ID

36547

Description

Phase II Study of PD-1 Blockade Alone or In Conjunction With the Dendritic Cell (DC)/Renal Cell Carcinoma (RCC) Fusion Cell Vaccination; ODM derived from: https://clinicaltrials.gov/show/NCT01441765

Link

https://clinicaltrials.gov/show/NCT01441765

Keywords

Versions (2)
  1. 1/19/19 1/19/19 -
  2. 5/21/19 5/21/19 -
Copyright Holder

Beth Israel Deaconess Medical Center

Uploaded on

May 21, 2019

DOI

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License

Creative Commons BY-NC 3.0
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DC/RCC Fusion Vaccine in Renal Cell Carcinoma NCT01441765

English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
stage IV renal cancer
Description

Stage IV renal cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C1378703
UMLS CUI [1,2]
C0475266
measurable disease
Description

Measurable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
life expectancy > 3 months
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
adequate organ and marrow function
Description

adequate organ and marrow function

Data type

boolean

Alias
UMLS CUI [1,1]
C0031843
UMLS CUI [1,2]
C0678852
UMLS CUI [2,1]
C0031843
UMLS CUI [2,2]
C0005953
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Clinical evidence of central nervous system (CNS) disease
Description

Subjects with a history of treated brain metastasis must be stable with no evidence of disease for 3 months

Data type

boolean

Alias
UMLS CUI [1,1]
C0332120
UMLS CUI [1,2]
C0007682
clinically significant autoimmune disease
Description

clinically significant autoimmune disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C2826293
HIV+
Description

HIV positive

Data type

boolean

Alias
UMLS CUI [1]
C0019699
Serious intercurrent illness such as infection requiring intravenous (IV) antibiotics
Description

Serious intercurrent illness such as infection requiring intravenous antibiotics

Data type

boolean

Alias
UMLS CUI [1]
C3640977
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0003232
UMLS CUI [2,4]
C1522726
Serious intercurrent illness such as significant cardiac disease characterized by significant arrhythmia, uncontrolled hypertension, unstable ischemic coronary disease or congestive heart failure
Description

Serious intercurrent illness such as significant cardiac disease characterized by significant arrhythmia, uncontrolled hypertension, unstable ischemic coronary disease or congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C3640977
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0750502
UMLS CUI [3,1]
C0750502
UMLS CUI [3,2]
C0003811
UMLS CUI [4]
C1868885
UMLS CUI [5,1]
C1956346
UMLS CUI [5,2]
C0443343
UMLS CUI [6]
C0018802
pregnant or lactating
Description

pregnant or lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of clinically significant venous thromboembolism (for cohort 2)
Description

history of clinically significant venous thromboembolism

Data type

boolean

Alias
UMLS CUI [1,1]
C1861172
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0262926
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Stage IV renal cancer
Item
stage IV renal cancer
boolean
C1378703 (UMLS CUI [1,1])
C0475266 (UMLS CUI [1,2])
Measurable disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
life expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
adequate organ and marrow function
Item
adequate organ and marrow function
boolean
C0031843 (UMLS CUI [1,1])
C0678852 (UMLS CUI [1,2])
C0031843 (UMLS CUI [2,1])
C0005953 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Evidence of CNS disease
Item
Clinical evidence of central nervous system (CNS) disease
boolean
C0332120 (UMLS CUI [1,1])
C0007682 (UMLS CUI [1,2])
clinically significant autoimmune disease
Item
clinically significant autoimmune disease
boolean
C0004364 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
HIV positive
Item
HIV+
boolean
C0019699 (UMLS CUI [1])
Serious intercurrent illness such as infection requiring intravenous antibiotics
Item
Serious intercurrent illness such as infection requiring intravenous (IV) antibiotics
boolean
C3640977 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003232 (UMLS CUI [2,3])
C1522726 (UMLS CUI [2,4])
Serious intercurrent illness such as significant cardiac disease characterized by significant arrhythmia, uncontrolled hypertension, unstable ischemic coronary disease or congestive heart failure
Item
Serious intercurrent illness such as significant cardiac disease characterized by significant arrhythmia, uncontrolled hypertension, unstable ischemic coronary disease or congestive heart failure
boolean
C3640977 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0750502 (UMLS CUI [3,1])
C0003811 (UMLS CUI [3,2])
C1868885 (UMLS CUI [4])
C1956346 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0018802 (UMLS CUI [6])
pregnant or lactating
Item
pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
history of clinically significant venous thromboembolism
Item
history of clinically significant venous thromboembolism (for cohort 2)
boolean
C1861172 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
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