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A Randomised,Double Blind, Placebo Controlled, Multicentre Trial of Abagovomab Maintenance Therapy in Patients With Epithelial Ovarian Cancer After Complete Response to First Line Chemotherapy

Phase 2/Phase 3
18 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

A Randomised,Double Blind, Placebo Controlled, Multicentre Trial of Abagovomab Maintenance Therapy in Patients With Epithelial Ovarian Cancer After Complete Response to First Line Chemotherapy

Standard initial treatment of ovarian cancer patients includes both surgery and chemotherapy
which in the vast majority of cases achieves the disappearance of ovarian cancer lesions.
This status, called "clinical remission" which means having no evidence of cancer on CT scan
or physical examination needs to be carefully follow up in order to confirm the maintenance
of the remission status or to early detect if the cancer grows again and then start a new
chemotherapy. At present, no approved therapies exist for the maintenance treatment of
patients who achieved the clinical remission.

This trial aims to evaluate if the repeated vaccination with Abagovomab creates an
immunoresponse which is able to fight the cancer cells thus keeping the remission status as
long as possible and help patients live disease-free and longer.

Patients who achieve the remission status after chemotherapy will be screened for study
participation and if they meet the criteria for inclusion they will start to receive a
single subcutaneous injection every 2 weeks (for the first 4 doses - induction phase) and
then every 4 weeks (maintenance phase). The duration of treatment is up to approximately 4
years or it will be stopped in case relapse occurs.

In order to evaluate the real benefit of vaccination, the experimental treatment includes
Abagovomab (the active drug) or placebo (the vehicle only, without drug), with a double
chance to receive Abagovomab. Assignment of Abagovomab or placebo will be done by a
computerised system and nobody in the study will know which treatment has been allocated
until study end.

Patients will be visited every 4 weeks and will undergo CT scan of pelvis and abdomen every
12 weeks in order to confirm the remission status or to early detect if relapse eventually
occurs. This will be done in blind condition (i.e. without being aware which treatment the
patient is going to receive) for the first part of the study which is expected to last four
years. After then the overall status of patient will continue to be monitored by phone
contact for additional five years.

Inclusion Criteria:

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

- Age >/= 18 years;

- Properly executed written informed consent;

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

- History of debulking surgery and 6-8 cycles of standard platinum/taxane based
non-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 pelvis
within 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
- Bilirubin
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Exclusion Criteria:

Patients are ineligible to participate in the study, if any of the following criteria are

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

- known active autoimmune disease requiring chronic treatment with immunosuppressive
agents (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 ( (New York Heart Association - NYHA class >/= III);

- previous or concomitant use of any anti-cancer therapy other than the platinum-taxane
based 1st line chemotherapy for ovarian cancer; any maintenance or consolidation
therapy 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 might
prevent 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 methods
throughout the entire study period;

- pregnancy.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Recurrence Free Survival Evaluated by Clinical Event Adjudication Committee (CEAC)

Outcome Description:

The Recurrence free survival correspond to the time from date of randomization to documented disease recurrence or death. Disease recurrence is defined as the appearance of any lesion or development of tumor-related symptoms evaluated by medical examination and must be confirmed by a documented CT scan.

Outcome Time Frame:

Every 12 weeks up to recurrence or up to 3 months after last administered dose

Safety Issue:


Principal Investigator

Jacobus Pfisterer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

AGO-OVAR, Ovarian Cancer Study Group, Germany; Ubbo-Emmius-Klinik gGmbH Aurich, Germany


United States: Food and Drug Administration

Study ID:




Start Date:

December 2006

Completion Date:

June 2011

Related Keywords:

  • Ovarian Cancer
  • Ovarian cancer
  • Abagovomab
  • Ovarian Neoplasms



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