ID

35892

Description

Study of MK-3475 (Pembrolizumab) in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma After Treatment With Platinum-based and Cetuximab Therapy (MK-3475-055/KEYNOTE-055); ODM derived from: https://clinicaltrials.gov/show/NCT02255097

Link

https://clinicaltrials.gov/show/NCT02255097

Keywords

Versions (1)
  1. 4/2/19 4/2/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 2, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Head and Neck Squamous Cell Carcinoma (HNSCC) NCT02255097

English

Eligibility Head and Neck Squamous Cell Carcinoma (HNSCC) NCT02255097

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically- or cytologically-confirmed recurrent or metastatic hnscc of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies
Description

Recurrent Head and Neck Squamous Cell Carcinoma Oral cavity | Squamous cell carcinoma of the head and neck metastatic Oral cavity | Recurrent Head and Neck Squamous Cell Carcinoma Oropharynx | Squamous cell carcinoma of the head and neck metastatic Oropharynx | Recurrent Head and Neck Squamous Cell Carcinoma Hypopharynx | Squamous cell carcinoma of the head and neck metastatic Hypopharynx | Recurrent Head and Neck Squamous Cell Carcinoma Larynx | Squamous cell carcinoma of the head and neck metastatic Larynx | Local Therapy Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C4524839
UMLS CUI [1,2]
C0226896
UMLS CUI [2,1]
C1168401
UMLS CUI [2,2]
C1522484
UMLS CUI [2,3]
C0226896
UMLS CUI [3,1]
C4524839
UMLS CUI [3,2]
C0521367
UMLS CUI [4,1]
C1168401
UMLS CUI [4,2]
C1522484
UMLS CUI [4,3]
C0521367
UMLS CUI [5,1]
C4524839
UMLS CUI [5,2]
C0020629
UMLS CUI [6,1]
C1168401
UMLS CUI [6,2]
C1522484
UMLS CUI [6,3]
C0020629
UMLS CUI [7,1]
C4524839
UMLS CUI [7,2]
C0023078
UMLS CUI [8,1]
C1168401
UMLS CUI [8,2]
C1522484
UMLS CUI [8,3]
C0023078
UMLS CUI [9,1]
C1517925
UMLS CUI [9,2]
C1272705
tumor progression or recurrence within 6 months of the last dose of any number of platinum-based and cetuximab therapy lines in the adjuvant, primary, recurrent, or metastatic setting; must be resistant (not responding) to both platinum and cetuximab
Description

Tumor Progression | Recurrent tumor | Therapeutic procedure Platinum-Based | cetuximab | Adjuvant therapy | Primary tumor | Recurrent disease | Neoplasm Metastasis | Refractory cancer

Data type

boolean

Alias
UMLS CUI [1]
C0178874
UMLS CUI [2]
C0521158
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1514162
UMLS CUI [4]
C0995188
UMLS CUI [5]
C0677850
UMLS CUI [6]
C0677930
UMLS CUI [7]
C0277556
UMLS CUI [8]
C0027627
UMLS CUI [9]
C0677936
available tissue for biomarker analysis
Description

Availability of Tissue Biomarker Analysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0040300
UMLS CUI [1,3]
C1879847
measurable disease based on recist 1.1 as determined by central review
Description

Measurable Disease

Data type

boolean

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

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ function
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
female participants of childbearing potential must have a negative urine or serum pregnancy test and must be willing to use 2 adequate methods of contraception starting with the screening visit through 120 days after the last dose of pembrolizumab
Description

Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods Quantity | pembrolizumab

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430061
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1265611
UMLS CUI [4]
C3658706
male participants with a female partner(s) of childbearing potential must be willing to use 2 adequate methods of contraception from screening through 120 days after the last dose of pembrolizumab
Description

Gender Partner Childbearing Potential Contraceptive methods | pembrolizumab

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C3831118
UMLS CUI [1,4]
C0700589
UMLS CUI [2]
C3658706
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
disease that is suitable for local therapy administered with curative intent
Description

Disease Suitable Local Therapy Curative

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C1517925
UMLS CUI [1,4]
C1276305
currently receiving treatment in a study of an investigational agent or using an investigational device <= 4 weeks prior to the first dose of trial medication
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial medication
Description

Immunodeficiency | Steroid therapy Systemic | Therapeutic immunosuppression

Data type

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2,1]
C0149783
UMLS CUI [2,2]
C0205373
UMLS CUI [3]
C0021079
not recovered from aes due to a previously administered therapy
Description

Adverse event Due to Prior Therapy | Recovery Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C2004454
UMLS CUI [2,2]
C0332268
known additional malignancy that is progressing or requires active treatment excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cancer
Description

Cancer Other Progressing | Cancer Other Treatment required for | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Carcinoma in Situ

Data type

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0205329
UMLS CUI [2,1]
C1707251
UMLS CUI [2,2]
C0332121
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0553723
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0007099
known active central nervous system (cns) metastases and/or carcinomatous meningitis
Description

CNS metastases | Meningeal Carcinomatosis

Data type

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0220654
active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
Description

Autoimmune Disease Requirement Systemic therapy | Autoimmune Disease Severe | Syndrome Requirement Systemic steroids | Syndrome Requirement Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1515119
UMLS CUI [2,1]
C0004364
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0039082
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C2825233
UMLS CUI [4,1]
C0039082
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0021081
active, non-infectious pneumonitis
Description

Pneumonitis | Communicable Disease Absent

Data type

boolean

Alias
UMLS CUI [1]
C3714636
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0332197
active infection requiring systemic therapy
Description

Communicable Disease Requirement Systemic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1515119
pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial medication
Description

Pregnancy | Breast Feeding | Pregnancy Expected | Conception Expected

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1517001
UMLS CUI [4,1]
C0009637
UMLS CUI [4,2]
C1517001
human immunodeficiency virus (hiv)
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
hepatitis b or c
Description

Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
received live vaccine within 30 days of planned start of study therapy
Description

Vaccines, Attenuated

Data type

boolean

Alias
UMLS CUI [1]
C0042211
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Similar models

Eligibility Head and Neck Squamous Cell Carcinoma (HNSCC) NCT02255097

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Recurrent Head and Neck Squamous Cell Carcinoma Oral cavity | Squamous cell carcinoma of the head and neck metastatic Oral cavity | Recurrent Head and Neck Squamous Cell Carcinoma Oropharynx | Squamous cell carcinoma of the head and neck metastatic Oropharynx | Recurrent Head and Neck Squamous Cell Carcinoma Hypopharynx | Squamous cell carcinoma of the head and neck metastatic Hypopharynx | Recurrent Head and Neck Squamous Cell Carcinoma Larynx | Squamous cell carcinoma of the head and neck metastatic Larynx | Local Therapy Unsuccessful
Item
histologically- or cytologically-confirmed recurrent or metastatic hnscc of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies
boolean
C4524839 (UMLS CUI [1,1])
C0226896 (UMLS CUI [1,2])
C1168401 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C0226896 (UMLS CUI [2,3])
C4524839 (UMLS CUI [3,1])
C0521367 (UMLS CUI [3,2])
C1168401 (UMLS CUI [4,1])
C1522484 (UMLS CUI [4,2])
C0521367 (UMLS CUI [4,3])
C4524839 (UMLS CUI [5,1])
C0020629 (UMLS CUI [5,2])
C1168401 (UMLS CUI [6,1])
C1522484 (UMLS CUI [6,2])
C0020629 (UMLS CUI [6,3])
C4524839 (UMLS CUI [7,1])
C0023078 (UMLS CUI [7,2])
C1168401 (UMLS CUI [8,1])
C1522484 (UMLS CUI [8,2])
C0023078 (UMLS CUI [8,3])
C1517925 (UMLS CUI [9,1])
C1272705 (UMLS CUI [9,2])
Tumor Progression | Recurrent tumor | Therapeutic procedure Platinum-Based | cetuximab | Adjuvant therapy | Primary tumor | Recurrent disease | Neoplasm Metastasis | Refractory cancer
Item
tumor progression or recurrence within 6 months of the last dose of any number of platinum-based and cetuximab therapy lines in the adjuvant, primary, recurrent, or metastatic setting; must be resistant (not responding) to both platinum and cetuximab
boolean
C0178874 (UMLS CUI [1])
C0521158 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C1514162 (UMLS CUI [3,2])
C0995188 (UMLS CUI [4])
C0677850 (UMLS CUI [5])
C0677930 (UMLS CUI [6])
C0277556 (UMLS CUI [7])
C0027627 (UMLS CUI [8])
C0677936 (UMLS CUI [9])
Availability of Tissue Biomarker Analysis
Item
available tissue for biomarker analysis
boolean
C0470187 (UMLS CUI [1,1])
C0040300 (UMLS CUI [1,2])
C1879847 (UMLS CUI [1,3])
Measurable Disease
Item
measurable disease based on recist 1.1 as determined by central review
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
adequate organ function
boolean
C0678852 (UMLS CUI [1])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods Quantity | pembrolizumab
Item
female participants of childbearing potential must have a negative urine or serum pregnancy test and must be willing to use 2 adequate methods of contraception starting with the screening visit through 120 days after the last dose of pembrolizumab
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C3658706 (UMLS CUI [4])
Gender Partner Childbearing Potential Contraceptive methods | pembrolizumab
Item
male participants with a female partner(s) of childbearing potential must be willing to use 2 adequate methods of contraception from screening through 120 days after the last dose of pembrolizumab
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C3831118 (UMLS CUI [1,3])
C0700589 (UMLS CUI [1,4])
C3658706 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Disease Suitable Local Therapy Curative
Item
disease that is suitable for local therapy administered with curative intent
boolean
C0012634 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C1517925 (UMLS CUI [1,3])
C1276305 (UMLS CUI [1,4])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
currently receiving treatment in a study of an investigational agent or using an investigational device <= 4 weeks prior to the first dose of trial medication
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Immunodeficiency | Steroid therapy Systemic | Therapeutic immunosuppression
Item
diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial medication
boolean
C0021051 (UMLS CUI [1])
C0149783 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0021079 (UMLS CUI [3])
Adverse event Due to Prior Therapy | Recovery Lacking
Item
not recovered from aes due to a previously administered therapy
boolean
C0877248 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C2004454 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Cancer Other Progressing | Cancer Other Treatment required for | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Carcinoma in Situ
Item
known additional malignancy that is progressing or requires active treatment excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cancer
boolean
C1707251 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C1707251 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0007117 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0553723 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0007099 (UMLS CUI [5,2])
CNS metastases | Meningeal Carcinomatosis
Item
known active central nervous system (cns) metastases and/or carcinomatous meningitis
boolean
C0686377 (UMLS CUI [1])
C0220654 (UMLS CUI [2])
Autoimmune Disease Requirement Systemic therapy | Autoimmune Disease Severe | Syndrome Requirement Systemic steroids | Syndrome Requirement Immunosuppressive Agents
Item
active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
boolean
C0004364 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
C0004364 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0039082 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C2825233 (UMLS CUI [3,3])
C0039082 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0021081 (UMLS CUI [4,3])
Pneumonitis | Communicable Disease Absent
Item
active, non-infectious pneumonitis
boolean
C3714636 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Communicable Disease Requirement Systemic therapy
Item
active infection requiring systemic therapy
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Pregnancy Expected | Conception Expected
Item
pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial medication
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
C0009637 (UMLS CUI [4,1])
C1517001 (UMLS CUI [4,2])
HIV Infection
Item
human immunodeficiency virus (hiv)
boolean
C0019693 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
hepatitis b or c
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Vaccines, Attenuated
Item
received live vaccine within 30 days of planned start of study therapy
boolean
C0042211 (UMLS CUI [1])
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