Recurrent Head and Neck Squamous Cell Carcinoma Locoregional Inoperable | Squamous cell carcinoma of the head and neck Second Primary | Oral cavity | Oropharynx | Larynx | Hypopharynx
Item
locoregional inoperable recurrent or second primary squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx)
boolean
C4524839 (UMLS CUI [1,1])
C1947913 (UMLS CUI [1,2])
C0205187 (UMLS CUI [1,3])
C1168401 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
C0205225 (UMLS CUI [2,3])
C0226896 (UMLS CUI [3])
C0521367 (UMLS CUI [4])
C0023078 (UMLS CUI [5])
C0020629 (UMLS CUI [6])
Prior radiation therapy Curative Quantity
Item
have had only one prior course of radiation therapy with a curative intent and it has been at least 6 months since completion of radiation
boolean
C0279134 (UMLS CUI [1,1])
C1276305 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Prior radiation therapy Dose Tumor Volume Percentage | Therapeutic radiology procedure Limited Spinal Cord
Item
based on prior radiation records, have had most of the tumor volume (>50%) previously radiated at doses > 45 gy without exceeding spinal cord tolerance (combining previous and future radiation dose to spinal cord of < 50 gy).
boolean
C0279134 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0475276 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
C1522449 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0037925 (UMLS CUI [2,3])
Percutaneous endoscopic gastrostomy
Item
be willing to undergo percutaneous endoscopic gastrostomy (peg) placement, if necessary.
boolean
C0176751 (UMLS CUI [1])
Measurable Disease Within Radiation Field
Item
have at least one measurable area of disease based on recist 1.1 within the previously radiated field.
boolean
C1513041 (UMLS CUI [1,1])
C0332285 (UMLS CUI [1,2])
C1882536 (UMLS CUI [1,3])
Tissue specimen PD-L1 Analysis
Item
have provided adequate tissue for pd-l1 analysis either from an archival tissue sample or fresh biopsy done to confirm recurrence/second primary. archival tissue sample can only be used if done within 3 months of enrollment on the clinical trial.
boolean
C1292533 (UMLS CUI [1,1])
C0965245 (UMLS CUI [1,2])
C0002778 (UMLS CUI [1,3])
ECOG performance status
Item
performance status of 0 or 1 on the ecog performance scale.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy greater than 12 weeks
boolean
C0023671 (UMLS CUI [1])
Organ function Laboratory Results
Item
adequate organ function based on laboratory results
boolean
C0678852 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
Distant metastasis
Item
presence of distant metastatic disease.
boolean
C1269798 (UMLS CUI [1])
Immunodeficiency | Steroid therapy Systemic | Therapeutic immunosuppression
Item
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.
boolean
C0021051 (UMLS CUI [1])
C0149783 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0021079 (UMLS CUI [3])
Cancer Other | Exception Squamous cell carcinoma of the head and neck | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Cervix carcinoma
Item
| C1705847 history of other malignancy within 5 years with the exception of prior squamous cell carcinoma of the head and neck, adequately treated basal cell or squamous cell skin cancer, or carcinoma of the cervix.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1168401 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0302592 (UMLS CUI [5,2])
Autoimmune Disease
Item
has an active autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Lung Diseases, Interstitial | Non-infectious pneumonia
Item
has evidence of interstitial lung disease or active, non-infectious pneumonitis.
boolean
C0206062 (UMLS CUI [1])
C0264376 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
is pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Prior Therapy | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | PD-L2 Monoclonal Antibodies | CD137 Monoclonal Antibodies | Anti-CTLA-4 Monoclonal Antibody | ipilimumab | Antibodies Targeting T-Lymphocyte | Pharmaceutical Preparations Targeting T-Lymphocyte
Item
has received prior therapy with an anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or anti-cytotoxic t-lymphocyte-associated antigen-4 (ctla-4) antibody (including ipilimumab or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways).
boolean
C1514463 (UMLS CUI [1])
C4289970 (UMLS CUI [2])
C4289971 (UMLS CUI [3])
C1705357 (UMLS CUI [4,1])
C0003250 (UMLS CUI [4,2])
C0214721 (UMLS CUI [5,1])
C0003250 (UMLS CUI [5,2])
C4289973 (UMLS CUI [6])
C1367202 (UMLS CUI [7])
C0003241 (UMLS CUI [8,1])
C1521840 (UMLS CUI [8,2])
C0039194 (UMLS CUI [8,3])
C0013227 (UMLS CUI [9,1])
C1521840 (UMLS CUI [9,2])
C0039194 (UMLS CUI [9,3])
HIV Infection | HIV-1 Antibody Measurement | HIV-2 Antibody Measurement
Item
has a known history of human immunodeficiency virus (hiv) (hiv 1/2 antibodies).
boolean
C0019693 (UMLS CUI [1])
C0373916 (UMLS CUI [2])
C0373917 (UMLS CUI [3])
Hepatitis B | Hepatitis B surface antigen positive | Hepatitis C | Hepatitis C virus RNA Detected
Item
has known active hepatitis b (e.g., hbsag reactive) or hepatitis c (e.g., hcv rna [qualitative] is detected).
boolean
C0019163 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0369335 (UMLS CUI [4,1])
C0442726 (UMLS CUI [4,2])
Vaccines, Attenuated
Item
has received a live vaccine within 30 days prior to the first dose of trial treatment
boolean
C0042211 (UMLS CUI [1])