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Study to Assess Safety and Immune Response of Stage IIB-IV Resected Melanoma After Treatment With MAGE-A3 ASCI (Mel55)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Craig L Slingluff, Jr, University of Virginia
ClinicalTrials.gov Identifier:
NCT01425749
First received: July 19, 2011
Last updated: March 2, 2016
Last verified: March 2016
Results First Received: December 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Melanoma
Intervention: Biological: recMAGE-A3 + AS15 ASCI

  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
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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
Arm A: Intramuscular Injections

Intramuscular injections.

recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.

Arm B: Intradermal/Subcutaneous Injections

Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.

recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.


Participant Flow:   Overall Study
    Arm A: Intramuscular Injections     Arm B: Intradermal/Subcutaneous Injections  
STARTED     13     12  
COMPLETED     13     11  
NOT COMPLETED     0     1  
progression of melanoma                 0                 1  



  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.
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Reporting Groups
  Description
Arm A

Intramuscular injections.

recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.

Arm B

Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.

recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.

Total Total of all reporting groups

Baseline Measures
    Arm A     Arm B     Total  
Number of Participants  
[units: participants]
  13     12     25  
Age  
[units: years]
Mean (Full Range)
  56  
  (39 to 82)  
  54  
  (40 to 69)  
  55  
  (39 to 82)  
Gender  
[units: participants]
     
Female     8     5     13  
Male     5     7     12  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     13     12     25  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     1     1  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     13     11     24  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     13     12     25  
Stage of Melanoma [1]
[units: participants]
     
Stage IIIB     3     5     8  
Stage IIIC     5     3     8  
Stage IV     5     4     9  
[1] AJCC staging, version 7



  Outcome Measures
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1.  Primary:   Number of Participants With Treatment-related Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: Over 6 months ]

2.  Primary:   Enumeration of CD4 and CD8 T Cell Responses to MAGE-A3 Epitopes in the Injection Site-draining Lymph Node (Sentinel Immunized Node, SIN) as a Measure of Immunogenicity.   [ Time Frame: One week after 3 doses of study drug, on day 22. ]

3.  Secondary:   Enumeration of CD4+ and CD8+ T Cells Reactive to MAGE-A3 Epitopes in Peripheral Blood as a Measure of Immunogenicity.   [ Time Frame: Over 6 months ]

4.  Secondary:   Identification of Antibody Responses to MAGE-A3 After MAGE-A3 ASCI Administration as a Measure of Immunogenicity.   [ Time Frame: Over 6 months, typically weeks 1, 7, 13, 26 ]

5.  Secondary:   Characterization of the Maturation and Activation of Dendritic Cell (DC) Populations in the Sentinel Immunized Node (SIN) After Treatment With MAGE-A3 ASCI.   [ Time Frame: Over 3 weeks ]

6.  Secondary:   A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).   [ Time Frame: Over 6 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
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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 NOT 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.


Results Point of Contact:  
Name/Title: Craig L Slingluff Jr
Organization: University of Virginia
phone: 434-924-1730
e-mail: cls8h@virginia.edu


Publications of Results:

Responsible Party: Craig L Slingluff, Jr, University of Virginia
ClinicalTrials.gov Identifier: NCT01425749     History of Changes
Other Study ID Numbers: CSlingluff
Study First Received: July 19, 2011
Results First Received: December 13, 2015
Last Updated: March 2, 2016
Health Authority: United States: Food and Drug Administration