TriangleNCT01693562 · OUTCOME
Number of Participants With Best Overall Response (BOR) 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
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- 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 BOR assessed by BICR based on RECIST v1.1 in NSCLC and SCCHN cohorts is reported. The BOR includes CR, PR, stable disease (SD), progressive disease (PD), and non-evaluable (NE). The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. The PD is defined at least 20% increase in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The NE is defined as either when no or only a subset of lesion measurements are made at an assessment.
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.
Groups in this outcome
Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)
Participants with 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) | 55 |
| Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) | 275 |
Reported measurements
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) | 3 | Not reported | Not reported | Not reported | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) | 4 | Not reported | Not reported | Not reported | Not reported |
| Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) | 39 | Not reported | Not reported | Not reported | Not reported |
SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) | 10 | Not reported | Not reported | Not reported | Not reported |
| Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) | 80 | Not reported | Not reported | Not reported | Not reported |
PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) | 31 | Not reported | Not reported | Not reported | Not reported |
| Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) | 110 | Not reported | Not reported | Not reported | Not reported |
NE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) | 10 | Not reported | Not reported | Not reported | Not reported |
| Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) | 43 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- title
- CR
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 39
- title
- PR
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 80
- title
- SD
- categories
- measurements
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 110
- title
- PD
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 43
- title
- NE
- denoms
- counts
- group Id
- OG000
- value
- 55
- group Id
- OG001
- value
- 275
- units
- Participants
- description
- The BOR assessed by BICR based on RECIST v1.1 in NSCLC and SCCHN cohorts is reported. The BOR includes CR, PR, stable disease (SD), progressive disease (PD), and non-evaluable (NE). The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. The PD is defined at least 20% increase in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The NE is defined as either when no or only a subset of lesion measurements are made at an assessment.
- groups
- description
- Participants with 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
- COUNT_OF_PARTICIPANTS
- 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.
- 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
- Number of Participants With Best Overall Response (BOR) Assessed by BICR in NSCLC and SCCHN Cohort in the Dose-expansion Phase
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice