Clear Cell Renal Cell Carcinoma predominant
Item
1. histologically confirmed diagnosis of predominant clear cell renal cell carcinoma.
boolean
C0279702 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Neoplasm Metastasis Advanced
Item
2. advanced metastatic disease
boolean
C0027627 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Progressive Disease
Item
3. documented progressive disease based on radiographic, clinical or pathologic assessment during or subsequent to last therapy.
boolean
C1335499 (UMLS CUI [1])
Cancer treatment Quantity | Count Independent of Interleukin-2 | Count Independent of Interferon
Item
4. for phase l, no more than 3 prior anticancer regimens and for phase ll, no more than 1 prior anticancer regimen (il-2 or interferon do not count towards the total).
boolean
C0920425 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0750480 (UMLS CUI [2,1])
C0332291 (UMLS CUI [2,2])
C0021756 (UMLS CUI [2,3])
C0750480 (UMLS CUI [3,1])
C0332291 (UMLS CUI [3,2])
C3652465 (UMLS CUI [3,3])
Measurable Disease
Item
5. measurable (target) disease.
boolean
C1513041 (UMLS CUI [1])
Life Expectancy
Item
6. life expectancy ≥ 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Females & males of reproductive potential Contraceptive methods
Item
7. if of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 70 days following last treatment dose.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Availability of Tumor tissue sample | Consent Biopsy
Item
8. must have available tumor tissue and consent to biopsy while on study.
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C1511481 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
CD27 Antibody
Item
1. prior therapy with an anti-cd27 antibody.
boolean
C0054949 (UMLS CUI [1,1])
C0003241 (UMLS CUI [1,2])
Prior Therapy Sunitinib
Item
2. previous treatment with sunitinib.
boolean
C1514463 (UMLS CUI [1,1])
C1176020 (UMLS CUI [1,2])
Immunotherapy Investigational
Item
3. use of any experimental immunotherapy.
boolean
C0021083 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
Chemotherapy
Item
4. chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to the planned start of study treatment.
boolean
C0392920 (UMLS CUI [1])
Systemic Radiation Therapy | Therapeutic radiology procedure Focal | Radiopharmaceuticals | Strontium | Samarium
Item
5. systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or radiopharmaceuticals (strontium, samarium) within 8 weeks prior to the first dose of study treatment.
boolean
C2985381 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0205234 (UMLS CUI [2,2])
C0182638 (UMLS CUI [3])
C0038467 (UMLS CUI [4])
C0036147 (UMLS CUI [5])
Immunosuppressive Agents | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
6. use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to first dose of study treatment.
boolean
C0021081 (UMLS CUI [1])
C3653708 (UMLS CUI [2])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in Situ Treated | Exception Disease Free Duration
Item
7. other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 3 years.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007099 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
CNS metastases Untreated
Item
8. active, untreated central nervous system metastases.
boolean
C0686377 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Autoimmune Disease
Item
9. active autoimmune disease or a documented history of autoimmune disease.
boolean
C0004364 (UMLS CUI [1])
Diverticulitis
Item
10. active diverticulitis.
boolean
C0012813 (UMLS CUI [1])
Cardiovascular Disease | Congestive heart failure | Poor hypertension control
Item
11. significant cardiovascular disease including chf or poorly controlled hypertension.
boolean
C0007222 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C0421190 (UMLS CUI [3])
Impaired gastrointestinal system function | Gastrointestinal Disease Changing Absorption Sunitinib
Item
12. impairment of gastrointestinal function or gastrointestinal disease that may alter the absorption of sunitinib.
boolean
C0232459 (UMLS CUI [1])
C0017178 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C1176020 (UMLS CUI [2,4])