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

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

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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
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
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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

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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.
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

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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) ]

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2. Other Pre-specified:

Overall Survival [ Time Frame: 2 years ]

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  Serious Adverse Events

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  Other Adverse Events

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  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
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  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: 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. 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. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: For study centers in Australia, no publication of the study results may be made until publication of the results of the study from all centers or until 2 years after study completion, whichever is sooner. For study centers in the USA, no submission for publication or public disclosure of the results by will be made until the results from all centers have been received and analyzed by the sponsor, or the multi-center study has been terminated or abandoned at all centers.

Results Point of Contact:  

Name/Title: Marc Voigt
Organization: PrimaBioMed, Ltd.
phone: 49 173 6771602
e-mail: marc.voigt@primabiomed.com.au

Publications:

Apostolopoulos V, McKenzie IF. Cellular mucins: targets for immunotherapy. Crit Rev Immunol. 1994;14(3-4):293-309. Review.

Apostolopoulos V, McKenzie IF, Pietersz GA. Breast cancer immunotherapy: current status and future prospects. Immunol Cell Biol. 1996 Oct;74(5):457-64. Review.

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).

Apostolopoulos V, Karanikas V, Haurum JS, McKenzie IF. Induction of HLA-A2-restricted CTLs to the mucin 1 human breast cancer antigen. J Immunol. 1997 Dec 1;159(11):5211-8.

Grossi M, Quinn MA, Thursfield VJ, Francis PA, Rome RM, Planner RS, Giles GG. Ovarian cancer: patterns of care in Victoria during 1993-1995. Med J Aust. 2002 Jul 1;177(1):11-6.

Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20.

Liu PY, Alberts DS, Monk BJ, Brady M, Moon J, Markman M. An early signal of CA-125 progression for ovarian cancer patients receiving maintenance treatment after complete clinical response to primary therapy. J Clin Oncol. 2007 Aug 20;25(24):3615-20.

Meyer T, Rustin GJ. Role of tumour markers in monitoring epithelial ovarian cancer. Br J Cancer. 2000 May;82(9):1535-8. Review.

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.

Rustin GJ, Nelstrop AE, Bentzen SM, Bond SJ, McClean P. Selection of active drugs for ovarian cancer based on CA-125 and standard response rates in phase II trials. J Clin Oncol. 2000 Apr;18(8):1733-9.

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