Cvac as Maintenance Treatment in Patients With EOC in Complete Remission Following First-Line Chemotherapy (CANVAS)

• Overall survival (OS) [ Time Frame: Participants will be followed from randomization until the date of death from any cause or end of study, whichever comes first, assesessed up to 156 weeks. ] [ Designated as safety issue: No ]
  Assess Cvac as compared to placebo for overall survival
• Assessment of safety and tolerability of Cvac as compared to placebo [ Time Frame: 10 - 12 months ] [ Designated as safety issue: Yes ]
  Evaluated by AEs, laboratory test results, ECGs, physical examinations, and vital signs
• Assessment of health-related quality of life questionnaires(QoL) [ Time Frame: From baseline and throughout PFS up to 156 weeks ] [ Designated as safety issue: No ]
  Quality-of-life data will be derived from the quality of life questionnaires according to the corresponding scoring manuals and will be summarized for each treatment group. Patients' health states will be derived from the EQ-5D-3L questionnaire. Data will be summarized by treatment group and analyzed using descriptive statistics.

• Overall survival (OS) [ Time Frame: Participants will be followed from randomization until the date of death from any cause or end of study, whichever comes first, assesessed up to 156 weeks. ] [ Designated as safety issue: No ]
  Assess Cvac as compared to placbo for overall survival
• Assessment of safety and tolerability of Cvac as compared to placebo [ Time Frame: 10 - 12 months ] [ Designated as safety issue: Yes ]
  Evaluated by AEs, laboratory test results, ECGs, physical examinations, and vital signs
• Assessment of health-related quality of life questionnaires(QoL) [ Time Frame: From baseline and throughout PFS up to 156 weeks ] [ Designated as safety issue: No ]
  Quality-of-life data will be derived from the quality of life questionnaires according to the corresponding scoring manuals and will be summarized for each treatment group. Patients' health states will be derived from the EQ-5D-3L questionnaire. Data will be summarized by treatment group and analyzed using descriptive statistics.

The purpose of this study is to determine if an investigational cell therapy called Cvac can help prevent EOC from returning when administered to patients who are in complete remission after surgical removal of their tumor followed by standard first-line chemotherapy.

Following surgery and study randomization, patients will undergo leukapheresis for manufacture of the study agent and then begin first-line chemotherapy. After completion of chemotherapy and confirmation of complete remission, patients will enter the treatment phase of the study.

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 survival.

• Biological: Placebo Study Agent
  Study agent will be administered via intradermal injection, every 4 weeks for the first 3 doses and thereafter every 12 weeks for 3 additional doses
• Biological: Cvac
  Study agent dosing will be administered as an intradermal injection every 4 weeks for the first 3 doses, then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.

• Placebo Comparator: Placebo
  Intervention: Biological: Placebo Study Agent
• Active Comparator: Cvac
  Cvac as compared with placebo for the maintenance treatment of patients with EOC in CR following first line chemotherapy
  Intervention: Biological: Cvac

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• Chi DS, Eisenhauer EL, Lang J, Huh J, Haddad L, Abu-Rustum NR, Sonoda Y, Levine DA, Hensley M, Barakat RR. What is the optimal goal of primary cytoreductive surgery for bulky stage IIIC epithelial ovarian carcinoma (EOC)? Gynecol Oncol. 2006 Nov;103(2):559-64. Epub 2006 May 22.
• Katsumata N, Yasuda M, Takahashi F, Isonishi S, Jobo T, Aoki D, Tsuda H, Sugiyama T, Kodama S, Kimura E, Ochiai K, Noda K; Japanese Gynecologic Oncology Group. Dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer: a phase 3, open-label, randomised controlled trial. Lancet. 2009 Oct 17;374(9698):1331-8. Epub 2009 Sep 18.

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 chemotherapy
• 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 investigator

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