TriangleNCT03367741 · OUTCOME
Overall Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage
- Interval / dispersion
- Not reported
- Time frame
- Up to 1 year
What was measured
Summary statistics, such as mean, median, counts and proportion, will be used to summarize the patients. Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Non-parametric tests such as Spearman correlation coefficients, Fisher's exact tests and Wilcoxon rank sum test may be substituted if necessary. 95% percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.
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) | 25 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Nivolumab) | 11 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 11
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 18
- units
- Participants
- description
- Summary statistics, such as mean, median, counts and proportion, will be used to summarize the patients. Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Non-parametric tests such as Spearman correlation coefficients, Fisher's exact tests and Wilcoxon rank sum test may be substituted if necessary. 95% percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.
- 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
- NUMBER
- 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 1 year
- title
- Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- Percentage
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice