ID

36412

Descripción

A Study of Nivolumab and Nivolumab Plus Ipilimumab in Recurrent and Metastatic Colon Cancer (CheckMate 142); ODM derived from: https://clinicaltrials.gov/show/NCT02060188

Link

https://clinicaltrials.gov/show/NCT02060188

Palabras clave

Versiones (1)
  1. 12/5/19 12/5/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

12 de mayo de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility MSI Positive Colorectal Cancer NCT02060188

Inglés

Eligibility MSI Positive Colorectal Cancer NCT02060188

1 formularios  
Criteria
Descripción

Criteria

Inclusion Criteria
Descripción

Inclusion Criteria

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

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance status 0 to 1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
histologically confirmed colorectal cancer
Descripción

Colorectal Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009402
measurable disease by ct or mri
Descripción

Measurable Disease CT | Measurable Disease MRI

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0024485
testing for msi status
Descripción

Microsatellite instability diagnostic test

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0796369
adequate organ function as defined by study-specific laboratory tests
Descripción

Organ function Laboratory Procedures

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0022885
must use acceptable form of birth control throughout the study. after the final dose of study drug, an acceptable form of birth control must be used for 23 weeks for women of childbearing potential (wocbp) and 31 weeks for men who are sexually active with wocbp
Descripción

Childbearing Potential Contraceptive methods | Gender Partner Childbearing Potential | Gender Sexually active Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0682323
UMLS CUI [2,3]
C3831118
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0241028
UMLS CUI [3,3]
C0700589
signed informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
willing and able to comply with study procedures
Descripción

Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
active brain metastases or leptomeningeal metastases are not allowed.
Descripción

Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C1704231
prior treatment with an anti-programmed death receptor (pd)-1, anti-pd-l1, anti-pd-l2, anti-cytotoxic t-cell lymphoma-4 antigen (ctla-4) antibody, or any other antibody or drug specifically targeting t-cell co-stimulation or immune checkpoint pathways
Descripción

Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | PD-L2 Monoclonal Antibody | Anti-CTLA-4 Monoclonal Antibody

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4289970
UMLS CUI [2]
C4289971
UMLS CUI [3,1]
C1705357
UMLS CUI [3,2]
C0003250
UMLS CUI [4]
C4289973
prior malignancy active within the previous 3 years except for locally curable cancers
Descripción

Malignant Neoplasms | Exception Malignant Neoplasms Cured Locally

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0006826
UMLS CUI [2,3]
C1880198
UMLS CUI [2,4]
C1517927
subjects with active, known or suspected autoimmune disease
Descripción

Autoimmune Disease | Autoimmune Disease Suspected

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C0004364
UMLS CUI [2,2]
C0750491
subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration
Descripción

Condition Requirement Systemic therapy | Adrenal Cortex Hormones | Immunosuppressive Agents

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1515119
UMLS CUI [2]
C0001617
UMLS CUI [3]
C0021081
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Similar models

Eligibility MSI Positive Colorectal Cancer NCT02060188

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Age
Item
men and women ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0 to 1
boolean
C1520224 (UMLS CUI [1])
Colorectal Carcinoma
Item
histologically confirmed colorectal cancer
boolean
C0009402 (UMLS CUI [1])
Measurable Disease CT | Measurable Disease MRI
Item
measurable disease by ct or mri
boolean
C1513041 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
Microsatellite instability diagnostic test
Item
testing for msi status
boolean
C0796369 (UMLS CUI [1])
Organ function Laboratory Procedures
Item
adequate organ function as defined by study-specific laboratory tests
boolean
C0678852 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods | Gender Partner Childbearing Potential | Gender Sexually active Contraceptive methods
Item
must use acceptable form of birth control throughout the study. after the final dose of study drug, an acceptable form of birth control must be used for 23 weeks for women of childbearing potential (wocbp) and 31 weeks for men who are sexually active with wocbp
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0241028 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
willing and able to comply with study procedures
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges
Item
active brain metastases or leptomeningeal metastases are not allowed.
boolean
C0220650 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | PD-L2 Monoclonal Antibody | Anti-CTLA-4 Monoclonal Antibody
Item
prior treatment with an anti-programmed death receptor (pd)-1, anti-pd-l1, anti-pd-l2, anti-cytotoxic t-cell lymphoma-4 antigen (ctla-4) antibody, or any other antibody or drug specifically targeting t-cell co-stimulation or immune checkpoint pathways
boolean
C4289970 (UMLS CUI [1])
C4289971 (UMLS CUI [2])
C1705357 (UMLS CUI [3,1])
C0003250 (UMLS CUI [3,2])
C4289973 (UMLS CUI [4])
Malignant Neoplasms | Exception Malignant Neoplasms Cured Locally
Item
prior malignancy active within the previous 3 years except for locally curable cancers
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
C1517927 (UMLS CUI [2,4])
Autoimmune Disease | Autoimmune Disease Suspected
Item
subjects with active, known or suspected autoimmune disease
boolean
C0004364 (UMLS CUI [1])
C0004364 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Condition Requirement Systemic therapy | Adrenal Cortex Hormones | Immunosuppressive Agents
Item
subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration
boolean
C0348080 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
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