TriangleNCT03370276 · OUTCOME
Progression Free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- at 12 months
What was measured
Progressive Disease (PD): At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).
Analysis population: Evaluable participants
Groups in this outcome
Phase I Lead in + Phase II: Cohort A
Patients who had progressed on at least one prior line of treatment for their recurrent and/or metastatic HNSCC Participants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.
Phase II - Cohort B
Patients who have not had any prior treatment for their recurrent and/or metastatic HNSCC Participants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.
| Group | Source count |
|---|---|
| Phase I Lead in + Phase II: Cohort A | 45 |
| Phase II - Cohort B | 43 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Lead in + Phase II: Cohort A | 3.35 | Not reported | 2.56 | 7.13 | Not reported |
| Phase II - Cohort B | 6.15 | Not reported | 3.06 | NA | Not reached |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.56
- upper Limit
- 7.13
- value
- 3.35
- comment
- Not reached
- group Id
- OG001
- lower Limit
- 3.06
- upper Limit
- NA
- value
- 6.15
- denoms
- counts
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 43
- units
- Participants
- description
- Progressive Disease (PD): At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients who had progressed on at least one prior line of treatment for their recurrent and/or metastatic HNSCC Participants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.
- id
- OG000
- title
- Phase I Lead in + Phase II: Cohort A
- description
- Patients who have not had any prior treatment for their recurrent and/or metastatic HNSCC Participants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.
- id
- OG001
- title
- Phase II - Cohort B
- param Type
- MEDIAN
- population Description
- Evaluable participants
- reporting Status
- POSTED
- time Frame
- at 12 months
- title
- Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice