Urothelial carcinoma untreated | Operative Surgical Procedure Required
Item
previously untreated urothelial cancer requiring surgery for treatment
boolean
C0007138 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Ineligibility Chemotherapy
Item
ineligible for chemotherapy
boolean
C1512714 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Hematologic function | Renal function | Liver function
Item
adequate hematologic, kidney and liver function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Females & males of reproductive potential Sexually active Contraceptive methods Unwilling | Females & males of reproductive potential Sexually active Contraceptive methods Unable | Partner Contraceptive methods Unwilling | Partner Contraceptive methods Unable
Item
sexually active and fertile individuals or partners of these individuals who are unwilling or unable to use an acceptable method of birth control for the entire trial and up to 4 weeks after the study
boolean
C4034483 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0558080 (UMLS CUI [1,4])
C4034483 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
C0682323 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C0682323 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C1299582 (UMLS CUI [4,3])
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pregnancy test positive
Item
women with a positive pregnancy test on enrollment prior to study drug administration
boolean
C0240802 (UMLS CUI [1])
Ipilimumab | Anti-CTLA-4 Monoclonal Antibody | CD137 Agonist
Item
prior treatment with ipilimumab or other anti-ctla4 antibody, or a cd137 agonist
boolean
C1367202 (UMLS CUI [1])
C4289973 (UMLS CUI [2])
C0214721 (UMLS CUI [3,1])
C2987634 (UMLS CUI [3,2])
Cancer Other | Exception Basal cell carcinoma Treated Cured | Exception Squamous cell carcinoma of skin Treated Cured | Exception Carcinoma in situ of uterine cervix | Exception Disease Free of
Item
concurrent malignancy, with the exception of adequately treated and cured basal or squamous cell skin cancer, or carcinoma in situ of the cervix (previous malignancy without evidence of disease for 5 years will also be allowed to enter trial)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1880198 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1880198 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
Autoimmune Disease | Inflammatory Bowel Disease | Crohn Disease | Ulcerative Colitis | Disease Symptomatic | Rheumatoid Arthritis | Systemic Scleroderma | Lupus Erythematosus, Systemic | Autoimmune vasculitis | Granulomatosis with polyangiitis | Guillain-Barre Syndrome
Item
autoimmune disease: subjects with a documented history of inflammatory bowel disease (including crohn's disease and ulcerative colitis) are excluded from this study as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., wegener's granulomatosis]). subjects with motor neuropathy considered of autoimmune origin (e.g., guillain-barre syndrome) are excluded from this study
boolean
C0004364 (UMLS CUI [1])
C0021390 (UMLS CUI [2])
C0010346 (UMLS CUI [3])
C0009324 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0231220 (UMLS CUI [5,2])
C0003873 (UMLS CUI [6])
C0036421 (UMLS CUI [7])
C0024141 (UMLS CUI [8])
C1328843 (UMLS CUI [9])
C3495801 (UMLS CUI [10])
C0018378 (UMLS CUI [11])
Ineligibility Operative Surgical Procedures
Item
patients deemed ineligible for surgery
boolean
C1512714 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Vaccine Therapy Prevention Communicable Disease
Item
any non-oncology vaccine therapy used for prevention of infectious diseased in the past month
boolean
C0042209 (UMLS CUI [1,1])
C0199176 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
IL-2 | Interferon | Immunotherapy | Chemotherapy | Immunosuppressive Agents | Therapies, Investigational | CORTICOSTEROIDS FOR SYSTEMIC USE chronic
Item
concomitant therapy with any of the following: il-2, interferon or other non-study immunotherapy regimens, chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer related illnesses)
boolean
C0021756 (UMLS CUI [1])
C3652465 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C0021081 (UMLS CUI [5])
C0949266 (UMLS CUI [6])
C3653708 (UMLS CUI [7,1])
C0205191 (UMLS CUI [7,2])
Prior radiation therapy Urothelial carcinoma
Item
prior radiation therapy for urothelial cancer
boolean
C0279134 (UMLS CUI [1,1])
C0007138 (UMLS CUI [1,2])
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Item
positive screening tests for or any prior history of hiv, hepatitis b or hepatitis c
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])