ID

34574

Description

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

Keywords

  1. 1/19/19 1/19/19 -
  2. 5/28/21 5/28/21 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

January 19, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Squamous Cell Carcinoma of the Head and Neck NCT02454179

Eligibility Squamous Cell Carcinoma of the Head and Neck NCT02454179

Inclusion Criteria
Description

Inclusion Criteria

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

ID.1

Data type

boolean

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
Description

ID.2

Data type

boolean

presence of radiographically measurable disease as defined by recist 1.1
Description

ID.3

Data type

boolean

ecog performance status of 0 or 1
Description

ID.4

Data type

boolean

Exclusion Criteria
Description

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
Description

ID.5

Data type

boolean

known central nervous system metastases and/or carcinomatous meningitis
Description

ID.6

Data type

boolean

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
Description

ID.7

Data type

boolean

significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of starting study drug
Description

ID.8

Data type

boolean

Similar models

Eligibility Squamous Cell Carcinoma of the Head and Neck NCT02454179

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
men and women ≥ 18 years of age
boolean
ID.2
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
ID.3
Item
presence of radiographically measurable disease as defined by recist 1.1
boolean
ID.4
Item
ecog performance status of 0 or 1
boolean
Item Group
C0680251 (UMLS CUI)
ID.5
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
ID.6
Item
known central nervous system metastases and/or carcinomatous meningitis
boolean
ID.7
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
ID.8
Item
significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of starting study drug
boolean

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