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

• Progression-free survival (PFS) for maintenance treatment of patients with EOC in complete remission following first-line chemotherapy [ 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 ] [ Designated as safety issue: No ]
  PFS is defined as the time from randomization to the date of radiological scan used to determine PD, evaluated every 8 weeks after baseline.
  
  

• 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.
  
  

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.