NCT03367741 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 36
- group Id
- BG001
- value
- 18
- group Id
- BG002
- value
- 23
- group Id
- BG003
- value
- 77
- units
- Participants
- groups
- description
- Patients receive cabozantinib s-malate PO QD on days 1-28 and nivolumab IV over 30 minutes on days 1 and 15, then on day 1 beginning cycle 5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, and blood sample collection throughout the study and undergo biopsy at screening and optionally at follow up. Biopsy Procedure: Undergo tumor biopsy Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT scan Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
- id
- BG000
- title
- Arm A (Cabozantinib S-malate, Nivolumab)
- description
- Patients receive nivolumab as in Arm A. Patients may cross-over to Arm A at the time of disease progression. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, and blood sample collection throughout the study and undergo biopsy at screening and optionally at follow up. Biopsy Procedure: Undergo tumor biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
- id
- BG001
- title
- Arm B (Nivolumab)
- description
- Patients with diagnosis of endometrial carcinosarcoma will be enrolled in the exploratory cohort (arm C) receiving combination of cabozantinib and nivolumab and will not be part of the statistical analysis.
- id
- BG002
- title
- Arm C (Exploratory Cohort)
- description
- Total of all reporting groups
- id
- BG003
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 44
- upper Limit
- 77
- value
- 67
- group Id
- BG001
- lower Limit
- 41
- upper Limit
- 83
- value
- 66
- group Id
- BG002
- lower Limit
- 53
- upper Limit
- 83
- value
- 62
- group Id
- BG003
- lower Limit
- 41
- upper Limit
- 83
- value
- 66.5
- denoms
- counts
- group Id
- BG000
- value
- 36
- group Id
- BG001
- value
- 18
- group Id
- BG002
- value
- 23
- group Id
- BG003
- value
- 77
- units
- Participants
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Customized
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 36
- group Id
- BG001
- value
- 18
- group Id
- BG002
- value
- 23
- group Id
- BG003
- value
- 77
- title
- Female
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- Male
- denoms
- counts
- group Id
- BG000
- value
- 36
- group Id
- BG001
- value
- 18
- group Id
- BG002
- value
- 23
- group Id
- BG003
- value
- 77
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG003
- value
- 0
- denoms
- counts
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Race and Ethnicity were not collected from any participant.
- title
- Race and Ethnicity Not Collected
- unit Of Measure
- Participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 36
- group Id
- BG001
- value
- 18
- group Id
- BG002
- value
- 23
- group Id
- BG003
- value
- 77
- units
- Participants
- groups
- description
- Patients receive cabozantinib s-malate PO QD on days 1-28 and nivolumab IV over 30 minutes on days 1 and 15, then on day 1 beginning cycle 5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, and blood sample collection throughout the study and undergo biopsy at screening and optionally at follow up. Biopsy Procedure: Undergo tumor biopsy Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT scan Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
- id
- BG000
- title
- Arm A (Cabozantinib S-malate, Nivolumab)
- description
- Patients receive nivolumab as in Arm A. Patients may cross-over to Arm A at the time of disease progression. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, and blood sample collection throughout the study and undergo biopsy at screening and optionally at follow up. Biopsy Procedure: Undergo tumor biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
- id
- BG001
- title
- Arm B (Nivolumab)
- description
- Patients with diagnosis of endometrial carcinosarcoma will be enrolled in the exploratory cohort (arm C) receiving combination of cabozantinib and nivolumab and will not be part of the statistical analysis.
- id
- BG002
- title
- Arm C (Exploratory Cohort)
- description
- Total of all reporting groups
- id
- BG003
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 44
- upper Limit
- 77
- value
- 67
- group Id
- BG001
- lower Limit
- 41
- upper Limit
- 83
- value
- 66
- group Id
- BG002
- lower Limit
- 53
- upper Limit
- 83
- value
- 62
- group Id
- BG003
- lower Limit
- 41
- upper Limit
- 83
- value
- 66.5
- denoms
- counts
- group Id
- BG000
- value
- 36
- group Id
- BG001
- value
- 18
- group Id
- BG002
- value
- 23
- group Id
- BG003
- value
- 77
- units
- Participants
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Customized
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 36
- group Id
- BG001
- value
- 18
- group Id
- BG002
- value
- 23
- group Id
- BG003
- value
- 77
- title
- Female
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- Male
- denoms
- counts
- group Id
- BG000
- value
- 36
- group Id
- BG001
- value
- 18
- group Id
- BG002
- value
- 23
- group Id
- BG003
- value
- 77
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG003
- value
- 0
- denoms
- counts
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Race and Ethnicity were not collected from any participant.
- title
- Race and Ethnicity Not Collected
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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