0 Ratings
ID

37037

Description

A Phase 2 Study of MPDL3280A (an Engineered Anti-PDL1 Antibody) as Monotherapy or in Combination With Avastin (Bevacizumab) Compared to Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01984242

Link

https://clinicaltrials.gov/show/NCT01984242

Keywords

Versions (1)
  1. 7/1/19 7/1/19 -
Copyright Holder

See clinicaltrials.gov

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July 1, 2019

DOI

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License

Creative Commons BY 4.0
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    Eligibility Renal Cell Carcinoma NCT01984242

    English

    Eligibility Renal Cell Carcinoma NCT01984242

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    adult patients >/= 18 years of age
    Description

    Adult | Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001675
    UMLS CUI [2]
    C0001779
    unresectable advanced or metastatic renal cell carcinoma with component of clear cell histology and/or component of sarcomatoid histology that has not been previously treated with any systemic agents, including treatment in the adjuvant setting
    Description

    Renal Cell Carcinoma Advanced unresectable | Metastatic Renal Cell Cancer unresectable | Clear cell Component Histology | Sarcomatoid Component Histology | Systemic therapy Absent | Adjuvant therapy Absent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007134
    UMLS CUI [1,2]
    C0205179
    UMLS CUI [1,3]
    C1519810
    UMLS CUI [2,1]
    C0278678
    UMLS CUI [2,2]
    C1519810
    UMLS CUI [3,1]
    C0229473
    UMLS CUI [3,2]
    C1705248
    UMLS CUI [3,3]
    C0344441
    UMLS CUI [4,1]
    C1519183
    UMLS CUI [4,2]
    C1705248
    UMLS CUI [4,3]
    C0344441
    UMLS CUI [5,1]
    C1515119
    UMLS CUI [5,2]
    C0332197
    UMLS CUI [6,1]
    C0677850
    UMLS CUI [6,2]
    C0332197
    measurable disease, as defined by recist v1.1
    Description

    Measurable Disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    karnofsky performance score >/= 70
    Description

    Karnofsky Performance Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0206065
    adequate hematologic and end-organ function as defined by protocol
    Description

    Hematologic function | Organ function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0221130
    UMLS CUI [2]
    C0678852
    women of childbearing potential and male patients must agree to use adequate methods of contraception as defined by protocol during the treatment period and for at least 6 months after the last dose of mpdl3280a or avastin (bevacizumab) for patients randomized to arm a, or at least 90 days after the last dose of mpdl3280a monotherapy for patients randomized to arm b, or at least 30 days after the last dose of sunitinib for patients randomized to arm c.
    Description

    Childbearing Potential Contraceptive methods | Gender Contraceptive methods | MPDL3280A | Avastin | bevacizumab | sunitinib

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0700589
    UMLS CUI [2,1]
    C0079399
    UMLS CUI [2,2]
    C0700589
    UMLS CUI [3]
    C3827082
    UMLS CUI [4]
    C1135130
    UMLS CUI [5]
    C0796392
    UMLS CUI [6]
    C1176020
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    radiotherapy for rcc within 28 days prior to cycle 1, day 1 with the exception of: single-fraction radiotherapy given for the indication of pain control
    Description

    Therapeutic radiology procedure Renal Cell Carcinoma | Exception Therapeutic radiology procedure Fraction Single | Exception Indication Pain control

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1522449
    UMLS CUI [1,2]
    C0007134
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C1522449
    UMLS CUI [2,3]
    C1710555
    UMLS CUI [2,4]
    C0205171
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C3146298
    UMLS CUI [3,3]
    C1304888
    known active malignancies or metastasis of the brain or spinal cord or leptomeningeal disease, as determined by ct or mri evaluation during screening and prior radiographic assessments
    Description

