ID

37037

Beschreibung

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

Stichworte

Versionen (1)
  1. 01.07.19 01.07.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

1. Juli 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Renal Cell Carcinoma NCT01984242

Englisch

Eligibility Renal Cell Carcinoma NCT01984242

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Adult | Age

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Measurable Disease

Datentyp

boolean

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

Karnofsky Performance Status

Datentyp

boolean

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

Hematologic function | Organ function

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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)
Beschreibung

Pleural effusion Uncontrolled | Pericardial effusion | Ascites Requirement Drainage Repeated

Datentyp

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
Beschreibung

Hypercalcemia Uncontrolled | Hypercalcemia Symptomatic

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Life Expectancy

Datentyp

boolean

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

Pregnancy | Breast Feeding

Datentyp

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
Beschreibung

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

Datentyp

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)
Beschreibung

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

Datentyp

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:
Beschreibung

Bevacizumab Specific Exclusion Criteria | Sunitinib Specific Exclusion Criteria

Datentyp

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
Beschreibung

Poor hypertension control

Datentyp

boolean

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

Hypertensive crisis | Hypertensive Encephalopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0020546
UMLS CUI [2]
C0151620
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Ähnliche Modelle

Eligibility Renal Cell Carcinoma NCT01984242

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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