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Trial record 1 of 1 for:    CAN-004
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Cvac as Maintenance Treatment in Patients With Epithelial Ovarian Cancer in Complete Remission Following First-line Chemotherapy or Second-line Treatment (CANVAS)

This study has been terminated.
(The study was terminated due to company restructuring and changes in drug development priorities.)
Sponsor:
Information provided by (Responsible Party):
Prima BioMed Ltd
ClinicalTrials.gov Identifier:
NCT01521143
First received: January 17, 2012
Last updated: December 9, 2016
Last verified: December 2016
Results First Received: November 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Epithelial Ovarian Cancer
Interventions: Biological: Cvac
Biological: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Different participants were enrolled in the 2 parts of the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Part A - Cvac Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
Part A - Placebo Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
Part B - Cvac Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
Part B - Observational Standard of Care Participants in this group did not receive any treatment during the study.

Participant Flow:   Overall Study
    Part A - Cvac   Part A - Placebo   Part B - Cvac   Part B - Observational Standard of Care
STARTED   40   36   8   7 
Received Treatment   20   20   3   4 
COMPLETED   11   10   0   0 
NOT COMPLETED   29   26   8   7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo.

Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).


Reporting Groups
  Description
Part A - Cvac Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
Part A - Placebo Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
Part B - Cvac Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
Part B - Observational Standard of Care Participants in this group did not receive any treatment during the study.
Total Total of all reporting groups

Baseline Measures
   Part A - Cvac   Part A - Placebo   Part B - Cvac   Part B - Observational Standard of Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   3   4   47 
Age, Customized 
[Units: Participants]
         
45-65 years of age   20   20   3   4   47 
Gender 
[Units: Participants]
Count of Participants
         
Female      20 100.0%      20 100.0%      3 100.0%      4 100.0%      47 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Part A - Overall Survival   [ Time Frame: Baseline to the end of the study (up to 3 years, 2 months) ]

2.  Secondary:   Part A - Time to Next Treatment   [ Time Frame: Baseline to the end of the study (up to 3 years, 2 months) ]

3.  Secondary:   Part A - Progression-free Survival   [ Time Frame: Baseline to the end of the study (up to 3 years, 2 months) ]

4.  Secondary:   Part B - Overall Survival   [ Time Frame: Baseline to the end of the study (up to 3 years, 2 months) ]

5.  Secondary:   Part B - Time to Next Treatment   [ Time Frame: Baseline to the end of the study (up to 3 years, 2 months) ]

6.  Secondary:   Part B - Progression-free Survival   [ Time Frame: Baseline to the end of the study (up to 3 years, 2 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Marc Voigt
Organization: Prima BioMed, Ltd.
phone: 49 173 6771602
e-mail: marc.voigt@primabiomed.com.au



Responsible Party: Prima BioMed Ltd
ClinicalTrials.gov Identifier: NCT01521143     History of Changes
Other Study ID Numbers: CAN-004
Study First Received: January 17, 2012
Results First Received: November 16, 2016
Last Updated: December 9, 2016