    Brain Neoplasms CT | Metastatic malignant neoplasm to brain CT | Spinal Cord Neoplasms CT | Secondary malignant neoplasm of spinal cord CT | Leptomeningeal Neoplasms CT | Brain Neoplasms MRI | Metastatic malignant neoplasm to brain MRI | Spinal Cord Neoplasms MRI | Secondary malignant neoplasm of spinal cord MRI | Leptomeningeal Neoplasms MRI | Brain Neoplasms Diagnostic radiologic examination | Metastatic malignant neoplasm to brain Diagnostic radiologic examination | Spinal Cord Neoplasms Diagnostic radiologic examination | Secondary malignant neoplasm of spinal cord Diagnostic radiologic examination | Leptomeningeal Neoplasms Diagnostic radiologic examination

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0006118
    UMLS CUI [1,2]
    C0040405
    UMLS CUI [2,1]
    C0220650
    UMLS CUI [2,2]
    C0040405
    UMLS CUI [3,1]
    C0037930
    UMLS CUI [3,2]
    C0040405
    UMLS CUI [4,1]
    C0347016
    UMLS CUI [4,2]
    C0040405
    UMLS CUI [5,1]
    C0751297
    UMLS CUI [5,2]
    C0040405
    UMLS CUI [6,1]
    C0006118
    UMLS CUI [6,2]
    C0024485
    UMLS CUI [7,1]
    C0220650
    UMLS CUI [7,2]
    C0024485
    UMLS CUI [8,1]
    C0037930
    UMLS CUI [8,2]
    C0024485
    UMLS CUI [9,1]
    C0347016
    UMLS CUI [9,2]
    C0024485
    UMLS CUI [10,1]
    C0751297
    UMLS CUI [10,2]
    C0024485
    UMLS CUI [11,1]
    C0006118
    UMLS CUI [11,2]
    C0043299
    UMLS CUI [12,1]
    C0220650
    UMLS CUI [12,2]
    C0043299
    UMLS CUI [13,1]
    C0037930
    UMLS CUI [13,2]
    C0043299
    UMLS CUI [14,1]
    C0347016
    UMLS CUI [14,2]
    C0043299
    UMLS CUI [15,1]
    C0751297
    UMLS CUI [15,2]
    C0043299
    uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
    Description

    Pleural effusion Uncontrolled | Pericardial effusion | Ascites Requirement Drainage Repeated

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0032227
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [2]
    C0031039
    UMLS CUI [3,1]
    C0003962
    UMLS CUI [3,2]
    C1514873
    UMLS CUI [3,3]
    C0013103
    UMLS CUI [3,4]
    C0205341
    uncontrolled hypercalcemia or symptomatic hypercalcemia
    Description

    Hypercalcemia Uncontrolled | Hypercalcemia Symptomatic

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020437
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [2,1]
    C0020437
    UMLS CUI [2,2]
    C0231220
    malignancies other than rcc within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death, treated with expected curative outcome
    Description

    Malignant Neoplasms | Exception Renal Cell Carcinoma | Exception Low Risk Metastasis | Exception Low Risk Death | Exception Outcome Curative Expected

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0007134
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C3538919
    UMLS CUI [3,3]
    C0027627
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C3538919
    UMLS CUI [4,3]
    C0011065
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C1274040
    UMLS CUI [5,3]
    C1880198
    UMLS CUI [5,4]
    C1517001
    life expectancy of < 12 weeks
    Description

    Life Expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    pregnant and lactating women
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    Description

    Allergic Reaction Severe Chimeric antibody | Anaphylaxis Severe Chimeric antibody | Severe allergy Chimeric antibody | Allergic Reaction Severe Humanized Antibodies | Anaphylaxis Severe Humanized Antibodies | Severe allergy Humanized Antibodies | Allergic Reaction Severe Fusion protein | Anaphylaxis Severe Fusion protein | Severe allergy Fusion protein

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1527304
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [1,3]
    C0598622
    UMLS CUI [2,1]
    C0002792
    UMLS CUI [2,2]
    C0205082
    UMLS CUI [2,3]
    C0598622
    UMLS CUI [3,1]
    C2945656
    UMLS CUI [3,2]
    C0598622
    UMLS CUI [4,1]
    C1527304
    UMLS CUI [4,2]
    C0205082
    UMLS CUI [4,3]
    C2985546
    UMLS CUI [5,1]
    C0002792
    UMLS CUI [5,2]
    C0205082
    UMLS CUI [5,3]
    C2985546
    UMLS CUI [6,1]
    C2945656
    UMLS CUI [6,2]
    C2985546
    UMLS CUI [7,1]
    C1527304
    UMLS CUI [7,2]
    C0205082
    UMLS CUI [7,3]
    C0162768
    UMLS CUI [8,1]
    C0002792
    UMLS CUI [8,2]
    C0205082
    UMLS CUI [8,3]
    C0162768
    UMLS CUI [9,1]
    C2945656
    UMLS CUI [9,2]
    C0162768
    history of autoimmune disease (patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study)
    Description

    Autoimmune Disease | Exception Hypothyroidism Relationship Autoimmune Diseases | Exception Thyroid hormone replacement therapy Dose Stable

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004364
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0020676
    UMLS CUI [2,3]
    C0439849
    UMLS CUI [2,4]
    C0004364
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C2242640
    UMLS CUI [3,3]
    C0178602
    UMLS CUI [3,4]
    C0205360
    bevacizumab- and sunitinib-specific exclusions:
    Description

    Bevacizumab Specific Exclusion Criteria | Sunitinib Specific Exclusion Criteria

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0796392
    UMLS CUI [1,2]
    C0205369
    UMLS CUI [1,3]
    C0680251
    UMLS CUI [2,1]
    C1176020
    UMLS CUI [2,2]
    C0205369
    UMLS CUI [2,3]
    C0680251
    inadequately controlled hypertension
    Description

    Poor hypertension control

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0421190
    prior history of hypertensive crisis or hypertensive encephalopathy
    Description

    Hypertensive crisis | Hypertensive Encephalopathy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0020546
    UMLS CUI [2]
    C0151620
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    Similar models

