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41513

Description

Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Keywords

Versions (2)
  1. 9/17/20 9/17/20 -
  2. 10/30/20 10/30/20 -
Copyright Holder

GlaxoSmithKline

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October 30, 2020

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Creative Commons BY 4.0
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    Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162

    English

    Best overall response assessment; New tumor biopsy/ sample (Report Final and Annex Report 2 Final)

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Patient Number
    Description

    Patient Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Best overall response assessment
    Description

    Best overall response assessment

    Alias
    UMLS CUI-1
    C2986560
    UMLS CUI-2
    C1516048
    What is the best overall response assessed during the study?
    Description

    * For patients with all target lesions < 20 mm only (< 10 mm with spiral CT-scan) ** NE = Non Evaluable

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2986560
    UMLS CUI [1,2]
    C1516048
    If CR, was there a suspicion of residual disease?
    Description

    If CR, was there a suspicion of residual disease?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0677874
    UMLS CUI [2]
    C0543478
    If suspicion of residual disease, was CR status been confirmed by cytology?
    Description

    If suspicion of residual disease, was CR status been confirmed by cytology?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0543478
    UMLS CUI [1,2]
    C0242114
    UMLS CUI [2]
    C0677874
    UMLS CUI [3,1]
    C0750484
    UMLS CUI [3,2]
    C0010819
    Date of first documented [ CR ], [ PR ] response
    Description

    Date of first documented [ CR ], [ PR ] response

    Data type

    date

    Alias
    UMLS CUI [1]
    C0677874
    UMLS CUI [2]
    C1521726
    UMLS CUI [3,1]
    C0011008
    UMLS CUI [3,2]
    C0920316
    UMLS CUI [3,3]
    C0205435
    Date of best response confirmation [ CR ], [ PR ]:
    Description

    Date of best response confirmation [ CR ], [ PR ]:

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    UMLS CUI [2,1]
    C2986560
    UMLS CUI [2,2]
    C0750484
    UMLS CUI [3]
    C0677874
    UMLS CUI [4]
    C1521726
    If [ SD ], [SD/PR*]: Date of last documented stable disease:
    Description

    If [ SD ], [SD/PR*]: Date of last documented stable disease:

    Data type

    date

    Alias
    UMLS CUI [1]
    C0677946
    UMLS CUI [2]
    C1521726
    UMLS CUI [3,1]
    C1517741
    UMLS CUI [3,2]
    C1301725
    UMLS CUI [3,3]
    C0011008
    Has the patient developed a recurrence / Progressive disease?
    Description

    Has the patient developed a recurrence / Progressive disease?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1335499
    UMLS CUI [2]
    C0277556
    Recurrence / Progressive disease date
    Description

    Recurrence / Progressive disease date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1335499
    UMLS CUI [2]
    C0277556
    UMLS CUI [3]
    C0011008
    Has the recurrence / progressive disease been histologically or cytologically confirmed?
    Description

    Has the recurrence / progressive disease been histologically or cytologically confirmed?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1335499
    UMLS CUI [2]
    C0679254
    UMLS CUI [3,1]
    C0750484
    UMLS CUI [3,2]
    C0205462
    UMLS CUI [4,1]
    C0750484
    UMLS CUI [4,2]
    C0205471
    Please specify the method used to confirm the recurrence / progressive disease:
    Description

    (tick only one box)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0277556
    UMLS CUI [1,2]
    C0750484
    UMLS CUI [2,1]
    C1335499
    UMLS CUI [2,2]
    C0750484
    UMLS CUI [3,1]
    C2348235
    UMLS CUI [3,2]
    C0871511
    Has the informed consent been signed for MAGE-A3 expression testing and gene profiling of newly resected tumors in case of disease progression
    Description

    Has the informed consent been signed for MAGE-A3 expression testing and gene profiling of newly resected tumors in case of disease progression

    Data type

    text

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2,1]
    C0962473
    UMLS CUI [2,2]
    C0017262
    UMLS CUI [2,3]
    C0022885
    UMLS CUI [3,1]
    C0728940
    UMLS CUI [3,2]
    C0205314
    UMLS CUI [3,3]
    C0027651
    UMLS CUI [4]
    C0242656
    Informed Consent Date
    Description

    Informed Consent Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985782
    New tumor biopsy/ sample
    Description

    New tumor biopsy/ sample

    Alias
    UMLS CUI-1
    C0475358
    UMLS CUI-2
    C0005558
    UMLS CUI-3
    C0205314
    Has a new fresh biopsy been collected?
    Description

    Has a new fresh biopsy been collected?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005558
    UMLS CUI [1,2]
    C2827486
    UMLS CUI [1,3]
    C1516698
    Date of biopsy (fresh biopsy)
    Description

    Date of biopsy (fresh biopsy)

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005558
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [2,1]
    C0005558
    UMLS CUI [2,2]
    C2827486
    Requisition number (fresh biopsy)
    Description

    Requisition number (fresh biopsy)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1514821
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [2,1]
    C0005558
    UMLS CUI [2,2]
    C2827486
    Tumor biopsy type (fresh biopsy)
    Description

    Tumor biopsy type (fresh biopsy)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0475358
    UMLS CUI [1,2]
    C0005558
    UMLS CUI [1,3]
    C0332307
    UMLS CUI [2,1]
    C0005558
    UMLS CUI [2,2]
    C2827486
    If other tumor biopsy type, specify (fresh biopsy)
    Description

    If other tumor biopsy type, specify (fresh biopsy)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0475358
    UMLS CUI [1,2]
    C0005558
    UMLS CUI [1,3]
    C0332307
    UMLS CUI [2]
    C0205394
    UMLS CUI [3]
    C2348235
    UMLS CUI [4,1]
    C0005558
    UMLS CUI [4,2]
    C2827486
    What is the status of the lesion resected? (fresh biopsy)
    Description

    What is the status of the lesion resected? (fresh biopsy)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0728940
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [2]
    C0449438
    UMLS CUI [3,1]
    C0005558
    UMLS CUI [3,2]
    C2827486
    Has a new Formalin fixed Paraffin embedded (FFPE) been collected?
    Description

    Has a new Formalin fixed Paraffin embedded (FFPE) been collected?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0475358
    UMLS CUI [1,2]
    C2711483
    UMLS CUI [2]
    C1516698
    UMLS CUI [3]
    C0205314
    Date of biopsy (FFPE)
    Description

    Date of biopsy (FFPE)

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005558
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [2]
    C2711483
    Requisition number (FFPE):
    Description

    Requisition number (FFPE):

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1514821
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [2]
    C2711483
    Tumor block or tumor slides? (FFPE)
    Description

    Tumor block or tumor slides? (FFPE)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0475358
    UMLS CUI [1,2]
    C1265611
    UMLS CUI [1,3]
    C2317347
    UMLS CUI [2,1]
    C0027651
    UMLS CUI [2,2]
    C0026017
    UMLS CUI [3]
    C2711483
    Number of tumor slides sent (FFPE)
    Description

    Number of tumor slides sent (FFPE)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0027651
    UMLS CUI [1,2]
    C0026017
    UMLS CUI [1,3]
    C0237753
    UMLS CUI [2]
    C2711483
    Does the FFPE come from the same lesion as the fresh biopsy?
    Description

    Does the FFPE come from the same lesion as the fresh biopsy?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2711483
    UMLS CUI [2,1]
    C0677862
    UMLS CUI [2,2]
    C2827486
    UMLS CUI [3,1]
    C0221198
    UMLS CUI [3,2]
    C0445247
    If the FFPE does not come from the same lesion as the fresh biopsy, enter FFPE sample type
    Description

    If the FFPE does not come from the same lesion as the fresh biopsy, enter FFPE sample type

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2711483
    UMLS CUI [2,1]
    C0677862
    UMLS CUI [2,2]
    C2827486
    UMLS CUI [3,1]
    C0221198
    UMLS CUI [3,2]
    C0445247
    UMLS CUI [4]
    C2347029
    Other FFPE sample type
    Description

    Other FFPE sample type

    Data type

    text

    Alias
    UMLS CUI [1]
    C2711483
    UMLS CUI [2]
    C2347029
    UMLS CUI [3]
    C0205394
    UMLS CUI [4]
    C2348235
    What is the status of the lesion resected? (FFPE)
    Description

    What is the status of the lesion resected? (FFPE)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0728940
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [2]
    C0449438
    UMLS CUI [3]
    C2711483
    Did the patient receive any anti-cancer treatment before biopsy (other than study treatment)?
    Description

    Yes → Please complete Anti-cancer therapy section

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0920425
    UMLS CUI [2,1]
    C0005558
    UMLS CUI [2,2]
    C0332152
    UMLS CUI [3,1]
    C0949266
    UMLS CUI [3,2]
    C0205394
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    Similar models

    Best overall response assessment; New tumor biopsy/ sample (Report Final and Annex Report 2 Final)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Patient Number
    Item
    Patient Number
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Best overall response assessment
    C2986560 (UMLS CUI-1)
    C1516048 (UMLS CUI-2)
    Item
    What is the best overall response assessed during the study?
    integer
    C2986560 (UMLS CUI [1,1])
    C1516048 (UMLS CUI [1,2])
    What is the best overall response assessed during the study?
    Code List
    What is the best overall response assessed during the study?
    CL Item
    CR (1)
    CL Item
    PR (2)
    CL Item
    SD (3)
    CL Item
    SD / PR (4)
    CL Item
    PD (5)
    CL Item
    NE** (6)
    If CR, was there a suspicion of residual disease?
    Item
    If CR, was there a suspicion of residual disease?
    boolean
    C0677874 (UMLS CUI [1])
    C0543478 (UMLS CUI [2])
    If suspicion of residual disease, was CR status been confirmed by cytology?
    Item
    If suspicion of residual disease, was CR status been confirmed by cytology?
    boolean
    C0543478 (UMLS CUI [1,1])
    C0242114 (UMLS CUI [1,2])
    C0677874 (UMLS CUI [2])
    C0750484 (UMLS CUI [3,1])
    C0010819 (UMLS CUI [3,2])
    Date of first documented [ CR ], [ PR ] response
    Item
    Date of first documented [ CR ], [ PR ] response
    date
    C0677874 (UMLS CUI [1])
    C1521726 (UMLS CUI [2])
    C0011008 (UMLS CUI [3,1])
    C0920316 (UMLS CUI [3,2])
    C0205435 (UMLS CUI [3,3])
    Date of best response confirmation [ CR ], [ PR ]:
    Item
    Date of best response confirmation [ CR ], [ PR ]:
    date
    C0011008 (UMLS CUI [1])
    C2986560 (UMLS CUI [2,1])
    C0750484 (UMLS CUI [2,2])
    C0677874 (UMLS CUI [3])
    C1521726 (UMLS CUI [4])
    If [ SD ], [SD/PR*]: Date of last documented stable disease:
    Item
    If [ SD ], [SD/PR*]: Date of last documented stable disease:
    date
    C0677946 (UMLS CUI [1])
    C1521726 (UMLS CUI [2])
    C1517741 (UMLS CUI [3,1])
    C1301725 (UMLS CUI [3,2])
    C0011008 (UMLS CUI [3,3])
    Has the patient developed a recurrence / Progressive disease?
    Item
    Has the patient developed a recurrence / Progressive disease?
    boolean
    C1335499 (UMLS CUI [1])
    C0277556 (UMLS CUI [2])
    Recurrence / Progressive disease date
    Item
    Recurrence / Progressive disease date
    date
    C1335499 (UMLS CUI [1])
    C0277556 (UMLS CUI [2])
    C0011008 (UMLS CUI [3])
    Has the recurrence / progressive disease been histologically or cytologically confirmed?
    Item
    Has the recurrence / progressive disease been histologically or cytologically confirmed?
    boolean
    C1335499 (UMLS CUI [1])
    C0679254 (UMLS CUI [2])
    C0750484 (UMLS CUI [3,1])
    C0205462 (UMLS CUI [3,2])
    C0750484 (UMLS CUI [4,1])
    C0205471 (UMLS CUI [4,2])
    Item
    Please specify the method used to confirm the recurrence / progressive disease:
    integer
    C0277556 (UMLS CUI [1,1])
    C0750484 (UMLS CUI [1,2])
    C1335499 (UMLS CUI [2,1])
    C0750484 (UMLS CUI [2,2])
    C2348235 (UMLS CUI [3,1])
    C0871511 (UMLS CUI [3,2])
    Please specify the method used to confirm the recurrence / progressive disease:
    Code List
    Please specify the method used to confirm the recurrence / progressive disease:
    CL Item
    Cytology  (1)
    CL Item
    Histology → Please complete ICF section for MAGE-A3 Expression testing and for gene profiling of newly resected tumors in case of disease progression.  (2)
    CL Item
    Cytology and histology → Please complete ICF section for MAGE-A3 Expression testing and for gene profiling of newly resected tumors in case of disease progression. (3)
    Item
    Has the informed consent been signed for MAGE-A3 expression testing and gene profiling of newly resected tumors in case of disease progression
    text
    C0021430 (UMLS CUI [1])
    C0962473 (UMLS CUI [2,1])
    C0017262 (UMLS CUI [2,2])
    C0022885 (UMLS CUI [2,3])
    C0728940 (UMLS CUI [3,1])
    C0205314 (UMLS CUI [3,2])
    C0027651 (UMLS CUI [3,3])
    C0242656 (UMLS CUI [4])
    Has the informed consent been signed for MAGE-A3 expression testing and gene profiling of newly resected tumors in case of disease progression
    Code List
    Has the informed consent been signed for MAGE-A3 expression testing and gene profiling of newly resected tumors in case of disease progression
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    NA (NA)
    Informed Consent Date
    Item
    Informed Consent Date
    date
    C2985782 (UMLS CUI [1])
    Item Group
    New tumor biopsy/ sample
    C0475358 (UMLS CUI-1)
    C0005558 (UMLS CUI-2)
    C0205314 (UMLS CUI-3)
    Has a new fresh biopsy been collected?
    Item
    Has a new fresh biopsy been collected?
    boolean
    C0005558 (UMLS CUI [1,1])
    C2827486 (UMLS CUI [1,2])
    C1516698 (UMLS CUI [1,3])
    Date of biopsy (fresh biopsy)
    Item
    Date of biopsy (fresh biopsy)
    date
    C0005558 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0005558 (UMLS CUI [2,1])
    C2827486 (UMLS CUI [2,2])
    Requisition number (fresh biopsy)
    Item
    Requisition number (fresh biopsy)
    text
    C1514821 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C0005558 (UMLS CUI [2,1])
    C2827486 (UMLS CUI [2,2])
    Item
    Tumor biopsy type (fresh biopsy)
    integer
    C0475358 (UMLS CUI [1,1])
    C0005558 (UMLS CUI [1,2])
    C0332307 (UMLS CUI [1,3])
    C0005558 (UMLS CUI [2,1])
    C2827486 (UMLS CUI [2,2])
    Tumor biopsy type:
    Code List
    Tumor biopsy type (fresh biopsy)
    CL Item
    Skin (1)
    CL Item
    Subcutaneous (2)
    CL Item
    Lymphnode (3)
    CL Item
    Other, specify (4)
    If other tumor biopsy type, specify (fresh biopsy)
    Item
    If other tumor biopsy type, specify (fresh biopsy)
    text
    C0475358 (UMLS CUI [1,1])
    C0005558 (UMLS CUI [1,2])
    C0332307 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [2])
    C2348235 (UMLS CUI [3])
    C0005558 (UMLS CUI [4,1])
    C2827486 (UMLS CUI [4,2])
    Item
    What is the status of the lesion resected? (fresh biopsy)
    integer
    C0728940 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C0449438 (UMLS CUI [2])
    C0005558 (UMLS CUI [3,1])
    C2827486 (UMLS CUI [3,2])
    What is the status of the lesion resected?
    Code List
    What is the status of the lesion resected? (fresh biopsy)
    CL Item
    New lesion (1)
    CL Item
    Progressive target lesion (2)
    CL Item
    Progressive non-target lesion (3)
    Has a new Formalin fixed Paraffin embedded (FFPE) been collected?
    Item
    Has a new Formalin fixed Paraffin embedded (FFPE) been collected?
    boolean
    C0475358 (UMLS CUI [1,1])
    C2711483 (UMLS CUI [1,2])
    C1516698 (UMLS CUI [2])
    C0205314 (UMLS CUI [3])
    Date of biopsy (FFPE)
    Item
    Date of biopsy (FFPE)
    date
    C0005558 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C2711483 (UMLS CUI [2])
    Requisition number (FFPE):
    Item
    Requisition number (FFPE):
    text
    C1514821 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C2711483 (UMLS CUI [2])
    Item
    Tumor block or tumor slides? (FFPE)
    integer
    C0475358 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C2317347 (UMLS CUI [1,3])
    C0027651 (UMLS CUI [2,1])
    C0026017 (UMLS CUI [2,2])
    C2711483 (UMLS CUI [3])
    Tumor block or tumor slides? (FFPE)
    Code List
    Tumor block or tumor slides? (FFPE)
    CL Item
    Tumor block  (1)
    CL Item
    Tumor slides (2)
    Number of tumor slides sent (FFPE)
    Item
    Number of tumor slides sent (FFPE)
    integer
    C0027651 (UMLS CUI [1,1])
    C0026017 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    C2711483 (UMLS CUI [2])
    Does the FFPE come from the same lesion as the fresh biopsy?
    Item
    Does the FFPE come from the same lesion as the fresh biopsy?
    boolean
    C2711483 (UMLS CUI [1])
    C0677862 (UMLS CUI [2,1])
    C2827486 (UMLS CUI [2,2])
    C0221198 (UMLS CUI [3,1])
    C0445247 (UMLS CUI [3,2])
    Item
    If the FFPE does not come from the same lesion as the fresh biopsy, enter FFPE sample type
    integer
    C2711483 (UMLS CUI [1])
    C0677862 (UMLS CUI [2,1])
    C2827486 (UMLS CUI [2,2])
    C0221198 (UMLS CUI [3,1])
    C0445247 (UMLS CUI [3,2])
    C2347029 (UMLS CUI [4])
    If the FFPE does not come from the same lesion as the fresh biopsy, enter FFPE sample type
    Code List
    If the FFPE does not come from the same lesion as the fresh biopsy, enter FFPE sample type
    CL Item
    Skin  (1)
    CL Item
    Subcutaneous  (2)
    CL Item
    Lymphnode (3)
    CL Item
    Other, please specify (4)
    Other FFPE sample type
    Item
    Other FFPE sample type
    text
    C2711483 (UMLS CUI [1])
    C2347029 (UMLS CUI [2])
    C0205394 (UMLS CUI [3])
    C2348235 (UMLS CUI [4])
    Item
    What is the status of the lesion resected? (FFPE)
    integer
    C0728940 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C0449438 (UMLS CUI [2])
    C2711483 (UMLS CUI [3])
    What is the status of the lesion resected? (FFPE)
    Code List
    What is the status of the lesion resected? (FFPE)
    CL Item
    New lesion  (1)
    CL Item
    Progressive target lesion  (2)
    CL Item
    Progressive non-target lesion (3)
    Did the patient receive any anti-cancer treatment before biopsy (other than study treatment)?
    Item
    Did the patient receive any anti-cancer treatment before biopsy (other than study treatment)?
    boolean
    C0920425 (UMLS CUI [1])
    C0005558 (UMLS CUI [2,1])
    C0332152 (UMLS CUI [2,2])
    C0949266 (UMLS CUI [3,1])
    C0205394 (UMLS CUI [3,2])
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