We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study (CAN-003X)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01617629
First Posted: June 12, 2012
Last Update Posted: December 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prima BioMed Ltd
Results First Submitted: November 10, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Epithelial Ovarian Cancer
Intervention: Biological: MUC1 Dendritic Cell Vaccine (Cvac)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants with ovarian cancer who participated in CAN-003 [NCT01068509] and had disease progression were enrolled in CAN-003x in Australia and the United States from December 2011 to April 2014.

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
Cvac Treatment Group

Participants received Epithelial Mucin Surface Antigen 1 (MUC1) Dendritic Cell Vaccine (Cvac) treatment.

MUC1 Dendritic Cell Vaccine (Cvac): The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac).

Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks).


Participant Flow:   Overall Study
    Cvac Treatment Group
STARTED   9 
COMPLETED   3 
NOT COMPLETED   6 
Death                2 
Investigator's Clinical Judgement                1 
Reason Not Specified                1 
Participant Withdrew Consent                2 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Safety population included all participants who enrolled in the study.

Reporting Groups
  Description
Cvac Treatment Group

Participants received MUC1 Dendritic Cell Vaccine (Cvac) treatment.

MUC1 Dendritic Cell Vaccine (Cvac): The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac).

Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks).


Baseline Measures
   Cvac Treatment Group 
Overall Participants Analyzed 
[Units: Participants]
 9 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.3  (7.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      9 100.0% 
Male      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
White   9 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)   [ Time Frame: First dose of study vaccine to 30 days past last dose (Approximately 1 Year) ]

2.  Other Pre-specified:   Overall Survival   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

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: PrimaBioMed, Ltd.
phone: 49 173 6771602
e-mail: marc.voigt@primabiomed.com.au


Publications:
Desai J, Mitchell P, Loveland B, et al. A phase I trial of dendritic cells pulsed with MUC1 peptide in patients with solid tumours. Proc ASCO 2002; 21:15b (A1868).
Ozols RF, Rubin SC, Thomas G, et al. Epithelial ovarian cancer. In: Hoskins WJ, Perez CA, Young RC, eds. Principles and Practice of Gynecologic Oncology, 4th ed. Philadelphia: Lippincott Williams & Wilkins. 2005:919-922.


Responsible Party: Prima BioMed Ltd
ClinicalTrials.gov Identifier: NCT01617629     History of Changes
Other Study ID Numbers: CAN-003X
First Submitted: June 8, 2012
First Posted: June 12, 2012
Results First Submitted: November 10, 2017
Results First Posted: December 8, 2017
Last Update Posted: December 8, 2017