Melanoma Advanced Locally unresectable | Metastatic melanoma unresectable | Squamous cell carcinoma of the head and neck | Squamous non-small cell lung cancer CD276 gene Expression
Item
histologically-proven, unresectable, locally advanced or metastatic melanoma, scchn, or squamous cell nsclc that express b7-h3.
boolean
C0025202 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C1519810 (UMLS CUI [1,4])
C0278883 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C1168401 (UMLS CUI [3])
C4509816 (UMLS CUI [4,1])
C1540293 (UMLS CUI [4,2])
C0017262 (UMLS CUI [4,3])
Melanoma Progressive | Systemic therapy Quantity | Advanced disease Locally unresectable | Neoplasm Metastasis unresectable | Intolerance First line treatment Melanoma | Refusal of First line treatment Melanoma | Biopsy Required
Item
melanoma that has progressed during or following at least 1 and up to 5 prior systemic treatments for unresectable locally advanced or metastatic disease, or melanoma patients who are intolerable of or have refused standard first line cancer therapy. pre- and on-study biopsy required.
boolean
C0025202 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0679246 (UMLS CUI [3,1])
C1517927 (UMLS CUI [3,2])
C1519810 (UMLS CUI [3,3])
C0027627 (UMLS CUI [4,1])
C1519810 (UMLS CUI [4,2])
C0231199 (UMLS CUI [5,1])
C1708063 (UMLS CUI [5,2])
C0025202 (UMLS CUI [5,3])
C0040809 (UMLS CUI [6,1])
C1708063 (UMLS CUI [6,2])
C0025202 (UMLS CUI [6,3])
C0005558 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
Squamous cell carcinoma of the head and neck Progressive | Systemic therapy Quantity | Neoplasm Metastasis incurable | Recurrent disease incurable | Radical excision Refused Recurrent disease | Intolerance First line treatment | First line treatment Refused
Item
scchn that has progressed during or following at least 1 and up to 5 prior systemic treatments for metastatic or recurrent disease deemed to be incurable. patient who refuse radical resection for recurrent disease or are intolerant of or refused standard first line therapy are eligible to enroll
boolean
C1168401 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0175969 (UMLS CUI [3,2])
C0277556 (UMLS CUI [4,1])
C0175969 (UMLS CUI [4,2])
C0184918 (UMLS CUI [5,1])
C1705116 (UMLS CUI [5,2])
C0277556 (UMLS CUI [5,3])
C0231199 (UMLS CUI [6,1])
C1708063 (UMLS CUI [6,2])
C1708063 (UMLS CUI [7,1])
C1705116 (UMLS CUI [7,2])
Squamous non-small cell lung cancer Progressive | Systemic therapy Quantity | Advanced disease Locally unresectable | Neoplasm Metastasis unresectable | docetaxel | gemcitabine | Platinum Analogue | Intolerance First line treatment | First line treatment Refused
Item
squamous cell nsclc that has progressed during or following 1 - 5 prior systemic therapies for unresectable locally advanced or metastatic disease (at least one docetaxel, gemcitabine, or platinum analogue based therapy), or are intolerant of or refused standard first line cancer therapy.
boolean
C4509816 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0679246 (UMLS CUI [3,1])
C1517927 (UMLS CUI [3,2])
C1519810 (UMLS CUI [3,3])
C0027627 (UMLS CUI [4,1])
C1519810 (UMLS CUI [4,2])
C0246415 (UMLS CUI [5])
C0045093 (UMLS CUI [6])
C0032207 (UMLS CUI [7,1])
C0243071 (UMLS CUI [7,2])
C0231199 (UMLS CUI [8,1])
C1708063 (UMLS CUI [8,2])
C1708063 (UMLS CUI [9,1])
C1705116 (UMLS CUI [9,2])
Measurable Disease
Item
measurable disease per recist 1.1 criteria
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
easter cooperative oncology group (ecog) performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Laboratory Results Acceptable | Organ function Mass
Item
acceptable laboratory parameters and adequate organ reserve.
boolean
C1254595 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C0678852 (UMLS CUI [2,1])
C1306372 (UMLS CUI [2,2])
CNS metastases Symptomatic | Exception CNS metastases Treated | Exception CNS metastases Asymptomatic
Item
patients with a history of symptomatic central nervous system metastases, unless treated and asymptomatic
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0686377 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0686377 (UMLS CUI [3,2])
C0231221 (UMLS CUI [3,3])
Autoimmune Disease | Exception Vitiligo | Exception Childhood atopic dermatitis resolved | Exception Psoriasis Independent of Systemic therapy | Exception GRAVE DISEASE EUTHYROID
Item
patients with history of autoimmune disease with certain exceptions such as vitiligo, resolved chilhood atopic dermatitis, psoriasis not requiring systemic therapy within the past 2 years, patients with history of grave's disease that are now euthyroid clinically and by lab testing
boolean
C0004364 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0042900 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1276071 (UMLS CUI [3,2])
C1514893 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0033860 (UMLS CUI [4,2])
C0332291 (UMLS CUI [4,3])
C1515119 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0744480 (UMLS CUI [5,2])
Allogeneic bone marrow transplantation | Stem cell transplant | Solid organ transplant
Item
history of allogeneic bone marrow, stem cell, or solid organ transplant
boolean
C0149615 (UMLS CUI [1])
C1504389 (UMLS CUI [2])
C0730400 (UMLS CUI [3])
Cancer treatment Systemic | Therapy, Investigational | Therapeutic radiology procedure | Adrenal Cortex Hormones Dose U/day | Prednisone Equivalent | Immunosuppressive Agents
Item
treatment with systemic cancer therapy or investigational therapy within 4 weeks of first study drug administration; radiation within 2 weeks; corticosteroids (greater than or equal to 10 mg prednisone or equivalent per day) or other immune suppressive drugs within 2 weeks of first study drug administration
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0949266 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0001617 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0456683 (UMLS CUI [4,3])
C0032952 (UMLS CUI [5,1])
C0205163 (UMLS CUI [5,2])
C0021081 (UMLS CUI [6])
Trauma surgery | Major surgery
Item
trauma or major surgery within 4 weeks of first study drug administration
boolean
C3714660 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0679637 (UMLS CUI [2])
Cardiovascular Disease | Gastrointestinal perforation | Gastrointestinal Hemorrhage | Pancreatitis | Diverticulitis
Item
history of clinically-significant cardiovascular disease; gastrointestinal perforation; gastrointestinal bleeding, acute pancreatitis or diverticulitis within 4 weeks of first study drug administration
boolean
C0007222 (UMLS CUI [1])
C0151664 (UMLS CUI [2])
C0017181 (UMLS CUI [3])
C0030305 (UMLS CUI [4])
C0012813 (UMLS CUI [5])
Virus Disease | Bacterial Infection | Systemic mycosis | Requirement Parenteral therapy
Item
active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days of first study drug administration
boolean
C0042769 (UMLS CUI [1])
C0004623 (UMLS CUI [2])
C0553576 (UMLS CUI [3])
C1514873 (UMLS CUI [4,1])
C0259961 (UMLS CUI [4,2])
Hepatitis B | Hepatitis C | Hepatitis B surface antigen positive | Hepatitis B core antigen positive | Hepatitis C test positive Polymerase Chain Reaction
Item
known history of hepatitis b or c infection or known positive test for hepatitis b surface antigen or core antigen, or hepatitis c polymerase chain reaction (pcr)
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0149709 (UMLS CUI [3])
C0262507 (UMLS CUI [4])
C1609517 (UMLS CUI [5,1])
C0032520 (UMLS CUI [5,2])
HIV Seropositivity | Acquired Immunodeficiency Syndrome
Item
known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome
boolean
C0019699 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
Hypersensitivity Recombinant Proteins | Hypersensitivity Polysorbate 80 | Hypersensitivity Excipient MGA271 | Hypersensitivity Excipient Pembrolizumab
Item
known hypersensitivity to recombinant proteins, polysorbate 80, or any excipient contained in the drug or vehicle formulation for mga271 or pembrolizumab.
boolean
C0020517 (UMLS CUI [1,1])
C0034861 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0032601 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0015237 (UMLS CUI [3,2])
C3273458 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0015237 (UMLS CUI [4,2])
C3658706 (UMLS CUI [4,3])