    Eligibility Renal Cell Carcinoma NCT01984242

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Adult | Age
    Item
    adult patients >/= 18 years of age
    boolean
    C0001675 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    Renal Cell Carcinoma Advanced unresectable | Metastatic Renal Cell Cancer unresectable | Clear cell Component Histology | Sarcomatoid Component Histology | Systemic therapy Absent | Adjuvant therapy Absent
    Item
    unresectable advanced or metastatic renal cell carcinoma with component of clear cell histology and/or component of sarcomatoid histology that has not been previously treated with any systemic agents, including treatment in the adjuvant setting
    boolean
    C0007134 (UMLS CUI [1,1])
    C0205179 (UMLS CUI [1,2])
    C1519810 (UMLS CUI [1,3])
    C0278678 (UMLS CUI [2,1])
    C1519810 (UMLS CUI [2,2])
    C0229473 (UMLS CUI [3,1])
    C1705248 (UMLS CUI [3,2])
    C0344441 (UMLS CUI [3,3])
    C1519183 (UMLS CUI [4,1])
    C1705248 (UMLS CUI [4,2])
    C0344441 (UMLS CUI [4,3])
    C1515119 (UMLS CUI [5,1])
    C0332197 (UMLS CUI [5,2])
    C0677850 (UMLS CUI [6,1])
    C0332197 (UMLS CUI [6,2])
    Measurable Disease
    Item
    measurable disease, as defined by recist v1.1
    boolean
    C1513041 (UMLS CUI [1])
    Karnofsky Performance Status
    Item
    karnofsky performance score >/= 70
    boolean
    C0206065 (UMLS CUI [1])
    Hematologic function | Organ function
    Item
    adequate hematologic and end-organ function as defined by protocol
    boolean
    C0221130 (UMLS CUI [1])
    C0678852 (UMLS CUI [2])
    Childbearing Potential Contraceptive methods | Gender Contraceptive methods | MPDL3280A | Avastin | bevacizumab | sunitinib
    Item
    women of childbearing potential and male patients must agree to use adequate methods of contraception as defined by protocol during the treatment period and for at least 6 months after the last dose of mpdl3280a or avastin (bevacizumab) for patients randomized to arm a, or at least 90 days after the last dose of mpdl3280a monotherapy for patients randomized to arm b, or at least 30 days after the last dose of sunitinib for patients randomized to arm c.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C0079399 (UMLS CUI [2,1])
    C0700589 (UMLS CUI [2,2])
    C3827082 (UMLS CUI [3])
    C1135130 (UMLS CUI [4])
    C0796392 (UMLS CUI [5])
    C1176020 (UMLS CUI [6])
    Item Group
    C0680251 (UMLS CUI)
    Therapeutic radiology procedure Renal Cell Carcinoma | Exception Therapeutic radiology procedure Fraction Single | Exception Indication Pain control
    Item
    radiotherapy for rcc within 28 days prior to cycle 1, day 1 with the exception of: single-fraction radiotherapy given for the indication of pain control
    boolean
    C1522449 (UMLS CUI [1,1])
    C0007134 (UMLS CUI [1,2])
    C1705847 (UMLS CUI [2,1])
    C1522449 (UMLS CUI [2,2])
    C1710555 (UMLS CUI [2,3])
    C0205171 (UMLS CUI [2,4])
    C1705847 (UMLS CUI [3,1])
    C3146298 (UMLS CUI [3,2])
    C1304888 (UMLS CUI [3,3])
    Brain Neoplasms CT | Metastatic malignant neoplasm to brain CT | Spinal Cord Neoplasms CT | Secondary malignant neoplasm of spinal cord CT | Leptomeningeal Neoplasms CT | Brain Neoplasms MRI | Metastatic malignant neoplasm to brain MRI | Spinal Cord Neoplasms MRI | Secondary malignant neoplasm of spinal cord MRI | Leptomeningeal Neoplasms MRI | Brain Neoplasms Diagnostic radiologic examination | Metastatic malignant neoplasm to brain Diagnostic radiologic examination | Spinal Cord Neoplasms Diagnostic radiologic examination | Secondary malignant neoplasm of spinal cord Diagnostic radiologic examination | Leptomeningeal Neoplasms Diagnostic radiologic examination
    Item
    known active malignancies or metastasis of the brain or spinal cord or leptomeningeal disease, as determined by ct or mri evaluation during screening and prior radiographic assessments
    boolean
    C0006118 (UMLS CUI [1,1])
    C0040405 (UMLS CUI [1,2])
    C0220650 (UMLS CUI [2,1])
    C0040405 (UMLS CUI [2,2])
    C0037930 (UMLS CUI [3,1])
    C0040405 (UMLS CUI [3,2])
    C0347016 (UMLS CUI [4,1])
    C0040405 (UMLS CUI [4,2])
    C0751297 (UMLS CUI [5,1])
    C0040405 (UMLS CUI [5,2])
    C0006118 (UMLS CUI [6,1])
    C0024485 (UMLS CUI [6,2])
    C0220650 (UMLS CUI [7,1])
    C0024485 (UMLS CUI [7,2])
    C0037930 (UMLS CUI [8,1])
    C0024485 (UMLS CUI [8,2])
    C0347016 (UMLS CUI [9,1])
    C0024485 (UMLS CUI [9,2])
    C0751297 (UMLS CUI [10,1])
    C0024485 (UMLS CUI [10,2])
    C0006118 (UMLS CUI [11,1])
    C0043299 (UMLS CUI [11,2])
    C0220650 (UMLS CUI [12,1])
    C0043299 (UMLS CUI [12,2])
    C0037930 (UMLS CUI [13,1])
    C0043299 (UMLS CUI [13,2])
    C0347016 (UMLS CUI [14,1])
    C0043299 (UMLS CUI [14,2])
    C0751297 (UMLS CUI [15,1])
    C0043299 (UMLS CUI [15,2])
    Pleural effusion Uncontrolled | Pericardial effusion | Ascites Requirement Drainage Repeated
    Item
    uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
    boolean
    C0032227 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0031039 (UMLS CUI [2])
    C0003962 (UMLS CUI [3,1])
    C1514873 (UMLS CUI [3,2])
    C0013103 (UMLS CUI [3,3])
    C0205341 (UMLS CUI [3,4])
    Hypercalcemia Uncontrolled | Hypercalcemia Symptomatic
    Item
    uncontrolled hypercalcemia or symptomatic hypercalcemia
    boolean
    C0020437 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0020437 (UMLS CUI [2,1])
    C0231220 (UMLS CUI [2,2])
    Malignant Neoplasms | Exception Renal Cell Carcinoma | Exception Low Risk Metastasis | Exception Low Risk Death | Exception Outcome Curative Expected
    Item
    malignancies other than rcc within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death, treated with expected curative outcome
    boolean
    C0006826 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0007134 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C3538919 (UMLS CUI [3,2])
    C0027627 (UMLS CUI [3,3])
    C1705847 (UMLS CUI [4,1])
    C3538919 (UMLS CUI [4,2])
    C0011065 (UMLS CUI [4,3])
    C1705847 (UMLS CUI [5,1])
    C1274040 (UMLS CUI [5,2])
    C1880198 (UMLS CUI [5,3])
    C1517001 (UMLS CUI [5,4])
    Life Expectancy
    Item
    life expectancy of < 12 weeks
    boolean
    C0023671 (UMLS CUI [1])
    Pregnancy | Breast Feeding
    Item
    pregnant and lactating women
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Allergic Reaction Severe Chimeric antibody | Anaphylaxis Severe Chimeric antibody | Severe allergy Chimeric antibody | Allergic Reaction Severe Humanized Antibodies | Anaphylaxis Severe Humanized Antibodies | Severe allergy Humanized Antibodies | Allergic Reaction Severe Fusion protein | Anaphylaxis Severe Fusion protein | Severe allergy Fusion protein
    Item
    history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    boolean
    C1527304 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0598622 (UMLS CUI [1,3])
    C0002792 (UMLS CUI [2,1])
    C0205082 (UMLS CUI [2,2])
    C0598622 (UMLS CUI [2,3])
    C2945656 (UMLS CUI [3,1])
    C0598622 (UMLS CUI [3,2])
    C1527304 (UMLS CUI [4,1])
    C0205082 (UMLS CUI [4,2])
    C2985546 (UMLS CUI [4,3])
    C0002792 (UMLS CUI [5,1])
    C0205082 (UMLS CUI [5,2])
    C2985546 (UMLS CUI [5,3])
    C2945656 (UMLS CUI [6,1])
    C2985546 (UMLS CUI [6,2])
    C1527304 (UMLS CUI [7,1])
    C0205082 (UMLS CUI [7,2])
    C0162768 (UMLS CUI [7,3])
    C0002792 (UMLS CUI [8,1])
    C0205082 (UMLS CUI [8,2])
    C0162768 (UMLS CUI [8,3])
    C2945656 (UMLS CUI [9,1])
    C0162768 (UMLS CUI [9,2])
    Autoimmune Disease | Exception Hypothyroidism Relationship Autoimmune Diseases | Exception Thyroid hormone replacement therapy Dose Stable
    Item
    history of autoimmune disease (patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study)
    boolean
    C0004364 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0020676 (UMLS CUI [2,2])
    C0439849 (UMLS CUI [2,3])
    C0004364 (UMLS CUI [2,4])
    C1705847 (UMLS CUI [3,1])
    C2242640 (UMLS CUI [3,2])
    C0178602 (UMLS CUI [3,3])
    C0205360 (UMLS CUI [3,4])
    Bevacizumab Specific Exclusion Criteria | Sunitinib Specific Exclusion Criteria
    Item
    bevacizumab- and sunitinib-specific exclusions:
    boolean
    C0796392 (UMLS CUI [1,1])
    C0205369 (UMLS CUI [1,2])
    C0680251 (UMLS CUI [1,3])
    C1176020 (UMLS CUI [2,1])
    C0205369 (UMLS CUI [2,2])
    C0680251 (UMLS CUI [2,3])
    Poor hypertension control
    Item
    inadequately controlled hypertension
    boolean
    C0421190 (UMLS CUI [1])
    Hypertensive crisis | Hypertensive Encephalopathy
    Item
    prior history of hypertensive crisis or hypertensive encephalopathy
    boolean
    C0020546 (UMLS CUI [1])
    C0151620 (UMLS CUI [2])
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