TriangleNCT01693562 · OUTCOME
Duration of Response (DoR) Assessed by BICR in NSCLC and SCCHN Cohort in the Dose-expansion Phase
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
- From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)
What was measured
The DoR assessed by BICR in NSCLC and SCCHN cohorts is reported. The DoR is defined as the duration from the first documentation of objective response (OR) (confirmed CR or confirmed PR) to the first documented disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 28 days with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between. The DoR was estimated using Kaplan-Meier method.
Analysis population: Participants in FAS population with NSCLC and SCCHN were analyzed. FAS population included all participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 weeks by 16Oct2017. The DoR was analyzed for those participants who achieved OR.
Groups in this outcome
Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)
Participants with squamous SCCHN received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)
Participants with NSCLC received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
| Group | Source count |
|---|---|
| Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) | 4 |
| Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) | 42 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) | 12.37 | Not reported | 3.5 | NA | Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis. |
| Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) | 17.74 | Not reported | 5.6 | 38.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
- group Id
- OG000
- lower Limit
- 3.5
- upper Limit
- NA
- value
- 12.37
- group Id
- OG001
- lower Limit
- 5.6
- upper Limit
- 38.0
- value
- 17.74
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 42
- units
- Participants
- description
- The DoR assessed by BICR in NSCLC and SCCHN cohorts is reported. The DoR is defined as the duration from the first documentation of objective response (OR) (confirmed CR or confirmed PR) to the first documented disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 28 days with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between. The DoR was estimated using Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with squamous SCCHN received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG000
- title
- Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)
- description
- Participants with NSCLC received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG001
- title
- Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)
- param Type
- MEDIAN
- population Description
- Participants in FAS population with NSCLC and SCCHN were analyzed. FAS population included all participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 weeks by 16Oct2017. The DoR was analyzed for those participants who achieved OR.
- reporting Status
- POSTED
- time Frame
- From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)
- title
- Duration of Response (DoR) Assessed by BICR in NSCLC and SCCHN Cohort in the Dose-expansion Phase
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice