0 Ratings
ID

42779

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. 8/25/20 8/25/20 -
  2. 9/17/21 9/17/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 17, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162

    English

    Eligibility Check

    1 forms  
    1. StudyEvent: ODM
      1. Eligibility Check
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Patient Number
    Description

    Patient Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Eligibility Check
    Description

    Eligibility Check

    Alias
    UMLS CUI-1
    C0013893
    Did the patient meet all the entry criteria?
    Description

    Did the patient meet all the entry criteria?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1516637
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    Male or female patients with histologically proven metastatic cutaneous melanoma that is measurable
    Description

    Male or female patients with histologically proven metastatic cutaneous melanoma that is measurable

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0205462
    UMLS CUI [2]
    C0456369
    UMLS CUI [3,1]
    C0151779
    UMLS CUI [3,2]
    C0027627
    UMLS CUI [4]
    C1513041
    Patients with regional or distant cutaneous, subcutaneous or lymph-node metastasis can be included in the study, provided the disease is not amenable to curative treatment with surgery. In terms of the AJCC 2002 classification [AJCC, 2002], this includes patients with unresectable stage III melanoma including in-transit metastases or patient with stage IV M1a melanoma.
    Description

    Regional lymph node metastasis present; Cutaneous | Regional lymph node metastasis present; subcutaneous | Distant metastasis present; Cutaneous | Distant metastasis present; subcutaneous | Disease; Operative Surgical Procedures; Cure (remedy) | AJCC tumor staging | Unresectable; Stage level 3; melanoma | In-Transit Metastasis | melanoma; Stage level 4; Metastasis stage M1a

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1275854
    UMLS CUI [1,2]
    C0221912
    UMLS CUI [2,1]
    C1275854
    UMLS CUI [2,2]
    C0443315
    UMLS CUI [3,1]
    C1275402
    UMLS CUI [3,2]
    C0221912
    UMLS CUI [4,1]
    C1275402
    UMLS CUI [4,2]
    C0443315
    UMLS CUI [5,1]
    C0012634
    UMLS CUI [5,2]
    C0543467
    UMLS CUI [5,3]
    C1880198
    UMLS CUI [6]
    C0441915
    UMLS CUI [7,1]
    C1519810
    UMLS CUI [7,2]
    C0441771
    UMLS CUI [7,3]
    C0025202
    UMLS CUI [8]
    C2985554
    UMLS CUI [9,1]
    C0025202
    UMLS CUI [9,2]
    C0441772
    UMLS CUI [9,3]
    C0445036
    Written informed consent obtained from the patient prior to performance of any study specific procedure.
    Description

    Written informed consent obtained from the patient prior to performance of any study specific procedure.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Patient is ≥ 18 years at the time of signature of the informed consent form.
    Description

    Patient is ≥ 18 years at the time of signature of the informed consent form.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C0021430
    The patient’s tumor expresses MAGE-A3, as determined by RT-PCR analysis on a fresh tumor tissue sample obtained during the screening phase.
    Description

    The patient’s tumor expresses MAGE-A3, as determined by RT-PCR analysis on a fresh tumor tissue sample obtained during the screening phase.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0962473
    UMLS CUI [1,2]
    C0017262
    UMLS CUI [2]
    C0599161
    UMLS CUI [3,1]
    C1292533
    UMLS CUI [3,2]
    C2827486
    UMLS CUI [4]
    C0220908
    Fresh tissue from the same lesion must be available for MAGE-A3 expression testing and for the testing of the predictive gene signature
    Description

    Fresh tissue from the same lesion must be available for MAGE-A3 expression testing and for the testing of the predictive gene signature

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1292533
    UMLS CUI [1,2]
    C2827486
    UMLS CUI [2,1]
    C0221198
    UMLS CUI [2,2]
    C0445247
    UMLS CUI [3,1]
    C0962473
    UMLS CUI [3,2]
    C0017262
    UMLS CUI [4,1]
    C1708225
    UMLS CUI [4,2]
    C0681890
    Formalin-fixed paraffin-embedded (FFPE) tissue must be available for complementary MAGE-A3 and gene signature testing.This FFPE tissue should preferably come from the same (reference) lesion as the fresh tissue used for MAGE-A3 and gene signature testing but may be taken from a second lesion during the screening phase if the reference lesion does not provide sufficient tissue.
    Description

    Formalin-fixed paraffin-embedded tissue specimen; Availability of | MAGEA3 protein, human; Laboratory Procedures | Gene Signature; Laboratory Procedures | C0221198 Lesion; Same | Tissue specimen; Fresh Specimen | Lesion; second (number) | Screening procedure

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2711483
    UMLS CUI [1,2]
    C0470187
    UMLS CUI [2,1]
    C0962473
    UMLS CUI [2,2]
    C0022885
    UMLS CUI [3,1]
    C1708225
    UMLS CUI [3,2]
    C0022885
    UMLS CUI [4,1]
    C0221198
    UMLS CUI [4,2]
    C0445247
    UMLS CUI [5,1]
    C1292533
    UMLS CUI [5,2]
    C2827486
    UMLS CUI [6,1]
    C0221198
    UMLS CUI [6,2]
    C0205436
    UMLS CUI [7]
    C0220908
    Patient fully recovered from any previous intervention (i.e., biopsy).
    Description

    Patient fully recovered from any previous intervention (i.e., biopsy).

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2826210
    UMLS CUI [1,2]
    C1514463
    UMLS CUI [2]
    C0005558
    Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    Description

    Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria, and defined as: - Absolute neutrophil count ≥ 1.5 x 109/L - Platelet count ≥ 75 x 109/L - Serum creatinine ≤ 1.5 times the Upper Limit of Normal (ULN) - Total bilirubin ≤ 1.5 times the ULN - Lactate Dehydrogenase (LDH) LDH ≤ ULN - Alanine transaminase (ALAT) ≤ 2.5 times the ULN - Aspartate aminotransferase (ASAT) ≤ 2.5 times ULN
    Description

    Bone Marrow; Adequate | Renal function; Adequate | Liver function; Adequate | Laboratory; criteria; Standard (qualifier) | Absolute neutrophil count | Platelet Count measurement | Creatinine measurement, serum (procedure) | Bilirubin, total measurement | Lactate dehydrogenase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Upper Limit of Normal

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005953
    UMLS CUI [1,2]
    C0205411
    UMLS CUI [2,1]
    C0232804
    UMLS CUI [2,2]
    C0205411
    UMLS CUI [3,1]
    C0232741
    UMLS CUI [3,2]
    C0205411
    UMLS CUI [4,1]
    C0022877
    UMLS CUI [4,2]
    C0243161
    UMLS CUI [4,3]
    C1442989
    UMLS CUI [5]
    C0948762
    UMLS CUI [6]
    C0032181
    UMLS CUI [7]
    C0201976
    UMLS CUI [8]
    C0201913
    UMLS CUI [9]
    C0202113
    UMLS CUI [10]
    C0201836
    UMLS CUI [11]
    C0201899
    UMLS CUI [12]
    C1519815
    If the patient is female, she must be of non-childbearing potential, i.e., have a current tubal ligation, hysterectomy, ovariectomy or be post menopausal, or if she is of childbearing potential, she must practice adequate contraception for at least 30 days prior to registration in the trial, have a negative pregnancy test and continue such precautions during the entire study treatment period and for 2 months after completion of the injection series.
    Description

    When considering the enrolment of females of childbearing potential, please take note of the following definitions: • Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly (when applicable, as mentioned in the product label) for example abstinence, combined or progestogen oral contraceptives, injectable progestogen, implants of levonorgestrel, oestrogenic vaginal ring, percutaneous contraceptive patches or intrauterine device (IUD) or intrauterine system (IUS), vasectomy with documented azoospermia of the sole male partner or double barrier method (condom or occlusive cap plus spermicidal agent). For azoospermia, “documented” refers to the laboratory report of azoospermia required for documentation of acceptable vasectomy of the patient’s male partner. • Post-menopause: Menopause is the age associated with complete cessation of menstrual cycles, menses, and implies the loss of reproductive potential by ovarian failure. A practical definition accepts menopause after 1 year without menses with an appropriate clinical profile at the appropriate age e.g.,> 45 years.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3831118
    UMLS CUI [2]
    C0520483
    UMLS CUI [3]
    C0020699
    UMLS CUI [4]
    C0029936
    UMLS CUI [5]
    C0232970
    UMLS CUI [6]
    C0700589
    UMLS CUI [7]
    C0427780
    In the opinion of the investigator, the patient can and will comply with the protocol requirements.
    Description

    In the opinion of the investigator, the patient can and will comply with the protocol requirements.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0582783
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    Patients with unresectable stage IV M1b,c melanoma and patients with ocular and mucosal melanoma.
    Description

    Patients with unresectable stage IV M1b,c melanoma and patients with ocular and mucosal melanoma.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0025202
    UMLS CUI [1,2]
    C1519810
    UMLS CUI [2,1]
    C0441772
    UMLS CUI [2,2]
    C0441971
    UMLS CUI [3]
    C0558356
    UMLS CUI [4]
    C3898222
    The patient has at any time received any systemic anticancer treatment. • Prior systemic treatment with an immunomodulator (i.e., interferon or/and anti-CTL-A4 therapy) or loco-regional radiotherapy is permitted as prior adjuvant treatment provided that the last dose was administered at least 30 days before the registration into this trial; • Previous adjuvant treatment with a cancer vaccine containing a tumor antigen other than MAGE-A3 is allowed if the last administration took place at least 8 weeks before registration into the trial. • Prior isolated limb perfusion is permitted provided that the last dose was administered at least 30 days before registration into this trial.
    Description

    cancer treatment; Systemic | Interferon | Anti-CTLA-4 Monoclonal Antibody | Therapeutic radiology procedure; Local; regional | Adjuvant therapy; Before | Dosage; Last | Cancer Vaccines | Tumor Antigens | MAGEA3 protein, human | Isolated limb perfusion

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0920425
    UMLS CUI [1,2]
    C0205373
    UMLS CUI [2]
    C3652465
    UMLS CUI [3]
    C4289973
    UMLS CUI [4,1]
    C1522449
    UMLS CUI [4,2]
    C0205276
    UMLS CUI [4,3]
    C0205147
    UMLS CUI [5,1]
    C0677850
    UMLS CUI [5,2]
    C0332152
    UMLS CUI [6,1]
    C0178602
    UMLS CUI [6,2]
    C1517741
    UMLS CUI [7]
    C0376659
    UMLS CUI [8]
    C0041361
    UMLS CUI [9]
    C0962473
    UMLS CUI [10]
    C0396670
    The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, other immunotherapy, chemotherapy and immunomodulating agents.
    Description

    The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, other immunotherapy, chemotherapy and immunomodulating agents.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0920425
    UMLS CUI [1,2]
    C0205369
    UMLS CUI [2]
    C1522449
    UMLS CUI [3,1]
    C0021083
    UMLS CUI [3,2]
    C0205394
    UMLS CUI [4]
    C3665472
    UMLS CUI [5]
    C0021081
    The patient requires concomitant chronic treatment (more than 7 consecutive days) with systemic corticosteroids, or any other immunosuppressive agents. The use of prednisone, or equivalent, at a dose of ≤ 0.125 mg/kg/day (absolute maximum 10 mg/day) or topical steroids is permitted.
    Description

    Concomitant Therapy; chronic | systemic steroids | Immunosuppressive Agents; Other | prednisone; Medication dose | topical steroids

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1707479
    UMLS CUI [1,2]
    C0205191
    UMLS CUI [2]
    C2825233
    UMLS CUI [3,1]
    C0021081
    UMLS CUI [3,2]
    C0205394
    UMLS CUI [4,1]
    C0032952
    UMLS CUI [4,2]
    C3174092
    UMLS CUI [5]
    C2064827
    The patient has a history of autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
    Description

    The patient has a history of autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004364
    UMLS CUI [2]
    C0026769
    UMLS CUI [3]
    C0409974
    UMLS CUI [4]
    C0021390
    UMLS CUI [5]
    C0042900
    The patient has a family history of congenital or hereditary immunodeficiency.
    Description

    The patient has a family history of congenital or hereditary immunodeficiency.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0853602
    UMLS CUI [2,1]
    C0021051
    UMLS CUI [2,2]
    C0439660
    The patient is known to be positive for Human Immunodeficiency Virus (HIV).
    Description

    The patient is known to be positive for Human Immunodeficiency Virus (HIV).

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    History of allergic disease or reactions likely to be exacerbated by any component of ASCI treatment.
    Description

    History of allergic disease or reactions likely to be exacerbated by any component of the ASCI treatment.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0020517
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C4086268
    UMLS CUI [3]
    C1705248
    UMLS CUI [4,1]
    C0872278
    UMLS CUI [4,2]
    C0439859
    The patient has previous or concomitant malignancies at other sites, except • Effectively treated non-melanoma skin cancer or carcinoma in situ of the cervix • Effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
    Description

    Comorbidity; Malignant Neoplasms | Anatomic Site; Other | Skin carcinoma | Carcinoma in situ of uterine cervix

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0006826
    UMLS CUI [2,1]
    C1515974
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C0699893
    UMLS CUI [4]
    C0851140
    The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.
    Description

    The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004936
    UMLS CUI [2]
    C0085281
    UMLS CUI [3]
    C0021430
    The patient has an uncontrolled bleeding disorder.
    Description

    The patient has an uncontrolled bleeding disorder.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3842135
    The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
    Description

    The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [2,1]
    C0006826
    UMLS CUI [2,2]
    C0445356
    UMLS CUI [3]
    C1321605
    UMLS CUI [4,1]
    C0035647
    UMLS CUI [4,2]
    C1883420
    Use of any investigational or non-registered product (drug or vaccine) other than the study medication within the 30 days preceding the first dose of study treatment or planned use during the study period.
    Description

    Use of any investigational or non-registered product (drug or vaccine) other than the study medication within the 30 days preceding the first dose of study treatment or planned use during the study period.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    UMLS CUI [2]
    C0013227
    UMLS CUI [3]
    C0042210
    Concurrently participating in another clinical study, at any time during the study period, in which the patient has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
    Description

    Study Subject Participation Status; Investigational New Drugs; Pharmaceutical Preparations

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0013227
    For female patients: the patient is pregnant or lactating.
    Description

    For female patients: the patient is pregnant or lactating.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0006147
    Back to the top of the page

    Similar models

    Eligibility Check

    1 forms
    1. StudyEvent: ODM
      1. Eligibility Check
    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
    Eligibility Check
    C0013893 (UMLS CUI-1)
    Did the patient meet all the entry criteria?
    Item
    Did the patient meet all the entry criteria?
    boolean
    C1516637 (UMLS CUI [1])
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    Male or female patients with histologically proven metastatic cutaneous melanoma that is measurable
    Item
    Male or female patients with histologically proven metastatic cutaneous melanoma that is measurable
    boolean
    C0205462 (UMLS CUI [1])
    C0456369 (UMLS CUI [2])
    C0151779 (UMLS CUI [3,1])
    C0027627 (UMLS CUI [3,2])
    C1513041 (UMLS CUI [4])
    Regional lymph node metastasis present; Cutaneous | Regional lymph node metastasis present; subcutaneous | Distant metastasis present; Cutaneous | Distant metastasis present; subcutaneous | Disease; Operative Surgical Procedures; Cure (remedy) | AJCC tumor staging | Unresectable; Stage level 3; melanoma | In-Transit Metastasis | melanoma; Stage level 4; Metastasis stage M1a
    Item
    Patients with regional or distant cutaneous, subcutaneous or lymph-node metastasis can be included in the study, provided the disease is not amenable to curative treatment with surgery. In terms of the AJCC 2002 classification [AJCC, 2002], this includes patients with unresectable stage III melanoma including in-transit metastases or patient with stage IV M1a melanoma.
    boolean
    C1275854 (UMLS CUI [1,1])
    C0221912 (UMLS CUI [1,2])
    C1275854 (UMLS CUI [2,1])
    C0443315 (UMLS CUI [2,2])
    C1275402 (UMLS CUI [3,1])
    C0221912 (UMLS CUI [3,2])
    C1275402 (UMLS CUI [4,1])
    C0443315 (UMLS CUI [4,2])
    C0012634 (UMLS CUI [5,1])
    C0543467 (UMLS CUI [5,2])
    C1880198 (UMLS CUI [5,3])
    C0441915 (UMLS CUI [6])
    C1519810 (UMLS CUI [7,1])
    C0441771 (UMLS CUI [7,2])
    C0025202 (UMLS CUI [7,3])
    C2985554 (UMLS CUI [8])
    C0025202 (UMLS CUI [9,1])
    C0441772 (UMLS CUI [9,2])
    C0445036 (UMLS CUI [9,3])
    Written informed consent obtained from the patient prior to performance of any study specific procedure.
    Item
    Written informed consent obtained from the patient prior to performance of any study specific procedure.
    boolean
    C0021430 (UMLS CUI [1])
    Patient is ≥ 18 years at the time of signature of the informed consent form.
    Item
    Patient is ≥ 18 years at the time of signature of the informed consent form.
    boolean
    C0001779 (UMLS CUI [1])
    C0021430 (UMLS CUI [2])
    The patient’s tumor expresses MAGE-A3, as determined by RT-PCR analysis on a fresh tumor tissue sample obtained during the screening phase.
    Item
    The patient’s tumor expresses MAGE-A3, as determined by RT-PCR analysis on a fresh tumor tissue sample obtained during the screening phase.
    boolean
    C0962473 (UMLS CUI [1,1])
    C0017262 (UMLS CUI [1,2])
    C0599161 (UMLS CUI [2])
    C1292533 (UMLS CUI [3,1])
    C2827486 (UMLS CUI [3,2])
    C0220908 (UMLS CUI [4])
    Fresh tissue from the same lesion must be available for MAGE-A3 expression testing and for the testing of the predictive gene signature
    Item
    Fresh tissue from the same lesion must be available for MAGE-A3 expression testing and for the testing of the predictive gene signature
    boolean
    C1292533 (UMLS CUI [1,1])
    C2827486 (UMLS CUI [1,2])
    C0221198 (UMLS CUI [2,1])
    C0445247 (UMLS CUI [2,2])
    C0962473 (UMLS CUI [3,1])
    C0017262 (UMLS CUI [3,2])
    C1708225 (UMLS CUI [4,1])
    C0681890 (UMLS CUI [4,2])
    Formalin-fixed paraffin-embedded tissue specimen; Availability of | MAGEA3 protein, human; Laboratory Procedures | Gene Signature; Laboratory Procedures | C0221198 Lesion; Same | Tissue specimen; Fresh Specimen | Lesion; second (number) | Screening procedure
    Item
    Formalin-fixed paraffin-embedded (FFPE) tissue must be available for complementary MAGE-A3 and gene signature testing.This FFPE tissue should preferably come from the same (reference) lesion as the fresh tissue used for MAGE-A3 and gene signature testing but may be taken from a second lesion during the screening phase if the reference lesion does not provide sufficient tissue.
    boolean
    C2711483 (UMLS CUI [1,1])
    C0470187 (UMLS CUI [1,2])
    C0962473 (UMLS CUI [2,1])
    C0022885 (UMLS CUI [2,2])
    C1708225 (UMLS CUI [3,1])
    C0022885 (UMLS CUI [3,2])
    C0221198 (UMLS CUI [4,1])
    C0445247 (UMLS CUI [4,2])
    C1292533 (UMLS CUI [5,1])
    C2827486 (UMLS CUI [5,2])
    C0221198 (UMLS CUI [6,1])
    C0205436 (UMLS CUI [6,2])
    C0220908 (UMLS CUI [7])
    Patient fully recovered from any previous intervention (i.e., biopsy).
    Item
    Patient fully recovered from any previous intervention (i.e., biopsy).
    boolean
    C2826210 (UMLS CUI [1,1])
    C1514463 (UMLS CUI [1,2])
    C0005558 (UMLS CUI [2])
    Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    Item
    Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    boolean
    C1520224 (UMLS CUI [1])
    Bone Marrow; Adequate | Renal function; Adequate | Liver function; Adequate | Laboratory; criteria; Standard (qualifier) | Absolute neutrophil count | Platelet Count measurement | Creatinine measurement, serum (procedure) | Bilirubin, total measurement | Lactate dehydrogenase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Upper Limit of Normal
    Item
    Adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria, and defined as: - Absolute neutrophil count ≥ 1.5 x 109/L - Platelet count ≥ 75 x 109/L - Serum creatinine ≤ 1.5 times the Upper Limit of Normal (ULN) - Total bilirubin ≤ 1.5 times the ULN - Lactate Dehydrogenase (LDH) LDH ≤ ULN - Alanine transaminase (ALAT) ≤ 2.5 times the ULN - Aspartate aminotransferase (ASAT) ≤ 2.5 times ULN
    boolean
    C0005953 (UMLS CUI [1,1])
    C0205411 (UMLS CUI [1,2])
    C0232804 (UMLS CUI [2,1])
    C0205411 (UMLS CUI [2,2])
    C0232741 (UMLS CUI [3,1])
    C0205411 (UMLS CUI [3,2])
    C0022877 (UMLS CUI [4,1])
    C0243161 (UMLS CUI [4,2])
    C1442989 (UMLS CUI [4,3])
    C0948762 (UMLS CUI [5])
    C0032181 (UMLS CUI [6])
    C0201976 (UMLS CUI [7])
    C0201913 (UMLS CUI [8])
    C0202113 (UMLS CUI [9])
    C0201836 (UMLS CUI [10])
    C0201899 (UMLS CUI [11])
    C1519815 (UMLS CUI [12])
    Childbearing Potential | Tubal Ligation | Hysterectomy | Ovariectomy | Postmenopausal state | Contraceptive methods | Pregnancy test negative
    Item
    If the patient is female, she must be of non-childbearing potential, i.e., have a current tubal ligation, hysterectomy, ovariectomy or be post menopausal, or if she is of childbearing potential, she must practice adequate contraception for at least 30 days prior to registration in the trial, have a negative pregnancy test and continue such precautions during the entire study treatment period and for 2 months after completion of the injection series.
    boolean
    C3831118 (UMLS CUI [1])
    C0520483 (UMLS CUI [2])
    C0020699 (UMLS CUI [3])
    C0029936 (UMLS CUI [4])
    C0232970 (UMLS CUI [5])
    C0700589 (UMLS CUI [6])
    C0427780 (UMLS CUI [7])
    In the opinion of the investigator, the patient can and will comply with the protocol requirements.
    Item
    In the opinion of the investigator, the patient can and will comply with the protocol requirements.
    boolean
    C0582783 (UMLS CUI [1])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    Patients with unresectable stage IV M1b,c melanoma and patients with ocular and mucosal melanoma.
    Item
    Patients with unresectable stage IV M1b,c melanoma and patients with ocular and mucosal melanoma.
    boolean
    C0025202 (UMLS CUI [1,1])
    C1519810 (UMLS CUI [1,2])
    C0441772 (UMLS CUI [2,1])
    C0441971 (UMLS CUI [2,2])
    C0558356 (UMLS CUI [3])
    C3898222 (UMLS CUI [4])
    cancer treatment; Systemic | Interferon | Anti-CTLA-4 Monoclonal Antibody | Therapeutic radiology procedure; Local; regional | Adjuvant therapy; Before | Dosage; Last | Cancer Vaccines | Tumor Antigens | MAGEA3 protein, human | Isolated limb perfusion
    Item
    The patient has at any time received any systemic anticancer treatment. • Prior systemic treatment with an immunomodulator (i.e., interferon or/and anti-CTL-A4 therapy) or loco-regional radiotherapy is permitted as prior adjuvant treatment provided that the last dose was administered at least 30 days before the registration into this trial; • Previous adjuvant treatment with a cancer vaccine containing a tumor antigen other than MAGE-A3 is allowed if the last administration took place at least 8 weeks before registration into the trial. • Prior isolated limb perfusion is permitted provided that the last dose was administered at least 30 days before registration into this trial.
    boolean
    C0920425 (UMLS CUI [1,1])
    C0205373 (UMLS CUI [1,2])
    C3652465 (UMLS CUI [2])
    C4289973 (UMLS CUI [3])
    C1522449 (UMLS CUI [4,1])
    C0205276 (UMLS CUI [4,2])
    C0205147 (UMLS CUI [4,3])
    C0677850 (UMLS CUI [5,1])
    C0332152 (UMLS CUI [5,2])
    C0178602 (UMLS CUI [6,1])
    C1517741 (UMLS CUI [6,2])
    C0376659 (UMLS CUI [7])
    C0041361 (UMLS CUI [8])
    C0962473 (UMLS CUI [9])
    C0396670 (UMLS CUI [10])
    The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, other immunotherapy, chemotherapy and immunomodulating agents.
    Item
    The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, other immunotherapy, chemotherapy and immunomodulating agents.
    boolean
    C0920425 (UMLS CUI [1,1])
    C0205369 (UMLS CUI [1,2])
    C1522449 (UMLS CUI [2])
    C0021083 (UMLS CUI [3,1])
    C0205394 (UMLS CUI [3,2])
    C3665472 (UMLS CUI [4])
    C0021081 (UMLS CUI [5])
    Concomitant Therapy; chronic | systemic steroids | Immunosuppressive Agents; Other | prednisone; Medication dose | topical steroids
    Item
    The patient requires concomitant chronic treatment (more than 7 consecutive days) with systemic corticosteroids, or any other immunosuppressive agents. The use of prednisone, or equivalent, at a dose of ≤ 0.125 mg/kg/day (absolute maximum 10 mg/day) or topical steroids is permitted.
    boolean
    C1707479 (UMLS CUI [1,1])
    C0205191 (UMLS CUI [1,2])
    C2825233 (UMLS CUI [2])
    C0021081 (UMLS CUI [3,1])
    C0205394 (UMLS CUI [3,2])
    C0032952 (UMLS CUI [4,1])
    C3174092 (UMLS CUI [4,2])
    C2064827 (UMLS CUI [5])
    The patient has a history of autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
    Item
    The patient has a history of autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
    boolean
    C0004364 (UMLS CUI [1])
    C0026769 (UMLS CUI [2])
    C0409974 (UMLS CUI [3])
    C0021390 (UMLS CUI [4])
    C0042900 (UMLS CUI [5])
    The patient has a family history of congenital or hereditary immunodeficiency.
    Item
    The patient has a family history of congenital or hereditary immunodeficiency.
    boolean
    C0853602 (UMLS CUI [1])
    C0021051 (UMLS CUI [2,1])
    C0439660 (UMLS CUI [2,2])
    The patient is known to be positive for Human Immunodeficiency Virus (HIV).
    Item
    The patient is known to be positive for Human Immunodeficiency Virus (HIV).
    boolean
    C0019699 (UMLS CUI [1])
    History of allergic disease or reactions likely to be exacerbated by any component of the ASCI treatment.
    Item
    History of allergic disease or reactions likely to be exacerbated by any component of ASCI treatment.
    boolean
    C0020517 (UMLS CUI [1])
    C0020517 (UMLS CUI [2,1])
    C4086268 (UMLS CUI [2,2])
    C1705248 (UMLS CUI [3])
    C0872278 (UMLS CUI [4,1])
    C0439859 (UMLS CUI [4,2])
    Comorbidity; Malignant Neoplasms | Anatomic Site; Other | Skin carcinoma | Carcinoma in situ of uterine cervix
    Item
    The patient has previous or concomitant malignancies at other sites, except • Effectively treated non-melanoma skin cancer or carcinoma in situ of the cervix • Effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
    boolean
    C0009488 (UMLS CUI [1,1])
    C0006826 (UMLS CUI [1,2])
    C1515974 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0699893 (UMLS CUI [3])
    C0851140 (UMLS CUI [4])
    The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.
    Item
    The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.
    boolean
    C0004936 (UMLS CUI [1])
    C0085281 (UMLS CUI [2])
    C0021430 (UMLS CUI [3])
    The patient has an uncontrolled bleeding disorder.
    Item
    The patient has an uncontrolled bleeding disorder.
    boolean
    C3842135 (UMLS CUI [1])
    The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
    Item
    The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
    boolean
    C0009488 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0006826 (UMLS CUI [2,1])
    C0445356 (UMLS CUI [2,2])
    C1321605 (UMLS CUI [3])
    C0035647 (UMLS CUI [4,1])
    C1883420 (UMLS CUI [4,2])
    Use of any investigational or non-registered product (drug or vaccine) other than the study medication within the 30 days preceding the first dose of study treatment or planned use during the study period.
    Item
    Use of any investigational or non-registered product (drug or vaccine) other than the study medication within the 30 days preceding the first dose of study treatment or planned use during the study period.
    boolean
    C0013230 (UMLS CUI [1])
    C0013227 (UMLS CUI [2])
    C0042210 (UMLS CUI [3])
    Study Subject Participation Status; Investigational New Drugs; Pharmaceutical Preparations
    Item
    Concurrently participating in another clinical study, at any time during the study period, in which the patient has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
    boolean
    C2348568 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [1,3])
    For female patients: the patient is pregnant or lactating.
    Item
    For female patients: the patient is pregnant or lactating.
    boolean
    C0032961 (UMLS CUI [1,1])
    C0006147 (UMLS CUI [1,2])
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial