ID

36378

Description

Safety Study of MGA271 in Combination With Pembrolizumab in Refractory Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02475213

Link

https://clinicaltrials.gov/show/NCT02475213

Keywords

Versions (1)
  1. 5/8/19 5/8/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 8, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Melanoma NCT02475213

English

Eligibility Melanoma NCT02475213

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Melanoma NCT02475213
Inclusion Criteria
Description

Inclusion Criteria

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

Melanoma Advanced Locally unresectable | Metastatic melanoma unresectable | Squamous cell carcinoma of the head and neck | Squamous non-small cell lung cancer CD276 gene Expression

Data type

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]
C4509816
UMLS CUI [4,2]
C1540293
UMLS CUI [4,3]
C0017262
melanoma that has progressed during or following at least 1 and up to 5 prior systemic treatments for unresectable locally advanced or metastatic disease, or melanoma patients who are intolerable of or have refused standard first line cancer therapy. pre- and on-study biopsy required.
Description

Melanoma Progressive | Systemic therapy Quantity | Advanced disease Locally unresectable | Neoplasm Metastasis unresectable | Intolerance First line treatment Melanoma | Refusal of First line treatment Melanoma | Biopsy Required

Data type

boolean

Alias
UMLS CUI [1,1]
C0025202
UMLS CUI [1,2]
C0205329
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0679246
UMLS CUI [3,2]
C1517927
UMLS CUI [3,3]
C1519810
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C1519810
UMLS CUI [5,1]
C0231199
UMLS CUI [5,2]
C1708063
UMLS CUI [5,3]
C0025202
UMLS CUI [6,1]
C0040809
UMLS CUI [6,2]
C1708063
UMLS CUI [6,3]
C0025202
UMLS CUI [7,1]
C0005558
UMLS CUI [7,2]
C1514873
scchn that has progressed during or following at least 1 and up to 5 prior systemic treatments for metastatic or recurrent disease deemed to be incurable. patient who refuse radical resection for recurrent disease or are intolerant of or refused standard first line therapy are eligible to enroll
Description

Squamous cell carcinoma of the head and neck Progressive | Systemic therapy Quantity | Neoplasm Metastasis incurable | Recurrent disease incurable | Radical excision Refused Recurrent disease | Intolerance First line treatment | First line treatment Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C1168401
UMLS CUI [1,2]
C0205329
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0175969
UMLS CUI [4,1]
C0277556
UMLS CUI [4,2]
C0175969
UMLS CUI [5,1]
C0184918
UMLS CUI [5,2]
C1705116
UMLS CUI [5,3]
C0277556
UMLS CUI [6,1]
C0231199
UMLS CUI [6,2]
C1708063
UMLS CUI [7,1]
C1708063
UMLS CUI [7,2]
C1705116
squamous cell nsclc that has progressed during or following 1 - 5 prior systemic therapies for unresectable locally advanced or metastatic disease (at least one docetaxel, gemcitabine, or platinum analogue based therapy), or are intolerant of or refused standard first line cancer therapy.
Description

Squamous non-small cell lung cancer Progressive | Systemic therapy Quantity | Advanced disease Locally unresectable | Neoplasm Metastasis unresectable | docetaxel | gemcitabine | Platinum Analogue | Intolerance First line treatment | First line treatment Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C4509816
UMLS CUI [1,2]
C0205329
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0679246
UMLS CUI [3,2]
C1517927
UMLS CUI [3,3]
C1519810
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C1519810
UMLS CUI [5]
C0246415
UMLS CUI [6]
C0045093
UMLS CUI [7,1]
C0032207
UMLS CUI [7,2]
C0243071
UMLS CUI [8,1]
C0231199
UMLS CUI [8,2]
C1708063
UMLS CUI [9,1]
C1708063
UMLS CUI [9,2]
C1705116
measurable disease per recist 1.1 criteria
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
easter cooperative oncology group (ecog) performance status 0 or 1
Description

ECOG performance status

Data type

boolean

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

Laboratory Results Acceptable | Organ function Mass

Data type

boolean

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

Exclusion Criteria

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

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

Data type

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 such as vitiligo, resolved chilhood atopic dermatitis, psoriasis not requiring systemic therapy within the past 2 years, patients with history of grave's disease that are now euthyroid clinically and by lab testing
Description

Autoimmune Disease | Exception Vitiligo | Exception Childhood atopic dermatitis resolved | Exception Psoriasis Independent of Systemic therapy | Exception GRAVE DISEASE EUTHYROID

