TriangleNCT04514484 · OUTCOME
Best Overall Response (Off Treatment)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- percentage of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 24 months
What was measured
Percentage of patients (who are off treatment) who experienced either a Complete Response (CR) or Partial Response (PR) during off treatment period. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Analysis population: Off treatment patients who were evaluated for efficacy.
Groups in this outcome
Treatment (Cabozantinib S-malate, Nivolumab)
Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
| Group | Source count |
|---|---|
| Treatment (Cabozantinib S-malate, Nivolumab) | 6 |
Reported measurements
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Cabozantinib S-malate, Nivolumab) | 0 | Not reported | 0 | 45.9 | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Cabozantinib S-malate, Nivolumab) | 0 | Not reported | 0 | 45.9 | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Cabozantinib S-malate, Nivolumab) | 83.3 | Not reported | 35.9 | 99.6 | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Cabozantinib S-malate, Nivolumab) | 16.7 | Not reported | 0.4 | 64.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 45.9
- value
- 0
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 45.9
- value
- 0
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- lower Limit
- 35.9
- upper Limit
- 99.6
- value
- 83.3
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.4
- upper Limit
- 64.1
- value
- 16.7
- title
- Progressive Disease
- denoms
- counts
- group Id
- OG000
- value
- 6
- units
- Participants
- description
- Percentage of patients (who are off treatment) who experienced either a Complete Response (CR) or Partial Response (PR) during off treatment period. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
- id
- OG000
- title
- Treatment (Cabozantinib S-malate, Nivolumab)
- param Type
- MEDIAN
- population Description
- Off treatment patients who were evaluated for efficacy.
- reporting Status
- POSTED
- time Frame
- Up to 24 months
- title
- Best Overall Response (Off Treatment)
- type
- SECONDARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice