ID

44482

Beskrivning

Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Combination With Pembrolizumab in Subjects With Metastatic Triple-Negative Breast Cancer (mTNBC); ODM derived from: https://clinicaltrials.gov/show/NCT02513472

Länk

https://clinicaltrials.gov/show/NCT02513472

Nyckelord

Versioner (2)
  1. 2018-01-20 2018-01-20 -
  2. 2021-09-27 2021-09-27 -
Rättsinnehavare

https://clinicaltrials.gov/show/NCT02513472

Uppladdad den

27 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02513472

Engelsk

Eligibility Breast Cancer NCT02513472

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. females or males, aged greater than or equal to 18 years at the time of signing the informed consent form (icf)
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. metastatic triple-negative, ie, estrogen receptor (er) negative/ progesterone receptor negative / human epidermal growth factor receptor 2 (her2) -negative (defined as immunohistochemistry [ihc] less than 2+ or fluorescence in situ hybridization [fish] negative) breast cancer previously treated with 0 to 2 lines of chemotherapy in the metastatic setting
Beskrivning

triple negative breast cancer chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348819
UMLS CUI [1,2]
C0392920
3. presence of measurable disease meeting the following criteria:
Beskrivning

criteria for measurable disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
1. at least 1 lesion of greater than or equal to 10 mm in long axis diameter for nonlymph nodes or greater than or equal to 15 mm in short axis diameter for lymph nodes that is serially measurable according to recist 1.1 using computerized tomography or magnetic resonance imaging or panoramic and close-up color photography
Beskrivning

lymph node or nonlymph node lesion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0221198
UMLS CUI [2,1]
C0040300
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0221198
2. lesions that have had radiotherapy must show subsequent radiographic evidence of increased size to be deemed a target lesion
Beskrivning

lesion size after radiotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449453
UMLS CUI [1,2]
C1522449
4. life expectancy of greater than or equal to 3 months
Beskrivning

life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
5. eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1
Beskrivning

eastern cooperative oncology group (ecog) performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
6. adequate renal function as evidenced by serum creatinine less than or equal to 1.5 mg/dl or calculated creatinine clearance greater than or equal to 50 ml/minute according to the cockcroft and gault formula
Beskrivning

creatinine

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
7. adequate bone marrow function, defined as:
Beskrivning

bone marrow function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0031843
1. absolute neutrophil count (anc) greater than or equal to 1.5 x 10^9/l
Beskrivning

absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
2. hemoglobin (hb) greater than or equal to 10.0 g/dl (can be corrected by growth factor or transfusion)
Beskrivning

hemoglobin

Datatyp

boolean

Alias
UMLS CUI [1]
C0019046
3. platelet count greater than or equal to 100 x 10^9/l
Beskrivning

platelet count

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
8. adequate liver function, defined as:
Beskrivning

liver function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
1. total bilirubin less than or equal to 1.5 x upper limit of normal (uln)
Beskrivning

total bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C0201913
2. alkaline phosphatase (alp), alanine aminotransferase (alt), and aspartate aminotransferase (ast) less than or equal to 3 x uln unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase
Beskrivning

alkaline phosphatase (alp), alanine aminotransferase (alt), and aspartate aminotransferase (ast)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C0201899
UMLS CUI [1,3]
C0201836
9. resolution of all chemotherapy-related or radiation-related toxicities to grade 1 severity or lower, except for stable sensory neuropathy (less than or equal to grade 2) and alopecia
Beskrivning

chemotherapy-related or radiation-related toxicities

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0600688
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0600688
10. archived tissue sample or new biopsy sample
Beskrivning

tissue or biopsy sample

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0005558
11. females must not be lactating or pregnant at screening or baseline (as documented by a negative beta-human chorionic gonadotropin [b-hcg] (or human chorionic gonadotropin [hcg]) test with a minimum sensitivity of 25 iu/l or equivalent units of b-hcg [or hcg]). a separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
Beskrivning

pregnancy or breast feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
12. all females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy or bilateral oophorectomy, all with surgery at least 1 month before dosing)
Beskrivning

childbearing potential

Datatyp

boolean

Alias
UMLS CUI [1]
C3831118
13. females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, a combination oral contraceptive (estrogen/progesterone), or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 120 days after study drug discontinuation. if currently abstinent, the subject must agree to use a double barrier method as described above if she becomes sexually active during the study period or for 120 days after study drug discontinuation. females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 28 days before dosing and must continue to use the same contraceptive during the study and for 120 days after study drug discontinuation.
Beskrivning

sexual behavior and contraception

Datatyp

boolean

Alias
UMLS CUI [1]
C0036864
UMLS CUI [2]
C0700589
14. males who have had a successful vasectomy (confirmed azoospermia) or they and their female partners meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period or for 120 days after study drug discontinuation). no sperm donation is allowed during the study period or for 120 days after study drug discontinuation.
Beskrivning

vasectomy and sperm donation

Datatyp

boolean

Alias
UMLS CUI [1]
C0042387
UMLS CUI [2,1]
C0871414
UMLS CUI [2,2]
C1518422
15. willing and able to comply with all aspects of the treatment protocol
Beskrivning

protocol compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
16. provide written informed consent
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous treatment with eribulin mesylate or any anti-pd-1, pd-l1, or pd-l2 agent
Beskrivning

eribulin mesylate or any anti-pd-1, pd-l1, or pd-l2 agent

Datatyp

boolean

Alias
UMLS CUI [1]
C2608038
UMLS CUI [2,1]
C1521826
UMLS CUI [2,2]
C0205394
2. autoimmune disease that requires systemic steroids or immunosuppression agents
Beskrivning

autoimmune disease medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0038317
UMLS CUI [2,1]
C0004364
UMLS CUI [2,2]
C0021079
3. less than 6 months since prior adjuvant chemotherapy
Beskrivning

last chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
4. current enrollment in another clinical study or used any investigational drug or device within the past 28 days preceding informed consent
Beskrivning

participation in other studies

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
5. treatment with chemotherapy or biological therapy within the previous 3 weeks, radiation or small molecule targeted therapy within the previous 2 weeks
Beskrivning

chemotherapy, biological therapy or radiation

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0005527
UMLS CUI [3]
C1522449
6. known central nervous system (cns) disease, except for those subjects with treated brain metastasis who are stable for at least 1 month, having no evidence of progression or hemorrhage after treatment and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [mri] or computed tomography [ct]) during the screening period
Beskrivning

central nervous system (cns) disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0007682
7. known history of human immunodeficiency virus (hiv) positive
Beskrivning

hiv

Datatyp

boolean

Alias
UMLS CUI [1]
C0019682
8. known active hepatitis b (eg, hbsag reactive) or hepatitis c (eg, hcv rna detected)
Beskrivning

hepatitis b or c

Datatyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
9. existing anticancer treatment-related toxicities of grades greater than or equal to 2 (except for alopecia and grade 2 sensory neuropathy) according to common terminology criteria for adverse events (ctcae v4.03)
Beskrivning

anticancer treatment-related toxicities

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0600688
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0600688
10. any other malignancy that required treatment or has shown evidence of recurrence (except for nonmelanoma skin cancer, or histologically confirmed complete excision of carcinoma in situ) during the 5 years prior to enrollment in this study
Beskrivning

medical history of cancer and recurrence

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C0034897
11. history of significant cardiovascular disease, defined as:
Beskrivning

cardiovascular disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
1. congestive heart failure greater than new york heart association (nyha) class ii according to the nyha functional classification
Beskrivning

congestive heart failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
2. unstable angina or myocardial infarction within 6 months of enrollment
Beskrivning

unstable angina or myocardial infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
3. serious cardiac arrhythmia
Beskrivning

cardiac arrhythmia

Datatyp

boolean

Alias
UMLS CUI [1]
C0003811
12. clinically significant electrocardiogram (ecg) abnormality, including a marked baseline prolonged qt/qtc ([qt interval/corrected qt interval], eg, a repeated demonstration of a qtc interval greater than 500 ms)
Beskrivning

electrocardiogram (ecg) abnormality, prolonged qt/qtc

Datatyp

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2]
C0151878
13. history of concomitant medical conditions or infectious diseases that, in the opinion of the investigator, would compromise the subject's ability to safely complete the study
Beskrivning

concomitant medical conditions or infectious diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0009450
14. hypersensitivity to the active substance or any other excipients of the eribulin mesylate drug product, or to pembrolizumab
Beskrivning

hypersensitivity to eribulin or pembrolizumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2608038
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C3658706
15. scheduled for surgery during the study, other than minor surgery, which would not delay study treatment
Beskrivning

surgery planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1320712
16. has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. the use of physiologic doses of corticosteroids may be approved after consultation with the sponsor.
Beskrivning

immunodeficiency, systemic steroid therapy or any other form of immunosuppressive therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2]
C0149783
UMLS CUI [3]
C0021079
17. has evidence of active, noninfectious pneumonitis or has a history of pneumonitis that required treatment with steroids
Beskrivning

pneumonitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0264376
UMLS CUI [2,1]
C0032285
UMLS CUI [2,2]
C0149783
18. has a history of interstitial lung disease
Beskrivning

interstitial lung disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0206062
19. has an active infection requiring systemic therapy
Beskrivning

active infection requiring systemic therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1515119
20. has received a live vaccine within 30 days of planned start of study therapy
Beskrivning

administration of live vaccine

Datatyp

boolean

Alias
UMLS CUI [1]
C2368628
21. the investigator's belief that the subject is medically unfit to receive eribulin mesylate and pembrolizumab or unsuitable for any other reason
Beskrivning

medical condition for participation

Datatyp

boolean

Alias
UMLS CUI [1]
C3843040
UMLS CUI [2]
C0443343
UMLS CUI [3]
C2348568
Tillbaka till toppen

Similar models

Eligibility Breast Cancer NCT02513472

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
1. females or males, aged greater than or equal to 18 years at the time of signing the informed consent form (icf)
boolean
C0001779 (UMLS CUI [1])
triple negative breast cancer chemotherapy
Item
2. metastatic triple-negative, ie, estrogen receptor (er) negative/ progesterone receptor negative / human epidermal growth factor receptor 2 (her2) -negative (defined as immunohistochemistry [ihc] less than 2+ or fluorescence in situ hybridization [fish] negative) breast cancer previously treated with 0 to 2 lines of chemotherapy in the metastatic setting
boolean
C2348819 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
criteria for measurable disease
Item
3. presence of measurable disease meeting the following criteria:
boolean
C1513041 (UMLS CUI [1])
lymph node or nonlymph node lesion
Item
1. at least 1 lesion of greater than or equal to 10 mm in long axis diameter for nonlymph nodes or greater than or equal to 15 mm in short axis diameter for lymph nodes that is serially measurable according to recist 1.1 using computerized tomography or magnetic resonance imaging or panoramic and close-up color photography
boolean
C0024204 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0040300 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0221198 (UMLS CUI [2,3])
lesion size after radiotherapy
Item
2. lesions that have had radiotherapy must show subsequent radiographic evidence of increased size to be deemed a target lesion
boolean
C0449453 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
life expectancy
Item
4. life expectancy of greater than or equal to 3 months
boolean
C0023671 (UMLS CUI [1])
eastern cooperative oncology group (ecog) performance status
Item
5. eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1
boolean
C1520224 (UMLS CUI [1])
creatinine
Item
6. adequate renal function as evidenced by serum creatinine less than or equal to 1.5 mg/dl or calculated creatinine clearance greater than or equal to 50 ml/minute according to the cockcroft and gault formula
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
bone marrow function
Item
7. adequate bone marrow function, defined as:
boolean
C0678852 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0031843 (UMLS CUI [1,3])
absolute neutrophil count
Item
1. absolute neutrophil count (anc) greater than or equal to 1.5 x 10^9/l
boolean
C0948762 (UMLS CUI [1])
hemoglobin
Item
2. hemoglobin (hb) greater than or equal to 10.0 g/dl (can be corrected by growth factor or transfusion)
boolean
C0019046 (UMLS CUI [1])
platelet count
Item
3. platelet count greater than or equal to 100 x 10^9/l
boolean
C0032181 (UMLS CUI [1])
liver function
Item
8. adequate liver function, defined as:
boolean
C0232741 (UMLS CUI [1])
total bilirubin
Item
1. total bilirubin less than or equal to 1.5 x upper limit of normal (uln)
boolean
C0201913 (UMLS CUI [1])
alkaline phosphatase (alp), alanine aminotransferase (alt), and aspartate aminotransferase (ast)
Item
2. alkaline phosphatase (alp), alanine aminotransferase (alt), and aspartate aminotransferase (ast) less than or equal to 3 x uln unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase
boolean
C0201850 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
C0201836 (UMLS CUI [1,3])
chemotherapy-related or radiation-related toxicities
Item
9. resolution of all chemotherapy-related or radiation-related toxicities to grade 1 severity or lower, except for stable sensory neuropathy (less than or equal to grade 2) and alopecia
boolean
C0392920 (UMLS CUI [1,1])
C0600688 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0600688 (UMLS CUI [2,2])
tissue or biopsy sample
Item
10. archived tissue sample or new biopsy sample
boolean
C0475358 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
pregnancy or breast feeding
Item
11. females must not be lactating or pregnant at screening or baseline (as documented by a negative beta-human chorionic gonadotropin [b-hcg] (or human chorionic gonadotropin [hcg]) test with a minimum sensitivity of 25 iu/l or equivalent units of b-hcg [or hcg]). a separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
childbearing potential
Item
12. all females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy or bilateral oophorectomy, all with surgery at least 1 month before dosing)
boolean
C3831118 (UMLS CUI [1])
sexual behavior and contraception
Item
13. females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, a combination oral contraceptive (estrogen/progesterone), or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 120 days after study drug discontinuation. if currently abstinent, the subject must agree to use a double barrier method as described above if she becomes sexually active during the study period or for 120 days after study drug discontinuation. females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 28 days before dosing and must continue to use the same contraceptive during the study and for 120 days after study drug discontinuation.
boolean
C0036864 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
vasectomy and sperm donation
Item
14. males who have had a successful vasectomy (confirmed azoospermia) or they and their female partners meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period or for 120 days after study drug discontinuation). no sperm donation is allowed during the study period or for 120 days after study drug discontinuation.
boolean
C0042387 (UMLS CUI [1])
C0871414 (UMLS CUI [2,1])
C1518422 (UMLS CUI [2,2])
protocol compliance
Item
15. willing and able to comply with all aspects of the treatment protocol
boolean
C0525058 (UMLS CUI [1])
informed consent
Item
16. provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
eribulin mesylate or any anti-pd-1, pd-l1, or pd-l2 agent
Item
1. previous treatment with eribulin mesylate or any anti-pd-1, pd-l1, or pd-l2 agent
boolean
C2608038 (UMLS CUI [1])
C1521826 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
autoimmune disease medication
Item
2. autoimmune disease that requires systemic steroids or immunosuppression agents
boolean
C0004364 (UMLS CUI [1,1])
C0038317 (UMLS CUI [1,2])
C0004364 (UMLS CUI [2,1])
C0021079 (UMLS CUI [2,2])
last chemotherapy
Item
3. less than 6 months since prior adjuvant chemotherapy
boolean
C0392920 (UMLS CUI [1])
participation in other studies
Item
4. current enrollment in another clinical study or used any investigational drug or device within the past 28 days preceding informed consent
boolean
C2348568 (UMLS CUI [1])
chemotherapy, biological therapy or radiation
Item
5. treatment with chemotherapy or biological therapy within the previous 3 weeks, radiation or small molecule targeted therapy within the previous 2 weeks
boolean
C0392920 (UMLS CUI [1])
C0005527 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
central nervous system (cns) disease
Item
6. known central nervous system (cns) disease, except for those subjects with treated brain metastasis who are stable for at least 1 month, having no evidence of progression or hemorrhage after treatment and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [mri] or computed tomography [ct]) during the screening period
boolean
C0007682 (UMLS CUI [1])
hiv
Item
7. known history of human immunodeficiency virus (hiv) positive
boolean
C0019682 (UMLS CUI [1])
hepatitis b or c
Item
8. known active hepatitis b (eg, hbsag reactive) or hepatitis c (eg, hcv rna detected)
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
anticancer treatment-related toxicities
Item
9. existing anticancer treatment-related toxicities of grades greater than or equal to 2 (except for alopecia and grade 2 sensory neuropathy) according to common terminology criteria for adverse events (ctcae v4.03)
boolean
C0392920 (UMLS CUI [1,1])
C0600688 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0600688 (UMLS CUI [2,2])
medical history of cancer and recurrence
Item
10. any other malignancy that required treatment or has shown evidence of recurrence (except for nonmelanoma skin cancer, or histologically confirmed complete excision of carcinoma in situ) during the 5 years prior to enrollment in this study
boolean
C0262926 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,3])
cardiovascular disease
Item
11. history of significant cardiovascular disease, defined as:
boolean
C0007222 (UMLS CUI [1])
congestive heart failure
Item
1. congestive heart failure greater than new york heart association (nyha) class ii according to the nyha functional classification
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
unstable angina or myocardial infarction
Item
2. unstable angina or myocardial infarction within 6 months of enrollment
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
cardiac arrhythmia
Item
3. serious cardiac arrhythmia
boolean
C0003811 (UMLS CUI [1])
electrocardiogram (ecg) abnormality, prolonged qt/qtc
Item
12. clinically significant electrocardiogram (ecg) abnormality, including a marked baseline prolonged qt/qtc ([qt interval/corrected qt interval], eg, a repeated demonstration of a qtc interval greater than 500 ms)
boolean
C0522055 (UMLS CUI [1])
C0151878 (UMLS CUI [2])
concomitant medical conditions or infectious diseases
Item
13. history of concomitant medical conditions or infectious diseases that, in the opinion of the investigator, would compromise the subject's ability to safely complete the study
boolean
C0262926 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
hypersensitivity to eribulin or pembrolizumab
Item
14. hypersensitivity to the active substance or any other excipients of the eribulin mesylate drug product, or to pembrolizumab
boolean
C0020517 (UMLS CUI [1,1])
C2608038 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C3658706 (UMLS CUI [2,2])
surgery planned
Item
15. scheduled for surgery during the study, other than minor surgery, which would not delay study treatment
boolean
C0543467 (UMLS CUI [1,1])
C1320712 (UMLS CUI [1,2])
immunodeficiency, systemic steroid therapy or any other form of immunosuppressive therapy
Item
16. has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. the use of physiologic doses of corticosteroids may be approved after consultation with the sponsor.
boolean
C0021051 (UMLS CUI [1])
C0149783 (UMLS CUI [2])
C0021079 (UMLS CUI [3])
pneumonitis
Item
17. has evidence of active, noninfectious pneumonitis or has a history of pneumonitis that required treatment with steroids
boolean
C0264376 (UMLS CUI [1])
C0032285 (UMLS CUI [2,1])
C0149783 (UMLS CUI [2,2])
interstitial lung disease
Item
18. has a history of interstitial lung disease
boolean
C0206062 (UMLS CUI [1])
active infection requiring systemic therapy
Item
19. has an active infection requiring systemic therapy
boolean
C0009450 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
administration of live vaccine
Item
20. has received a live vaccine within 30 days of planned start of study therapy
boolean
C2368628 (UMLS CUI [1])
medical condition for participation
Item
21. the investigator's belief that the subject is medically unfit to receive eribulin mesylate and pembrolizumab or unsuitable for any other reason
boolean
C3843040 (UMLS CUI [1])
C0443343 (UMLS CUI [2])
C2348568 (UMLS CUI [3])
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