ID

36366

Beskrivning

Safety Study of MGA271 in Combination With Ipilimumab in Refractory Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02381314

Länk

https://clinicaltrials.gov/show/NCT02381314

Nyckelord

Versioner (1)
  1. 2019-05-07 2019-05-07 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

7 maj 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Melanoma NCT02381314

Engelsk

Eligibility Melanoma NCT02381314

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Melanoma NCT02381314
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically-proven, unresectable, locally advanced or metastatic melanoma, scchn, or nsclc that express b7-h3.
Beskrivning

Melanoma Advanced Locally unresectable | Metastatic melanoma unresectable | Squamous cell carcinoma of the head and neck | Non-Small Cell Lung Carcinoma CD276 gene Expression

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025202
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [1,4]
C1519810
UMLS CUI [2,1]
C0278883
UMLS CUI [2,2]
C1519810
UMLS CUI [3]
C1168401
UMLS CUI [4,1]
C0007131
UMLS CUI [4,2]
C1540293
UMLS CUI [4,3]
C0017262
melanoma that has progressed within 90 days with progression on a checkpoint inhibitor (e.g., anti-pd-l1, anti-pd-1, anti-ctla-4) as the most recent prior therapy
Beskrivning

Melanoma Progressive | Disease Progression | Other Coding | Anti-PD-L1 | Anti-PD1 | Anti-CTLA-4 | Prior Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025202
UMLS CUI [1,2]
C0205329
UMLS CUI [2]
C0242656
UMLS CUI [3]
C3846158
UMLS CUI [4]
C4289971
UMLS CUI [5]
C4289970
UMLS CUI [6]
C4289973
UMLS CUI [7]
C1514463
schnn or nsclc that has progressed during or following 1 - 5 prior systemic regimens
Beskrivning

Squamous cell carcinoma of the head and neck | Non-Small Cell Lung Carcinoma | Disease Progression Following Systemic therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1168401
UMLS CUI [2]
C0007131
UMLS CUI [3,1]
C0242656
UMLS CUI [3,2]
C0332282
UMLS CUI [3,3]
C1515119
measurable disease per recist 1.1 criteria
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
ecog performance status 0 or 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
acceptable laboratory parameters and adequate organ reserve.
Beskrivning

Laboratory Results Acceptable | Organ function Mass

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1879533
UMLS CUI [2,1]
C0678852
UMLS CUI [2,2]
C1306372
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a history of symptomatic central nervous system metastases, unless treated and asymptomatic
Beskrivning

CNS metastases Symptomatic | Exception CNS metastases Treated | Exception CNS metastases Asymptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0686377
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0686377
UMLS CUI [3,3]
C0231221
patients with history of autoimmune disease with certain exceptions
Beskrivning

Autoimmune Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0004364
history of allogeneic bone marrow, stem cell, or solid organ transplant
Beskrivning

Allogeneic bone marrow transplantation | Stem cell transplant | Solid organ transplant

Datatyp

boolean

Alias
UMLS CUI [1]
C0149615
UMLS CUI [2]
C1504389
UMLS CUI [3]
C0730400
treatment with systemic cancer therapy or investigational therapy within 4 weeks; radiation within 2 weeks; trauma or major surgery within 4 weeks
Beskrivning

Cancer treatment Systemic | Therapy, Investigational | Therapeutic radiology procedure | Trauma Surgery | Major surgery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C0949266
UMLS CUI [3]
C1522449
UMLS CUI [4,1]
C3714660
UMLS CUI [4,2]
C0543467
UMLS CUI [5]
C0679637
history of clinically-significant cardiovascular disease; gastrointestinal perforation; gastrointestinal bleeding, acute pancreatitis or diverticulitis within 4 weeks;
Beskrivning

Cardiovascular Disease | Gastrointestinal perforation | Gastrointestinal Hemorrhage | Pancreatitis | Diverticulitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0151664
UMLS CUI [3]
C0017181
UMLS CUI [4]
C0030305
UMLS CUI [5]
C0012813
active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days; positive for human immunodeficiency virus or aids, hepatitis b or c.
Beskrivning

Virus Disease | Bacterial Infection | Systemic mycosis | Requirement Parenteral therapy | HIV Seropositivity | Hepatitis B positive | Hepatitis C positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0042769
UMLS CUI [2]
C0004623
UMLS CUI [3]
C0553576
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0259961
UMLS CUI [5]
C0019699
UMLS CUI [6]
C0856706
UMLS CUI [7]
C1112419
known hypersensitivity to recombinant proteins, polysorbate 80, or any excipient contained in the drug or vehicle formulation for mga271 or ipilimumab.
Beskrivning

Hypersensitivity Recombinant Proteins | Hypersensitivity Polysorbate 80 | Hypersensitivity Excipient MGA271 | Hypersensitivity Excipient Ipilimumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0034861
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0032601
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0015237
UMLS CUI [3,3]
C3273458
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0015237
UMLS CUI [4,3]
C1367202
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Similar models

Eligibility Melanoma NCT02381314

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Melanoma NCT02381314
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Melanoma Advanced Locally unresectable | Metastatic melanoma unresectable | Squamous cell carcinoma of the head and neck | Non-Small Cell Lung Carcinoma CD276 gene Expression
Item
histologically-proven, unresectable, locally advanced or metastatic melanoma, scchn, or nsclc that express b7-h3.
boolean
C0025202 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C1519810 (UMLS CUI [1,4])
C0278883 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C1168401 (UMLS CUI [3])
C0007131 (UMLS CUI [4,1])
C1540293 (UMLS CUI [4,2])
C0017262 (UMLS CUI [4,3])
Melanoma Progressive | Disease Progression | Other Coding | Anti-PD-L1 | Anti-PD1 | Anti-CTLA-4 | Prior Therapy
Item
melanoma that has progressed within 90 days with progression on a checkpoint inhibitor (e.g., anti-pd-l1, anti-pd-1, anti-ctla-4) as the most recent prior therapy
boolean
C0025202 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
C4289971 (UMLS CUI [4])
C4289970 (UMLS CUI [5])
C4289973 (UMLS CUI [6])
C1514463 (UMLS CUI [7])
Squamous cell carcinoma of the head and neck | Non-Small Cell Lung Carcinoma | Disease Progression Following Systemic therapy
Item
schnn or nsclc that has progressed during or following 1 - 5 prior systemic regimens
boolean
C1168401 (UMLS CUI [1])
C0007131 (UMLS CUI [2])
C0242656 (UMLS CUI [3,1])
C0332282 (UMLS CUI [3,2])
C1515119 (UMLS CUI [3,3])
Measurable Disease
Item
measurable disease per recist 1.1 criteria
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Laboratory Results Acceptable | Organ function Mass
Item
acceptable laboratory parameters and adequate organ reserve.
boolean
C1254595 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C0678852 (UMLS CUI [2,1])
C1306372 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
CNS metastases Symptomatic | Exception CNS metastases Treated | Exception CNS metastases Asymptomatic
Item
patients with a history of symptomatic central nervous system metastases, unless treated and asymptomatic
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0686377 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0686377 (UMLS CUI [3,2])
C0231221 (UMLS CUI [3,3])
Autoimmune Disease
Item
patients with history of autoimmune disease with certain exceptions
boolean
C0004364 (UMLS CUI [1])
Allogeneic bone marrow transplantation | Stem cell transplant | Solid organ transplant
Item
history of allogeneic bone marrow, stem cell, or solid organ transplant
boolean
C0149615 (UMLS CUI [1])
C1504389 (UMLS CUI [2])
C0730400 (UMLS CUI [3])
Cancer treatment Systemic | Therapy, Investigational | Therapeutic radiology procedure | Trauma Surgery | Major surgery
Item
treatment with systemic cancer therapy or investigational therapy within 4 weeks; radiation within 2 weeks; trauma or major surgery within 4 weeks
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0949266 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C3714660 (UMLS CUI [4,1])
C0543467 (UMLS CUI [4,2])
C0679637 (UMLS CUI [5])
Cardiovascular Disease | Gastrointestinal perforation | Gastrointestinal Hemorrhage | Pancreatitis | Diverticulitis
Item
history of clinically-significant cardiovascular disease; gastrointestinal perforation; gastrointestinal bleeding, acute pancreatitis or diverticulitis within 4 weeks;
boolean
C0007222 (UMLS CUI [1])
C0151664 (UMLS CUI [2])
C0017181 (UMLS CUI [3])
C0030305 (UMLS CUI [4])
C0012813 (UMLS CUI [5])
Virus Disease | Bacterial Infection | Systemic mycosis | Requirement Parenteral therapy | HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Item
active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days; positive for human immunodeficiency virus or aids, hepatitis b or c.
boolean
C0042769 (UMLS CUI [1])
C0004623 (UMLS CUI [2])
C0553576 (UMLS CUI [3])
C1514873 (UMLS CUI [4,1])
C0259961 (UMLS CUI [4,2])
C0019699 (UMLS CUI [5])
C0856706 (UMLS CUI [6])
C1112419 (UMLS CUI [7])
Hypersensitivity Recombinant Proteins | Hypersensitivity Polysorbate 80 | Hypersensitivity Excipient MGA271 | Hypersensitivity Excipient Ipilimumab
Item
known hypersensitivity to recombinant proteins, polysorbate 80, or any excipient contained in the drug or vehicle formulation for mga271 or ipilimumab.
boolean
C0020517 (UMLS CUI [1,1])
C0034861 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0032601 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0015237 (UMLS CUI [3,2])
C3273458 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0015237 (UMLS CUI [4,2])
C1367202 (UMLS CUI [4,3])
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