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])
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])