ID

42314

Beschreibung

Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Advanced Head and Neck Squamous Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02454179

Link

https://clinicaltrials.gov/show/NCT02454179

Stichworte

Versionen (2)
  1. 19.01.19 19.01.19 -
  2. 28.05.21 28.05.21 -
Rechteinhaber

Acerta Pharma BV

Hochgeladen am

28. Mai 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Squamous Cell Carcinoma of the Head and Neck NCT02454179

Englisch

Eligibility Squamous Cell Carcinoma of the Head and Neck NCT02454179

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women ≥ 18 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically or cytologically confirmed recurrent, metastatic or unresectable hnscc of the oral cavity, oropharynx, hypopharynx, and larynx that that has either progressed during or after platinum-based chemotherapy administered for metastatic disease or has recurred during or within 6 months after the completion of platinum-based neoadjuvant or adjuvant therapy
Beschreibung

Recurrent, metastatic or unresectable hnscc of the oral cavity, oropharynx, hypopharynx, and larynx | progressed post platinum-based chemotherapy | recurrent post platinum-based chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0861556
UMLS CUI [2]
C0280376
UMLS CUI [3]
C0280392
UMLS CUI [4]
C0280401
UMLS CUI [5,1]
C0585362
UMLS CUI [5,2]
C0027627
UMLS CUI [6,1]
C0280313
UMLS CUI [6,2]
C0027627
UMLS CUI [7,1]
C0280321
UMLS CUI [7,2]
C0027627
UMLS CUI [8,1]
C0280324
UMLS CUI [8,2]
C0027627
UMLS CUI [9,1]
C0585362
UMLS CUI [9,2]
C1519810
UMLS CUI [10,1]
C0280313
UMLS CUI [10,2]
C1519810
UMLS CUI [11,1]
C0280321
UMLS CUI [11,2]
C1519810
UMLS CUI [12,1]
C0280324
UMLS CUI [12,2]
C1519810
UMLS CUI [13,1]
C0242656
UMLS CUI [13,2]
C0687676
UMLS CUI [13,3]
C0392920
UMLS CUI [13,4]
C1514162
UMLS CUI [14,1]
C0277556
UMLS CUI [14,2]
C0687676
UMLS CUI [14,3]
C0392920
UMLS CUI [14,4]
C1514162
presence of radiographically measurable disease as defined by recist 1.1
Beschreibung

Radiographically measurable disease | RECIST

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0034571
UMLS CUI [2]
C1709926
ecog performance status of 0 or 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior malignancy (other than hnscc), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to < 2 years
Beschreibung

Malignant Neoplasm except for hnscc | basal cell carcinoma | squamous cell skin cancer | in situ cervical cancer | other previous malign neoplasms disease free survival

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C1168401
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0007117
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C0332300
UMLS CUI [3,3]
C0553723
UMLS CUI [4,1]
C0006826
UMLS CUI [4,2]
C0332300
UMLS CUI [4,3]
C0851140
UMLS CUI [5,1]
C0006826
UMLS CUI [5,2]
C0332300
UMLS CUI [5,3]
C0006826
UMLS CUI [5,4]
C0205156
UMLS CUI [5,5]
C0205394
UMLS CUI [5,6]
C0012634
UMLS CUI [5,7]
C0332296
UMLS CUI [5,8]
C2919552
known central nervous system metastases and/or carcinomatous meningitis
Beschreibung

CNS metastases | carcinomatous meningitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0220654
a life-threatening illness, medical condition (including psychiatric conditions) or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety
Beschreibung

Life-threatening illness | medical condition | mental disorder | organ system dysfunction | compromise patient safety judgement clinical investigator

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3846017
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [1,4]
C0022423
UMLS CUI [1,5]
C0008961
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C1113679
UMLS CUI [2,4]
C0022423
UMLS CUI [2,5]
C0008961
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C1113679
UMLS CUI [3,4]
C0022423
UMLS CUI [3,5]
C0008961
UMLS CUI [4,1]
C0460002
UMLS CUI [4,2]
C3887504
UMLS CUI [4,3]
C2945640
UMLS CUI [4,4]
C1113679
UMLS CUI [4,5]
C0022423
UMLS CUI [4,6]
C0008961
significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of starting study drug
Beschreibung

Cardiovascular disease | uncontrolled or symptomatic arrhythmias | congestive heart failure | myocardial infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0741212
UMLS CUI [4]
C0018802
UMLS CUI [5]
C0027051
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Ähnliche Modelle

Eligibility Squamous Cell Carcinoma of the Head and Neck NCT02454179

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men and women ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Recurrent, metastatic or unresectable hnscc of the oral cavity, oropharynx, hypopharynx, and larynx | progressed post platinum-based chemotherapy | recurrent post platinum-based chemotherapy
Item
histologically or cytologically confirmed recurrent, metastatic or unresectable hnscc of the oral cavity, oropharynx, hypopharynx, and larynx that that has either progressed during or after platinum-based chemotherapy administered for metastatic disease or has recurred during or within 6 months after the completion of platinum-based neoadjuvant or adjuvant therapy
boolean
C0861556 (UMLS CUI [1])
C0280376 (UMLS CUI [2])
C0280392 (UMLS CUI [3])
C0280401 (UMLS CUI [4])
C0585362 (UMLS CUI [5,1])
C0027627 (UMLS CUI [5,2])
C0280313 (UMLS CUI [6,1])
C0027627 (UMLS CUI [6,2])
C0280321 (UMLS CUI [7,1])
C0027627 (UMLS CUI [7,2])
C0280324 (UMLS CUI [8,1])
C0027627 (UMLS CUI [8,2])
C0585362 (UMLS CUI [9,1])
C1519810 (UMLS CUI [9,2])
C0280313 (UMLS CUI [10,1])
C1519810 (UMLS CUI [10,2])
C0280321 (UMLS CUI [11,1])
C1519810 (UMLS CUI [11,2])
C0280324 (UMLS CUI [12,1])
C1519810 (UMLS CUI [12,2])
C0242656 (UMLS CUI [13,1])
C0687676 (UMLS CUI [13,2])
C0392920 (UMLS CUI [13,3])
C1514162 (UMLS CUI [13,4])
C0277556 (UMLS CUI [14,1])
C0687676 (UMLS CUI [14,2])
C0392920 (UMLS CUI [14,3])
C1514162 (UMLS CUI [14,4])
Radiographically measurable disease | RECIST
Item
presence of radiographically measurable disease as defined by recist 1.1
boolean
C1513041 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
C1709926 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasm except for hnscc | basal cell carcinoma | squamous cell skin cancer | in situ cervical cancer | other previous malign neoplasms disease free survival
Item
prior malignancy (other than hnscc), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to < 2 years
boolean
C0006826 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C1168401 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
C0006826 (UMLS CUI [3,1])
C0332300 (UMLS CUI [3,2])
C0553723 (UMLS CUI [3,3])
C0006826 (UMLS CUI [4,1])
C0332300 (UMLS CUI [4,2])
C0851140 (UMLS CUI [4,3])
C0006826 (UMLS CUI [5,1])
C0332300 (UMLS CUI [5,2])
C0006826 (UMLS CUI [5,3])
C0205156 (UMLS CUI [5,4])
C0205394 (UMLS CUI [5,5])
C0012634 (UMLS CUI [5,6])
C0332296 (UMLS CUI [5,7])
C2919552 (UMLS CUI [5,8])
CNS metastases | carcinomatous meningitis
Item
known central nervous system metastases and/or carcinomatous meningitis
boolean
C0686377 (UMLS CUI [1])
C0220654 (UMLS CUI [2])
Life-threatening illness | medical condition | mental disorder | organ system dysfunction | compromise patient safety judgement clinical investigator
Item
a life-threatening illness, medical condition (including psychiatric conditions) or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety
boolean
C3846017 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,4])
C0008961 (UMLS CUI [1,5])
C3843040 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0022423 (UMLS CUI [2,4])
C0008961 (UMLS CUI [2,5])
C0004936 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C0022423 (UMLS CUI [3,4])
C0008961 (UMLS CUI [3,5])
C0460002 (UMLS CUI [4,1])
C3887504 (UMLS CUI [4,2])
C2945640 (UMLS CUI [4,3])
C1113679 (UMLS CUI [4,4])
C0022423 (UMLS CUI [4,5])
C0008961 (UMLS CUI [4,6])
Cardiovascular disease | uncontrolled or symptomatic arrhythmias | congestive heart failure | myocardial infarction
Item
significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of starting study drug
boolean
C0007222 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0741212 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
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