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0042900
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1276071
UMLS CUI [3,3]
C1514893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0033860
UMLS CUI [4,3]
C0332291
UMLS CUI [4,4]
C1515119
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0744480
history of allogeneic bone marrow, stem cell, or solid organ transplant
Description

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

Data type

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 of first study drug administration; radiation within 2 weeks; corticosteroids (greater than or equal to 10 mg prednisone or equivalent per day) or other immune suppressive drugs within 2 weeks of first study drug administration
Description

Cancer treatment Systemic | Therapy, Investigational | Therapeutic radiology procedure | Adrenal Cortex Hormones Dose U/day | Prednisone Equivalent | Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C0949266
UMLS CUI [3]
C1522449
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0456683
UMLS CUI [5,1]
C0032952
UMLS CUI [5,2]
C0205163
UMLS CUI [6]
C0021081
trauma or major surgery within 4 weeks of first study drug administration
Description

Trauma surgery | Major surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C3714660
UMLS CUI [1,2]
C0543467
UMLS CUI [2]
C0679637
history of clinically-significant cardiovascular disease; gastrointestinal perforation; gastrointestinal bleeding, acute pancreatitis or diverticulitis within 4 weeks of first study drug administration
Description

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

Data type

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 of first study drug administration
Description

Virus Disease | Bacterial Infection | Systemic mycosis | Requirement Parenteral therapy

Data type

boolean

Alias
UMLS CUI [1]
C0042769
UMLS CUI [2]
C0004623
UMLS CUI [3]
C0553576
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0259961
known history of hepatitis b or c infection or known positive test for hepatitis b surface antigen or core antigen, or hepatitis c polymerase chain reaction (pcr)
Description

Hepatitis B | Hepatitis C | Hepatitis B surface antigen positive | Hepatitis B core antigen positive | Hepatitis C test positive Polymerase Chain Reaction

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0149709
UMLS CUI [4]
C0262507
UMLS CUI [5,1]
C1609517
UMLS CUI [5,2]
C0032520
known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome
Description

HIV Seropositivity | Acquired Immunodeficiency Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0001175
known hypersensitivity to recombinant proteins, polysorbate 80, or any excipient contained in the drug or vehicle formulation for mga271 or pembrolizumab.
Description

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

Data type

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]
C3658706
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Similar models

Eligibility Melanoma NCT02475213

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Melanoma NCT02475213
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Melanoma Advanced Locally unresectable | Metastatic melanoma unresectable | Squamous cell carcinoma of the head and neck | Squamous non-small cell lung cancer CD276 gene Expression
Item
histologically-proven, unresectable, locally advanced or metastatic melanoma, scchn, or squamous cell 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])
C4509816 (UMLS CUI [4,1])
C1540293 (UMLS CUI [4,2])
C0017262 (UMLS CUI [4,3])
Melanoma Progressive | Systemic therapy Quantity | Advanced disease Locally unresectable | Neoplasm Metastasis unresectable | Intolerance First line treatment Melanoma | Refusal of First line treatment Melanoma | Biopsy Required
Item
melanoma that has progressed during or following at least 1 and up to 5 prior systemic treatments for unresectable locally advanced or metastatic disease, or melanoma patients who are intolerable of or have refused standard first line cancer therapy. pre- and on-study biopsy required.
boolean
C0025202 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0679246 (UMLS CUI [3,1])
C1517927 (UMLS CUI [3,2])
C1519810 (UMLS CUI [3,3])
C0027627 (UMLS CUI [4,1])
C1519810 (UMLS CUI [4,2])
C0231199 (UMLS CUI [5,1])
C1708063 (UMLS CUI [5,2])
C0025202 (UMLS CUI [5,3])
C0040809 (UMLS CUI [6,1])
C1708063 (UMLS CUI [6,2])
C0025202 (UMLS CUI [6,3])
C0005558 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
Squamous cell carcinoma of the head and neck Progressive | Systemic therapy Quantity | Neoplasm Metastasis incurable | Recurrent disease incurable | Radical excision Refused Recurrent disease | Intolerance First line treatment | First line treatment Refused
Item
scchn that has progressed during or following at least 1 and up to 5 prior systemic treatments for metastatic or recurrent disease deemed to be incurable. patient who refuse radical resection for recurrent disease or are intolerant of or refused standard first line therapy are eligible to enroll
boolean
C1168401 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0175969 (UMLS CUI [3,2])
C0277556 (UMLS CUI [4,1])
C0175969 (UMLS CUI [4,2])
C0184918 (UMLS CUI [5,1])
C1705116 (UMLS CUI [5,2])
C0277556 (UMLS CUI [5,3])
C0231199 (UMLS CUI [6,1])
C1708063 (UMLS CUI [6,2])
C1708063 (UMLS CUI [7,1])
C1705116 (UMLS CUI [7,2])
Squamous non-small cell lung cancer Progressive | Systemic therapy Quantity | Advanced disease Locally unresectable | Neoplasm Metastasis unresectable | docetaxel | gemcitabine | Platinum Analogue | Intolerance First line treatment | First line treatment Refused
Item
squamous cell nsclc that has progressed during or following 1 - 5 prior systemic therapies for unresectable locally advanced or metastatic disease (at least one docetaxel, gemcitabine, or platinum analogue based therapy), or are intolerant of or refused standard first line cancer therapy.
boolean
C4509816 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0679246 (UMLS CUI [3,1])
C1517927 (UMLS CUI [3,2])
C1519810 (UMLS CUI [3,3])
C0027627 (UMLS CUI [4,1])
C1519810 (UMLS CUI [4,2])
C0246415 (UMLS CUI [5])
C0045093 (UMLS CUI [6])
C0032207 (UMLS CUI [7,1])
C0243071 (UMLS CUI [7,2])
C0231199 (UMLS CUI [8,1])
C1708063 (UMLS CUI [8,2])
C1708063 (UMLS CUI [9,1])
C1705116 (UMLS CUI [9,2])
Measurable Disease
Item
measurable disease per recist 1.1 criteria
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
easter cooperative oncology group (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 | Exception Vitiligo | Exception Childhood atopic dermatitis resolved | Exception Psoriasis Independent of Systemic therapy | Exception GRAVE DISEASE EUTHYROID
Item
patients with history of autoimmune disease with certain exceptions such as vitiligo, resolved chilhood atopic dermatitis, psoriasis not requiring systemic therapy within the past 2 years, patients with history of grave's disease that are now euthyroid clinically and by lab testing
boolean
C0004364 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0042900 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1276071 (UMLS CUI [3,2])
C1514893 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0033860 (UMLS CUI [4,2])
C0332291 (UMLS CUI [4,3])
C1515119 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0744480 (UMLS CUI [5,2])
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 | Adrenal Cortex Hormones Dose U/day | Prednisone Equivalent | Immunosuppressive Agents
Item
treatment with systemic cancer therapy or investigational therapy within 4 weeks of first study drug administration; radiation within 2 weeks; corticosteroids (greater than or equal to 10 mg prednisone or equivalent per day) or other immune suppressive drugs within 2 weeks of first study drug administration
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0949266 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0001617 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0456683 (UMLS CUI [4,3])
C0032952 (UMLS CUI [5,1])
C0205163 (UMLS CUI [5,2])
C0021081 (UMLS CUI [6])
Trauma surgery | Major surgery
Item
trauma or major surgery within 4 weeks of first study drug administration
boolean
C3714660 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0679637 (UMLS CUI [2])
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 of first study drug administration
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
Item
active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days of first study drug administration
boolean
C0042769 (UMLS CUI [1])
C0004623 (UMLS CUI [2])
C0553576 (UMLS CUI [3])
C1514873 (UMLS CUI [4,1])
C0259961 (UMLS CUI [4,2])
Hepatitis B | Hepatitis C | Hepatitis B surface antigen positive | Hepatitis B core antigen positive | Hepatitis C test positive Polymerase Chain Reaction
Item
known history of hepatitis b or c infection or known positive test for hepatitis b surface antigen or core antigen, or hepatitis c polymerase chain reaction (pcr)
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0149709 (UMLS CUI [3])
C0262507 (UMLS CUI [4])
C1609517 (UMLS CUI [5,1])
C0032520 (UMLS CUI [5,2])
HIV Seropositivity | Acquired Immunodeficiency Syndrome
Item
known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome
boolean
C0019699 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
Hypersensitivity Recombinant Proteins | Hypersensitivity Polysorbate 80 | Hypersensitivity Excipient MGA271 | Hypersensitivity Excipient Pembrolizumab
Item
known hypersensitivity to recombinant proteins, polysorbate 80, or any excipient contained in the drug or vehicle formulation for mga271 or pembrolizumab.
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])
C3658706 (UMLS CUI [4,3])
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