TriangleNCT03367741 · OUTCOME
Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Up to 4 years
What was measured
Survival estimates will be computed using the Kaplan-Meier method.
Analysis population: Pre-specified to only evaluate participants in Arm A and B; as Arm C was an exploratory cohort.
Groups in this outcome
Arm A (Cabozantinib S-malate, Nivolumab)
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
Arm B (Nivolumab)
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
| Group | Source count |
|---|---|
| Arm A (Cabozantinib S-malate, Nivolumab) | 36 |
| Arm B (Nivolumab) | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Cabozantinib S-malate, Nivolumab) | 13 | Not reported | 10.2 | 18.4 | Not reported |
| Arm B (Nivolumab) | 7.9 | Not reported | 6.1 | NA | insufficient number of participants with events |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.2
- upper Limit
- 18.4
- value
- 13
- comment
- insufficient number of participants with events
- group Id
- OG001
- lower Limit
- 6.1
- upper Limit
- NA
- value
- 7.9
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 18
- units
- Participants
- description
- Survival estimates will be computed using the Kaplan-Meier method.
- dispersion Type
- 90% Confidence Interval
- 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
- OG000
- 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
- OG001
- title
- Arm B (Nivolumab)
- param Type
- MEDIAN
- population Description
- Pre-specified to only evaluate participants in Arm A and B; as Arm C was an exploratory cohort.
- reporting Status
- POSTED
- time Frame
- Up to 4 years
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice