted after completion of standard front line chemotherapy.

• concomitant use of any other investigational agent;

• any prior investigational anti-cancer vaccine or monoclonal antibody;

• known allergy to murine proteins;

• any significant medical or psychiatric condition, drug or alcohol abuse that mightprevent the patient from complying with all study procedures;

• clinically significant active infection;

• concomitant use of any immunosuppressive agent (e.g., steroids, cyclosporin, etc.);

• major surgery within the previous 2 weeks;

• radiotherapy within the previous 4 weeks;

• any significant toxicity from prior chemotherapy;

• unreliability or inability to follow protocol requirements;

• potentially childbearing and not willing to use adequate contraceptive methodsthroughout the entire study period;

• pregnancy.