TriangleNCT03370276 · 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 of participants responded
- Interval / dispersion
- Not reported
- Time frame
- Up to 48 months
What was measured
Complete Response (CR): The disappearance of all measurable lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameters of measureable lesions, taking as reference the baseline sum longest diameter. 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). Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval of 6 weeks.
Analysis population: Participants evaluable for response
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 | 43 |
| Phase II - Cohort B | 42 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Lead in + Phase II: Cohort A | 22 | Not reported | Not reported | Not reported | Not reported |
| Phase II - Cohort B | 37 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 37
- denoms
- counts
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 42
- units
- Participants
- description
- Complete Response (CR): The disappearance of all measurable lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameters of measureable lesions, taking as reference the baseline sum longest diameter. 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). Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval of 6 weeks.
- 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
- NUMBER
- population Description
- Participants evaluable for response
- reporting Status
- POSTED
- time Frame
- Up to 48 months
- title
- Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants responded
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice