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A Randomized, Double-Blinded, Placebo-Controlled Trial of Cvac as Maintenance Treatment in Patients With Epithelial Ovarian Cancer in Complete Remission Following First-Line Chemotherapy

Phase 2
18 Years
Open (Enrolling)
Epithelial Ovarian Cancer

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Trial Information

A Randomized, Double-Blinded, Placebo-Controlled Trial of Cvac as Maintenance Treatment in Patients With Epithelial Ovarian Cancer in Complete Remission Following First-Line Chemotherapy

This study proposes a nontoxic immunotherapeutic approach to extend the progression free
interval following first-line treatment in patients in complete remission.

Most patients with ovarian cancer achieve complete clinical remission after optimal
debulking surgery and 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. The ability to increase
the progression-free intervals between chemotherapeutic treatments would have a significant
benefit to a patient's quality of life and would potentially lead to longer overall

Inclusion Criteria:

- A confirmed diagnosis of Stage III or IV epithelial ovarian, primary peritoneal, or
fallopian tube cancer

- Have undergone optimal debulking surgery, defined as ≤ 1 cm of residual tumor

- Eligible for, and plan to undergo standard platinum and taxane first-line

- Mucin 1-positive tumor as determined by central immunohistopathology

- Adequate renal function

- Adequate liver function

- Adequate bone marrow function

- Life expectancy of at least 12 months at the time of screening as judged by the

Exclusion Criteria:

- Non-epithelial ovarian cancer, including ovarian germ cell, sarcoma, mixed Mullerian
tumors, or mucinous carcinoma of the peritoneum

- Malignancy other than EOC, except those that have been in CR for a minimum of 3
years, and except carcinoma in-situ of the cervix or basal cell and squamous cell
carcinomas of the skin that have been adequately treated

- Evidence of severe or uncontrolled cardiac disease

- Active uncontrolled infection

- Uncontrolled hypertension

- Diagnosed immunodeficiency or autoimmune disorder

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival (PFS) for maintenance treatment of patients with EOC in complete remission following first-line chemotherapy

Outcome Description:

PFS is defined as the time from randomization to the date of radiological scan used to determine PD, evaluated every 8 weeks after baseline.

Outcome Time Frame:

From date of randomization until the date of first documented progression, date of death from any cause, or end of study, whichever comes first, assessed up to 156 weeks

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2012

Completion Date:

December 2015

Related Keywords:

  • Epithelial Ovarian Cancer
  • EOC
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial



Cleveland Clinic Foundation Cleveland, Ohio  44195
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
California Cancer Center Fresno, California  93720
Sarasota Memorial Hospital Sarasota, Florida  34239
Stanford University School of Medicine Stanford, California  94305-5317
University of California, San Francisco San Francisco, California  94143
University of Chicago Medical Center Chicago, Illinois  60637
Memorial Health University Medical Center Savannah, Georgia  31404
LAC-USC Medical Center Los Angeles, California  90033
Swedish Cancer Center Seattle, Washington  98122
Collaborative Research Group Boynton Beach, Florida  33435
Innovative Clinical Research Institute Downey, California  90241
St Joseph Hospital Orange, California  92868
University Gynecologic Oncology Atlanta, Georgia  30342
Women`s Cancer Center Morristown, New Jersey  07962
Portland Medical Group Portland, Oregon  97213