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

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. Identifier: NCT01617629
Recruitment Status : Completed
First Posted : June 12, 2012
Results First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Information provided by (Responsible Party):
Prima BioMed Ltd

Tracking Information
First Submitted Date  ICMJE June 8, 2012
First Posted Date  ICMJE June 12, 2012
Results First Submitted Date  ICMJE November 10, 2017
Results First Posted Date  ICMJE December 8, 2017
Last Update Posted Date December 8, 2017
Study Start Date  ICMJE December 2011
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2017)
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) ]
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the drug. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2012)
To evaluate the safety of Cvac administration in this population [ Time Frame: up to 2 years ]
Change History Complete list of historical versions of study NCT01617629 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: November 10, 2017)
Overall Survival [ Time Frame: 2 years ]
Overall survival was defined as the time from randomization until death from any cause.
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study
Official Title  ICMJE An Open-Label Safety Trial of Cvac (Autologous Dendritic Cells Pulsed With Recombinant Human Fusion Protein Coupled to Oxidized Polymannose) for Epithelial Ovarian Cancer Patients Who Have Progressed During the CAN-003 Study
Brief Summary The purpose of this trial is to assess the safety profile of Cvac for epithelial ovarian cancer patients who were enrolled in the Cvac clinical trial CAN-003 and are no longer eligible for study participation due to disease progression.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epithelial Ovarian Cancer
Intervention  ICMJE Biological: 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).

Study Arms  ICMJE Experimental: Cvac Treatment Group
Participants received Epithelial Mucin Surface Antigen 1 (MUC1) Dendritic Cell Vaccine (Cvac) treatment.
Intervention: Biological: MUC1 Dendritic Cell Vaccine (Cvac)
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2012)
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2012)
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female patients ≥ 18 years old with histologically confirmed Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube cancer who were enrolled in CAN-003
  • Able and willing to undergo mononuclear cell (MNC) collection (if required for patients who do not have available Cvac doses)
  • Were enrolled in CAN-003 and met protocol criteria for progressive disease
  • Wish to remain in the study and, in the investigator's judgment, the potential benefit of Cvac treatment outweighs the risk
  • Must be non-pregnant and, if of childbearing potential, must use adequate birth control (hormonal or barrier method of birth control or abstinence) for the duration of the study and for 3 months after study completion
  • Able to provide written informed consent
  • White blood cell count (WBC) ≥ 3.0 K/μL, absolute neutrophil count ≥ 1.5 K/μL, hemoglobin ≥ 9.0 g/dL, and platelets ≥100,000/mm^3

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Other medical conditions which preclude study participation, in the opinion of the investigator
  • Receiving treatment with any other investigational product
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01617629
Other Study ID Numbers  ICMJE CAN-003X
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prima BioMed Ltd
Study Sponsor  ICMJE Prima BioMed Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Heidy Gray, MD University of Washington
Principal Investigator: James Mason, MD Scripps Cancer Center
Principal Investigator: Peter Eisenberg, MD Marin Cancer Care
Principal Investigator: Giuseppe Del Priore, MD Indiana University School of Medicine
Principal Investigator: Fernando Recio, MD Collaborative Research Group
Principal Investigator: Jeffery Goh, MBBS, FRACP Greenslopes Private Hospital
PRS Account Prima BioMed Ltd
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP