Did the patient meet all the entry criteria?
Item
Did the patient meet all the entry criteria?
boolean
C1516637 (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
C1546957 (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])
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])