Cvac as Maintenance Treatment in Patients With EOC in Complete Remission Following First-Line Chemotherapy (CANVAS)
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.
Epithelial Ovarian Cancer
Biological: Placebo Study Agent
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||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|
- 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.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
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
Active Comparator: Cvac
Cvac as compared with placebo for the maintenance treatment of patients with EOC in CR following first line chemotherapy
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.
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.
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