TriangleNCT01772004 · OUTCOME
Efficacy Expansion Cohorts: Duration of Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Per Independent Endpoint Review Committee (IERC)
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
- Efficacy Expansion: Baseline up to Day 1072
What was measured
Duration of response according to modified irRC, per investigator assessment was calculated for each participant with a confirmed response (immune-related complete response \[irCR\] or immune-related partial response \[irPR\]) as the time from the first observation of response to the first observation of documented disease progression (or death within 12 weeks of the last tumor assessment). irCR: Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions). Results were calculated based on Kaplan-Meier estimates.
Analysis population: FAS included all participants who have received at least 1 dose of study treatment. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure. This outcome measure was planned to be analyzed in Efficacy expansion cohorts only.
Groups in this outcome
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
| Group | Source count |
|---|---|
| Efficacy Expansion Cohort: Ovarian Cancer | 4 |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 32 |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 7 |
| Efficacy Expansion Cohort: HNSCC | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Efficacy Expansion Cohort: Ovarian Cancer | NA | Not reported | NA | NA | Median, lower and upper limit of confidence interval could not be calculated because no participant had an event. |
| Efficacy Expansion Cohort: Urothelial Carcinoma | NA | Not reported | 9.00 | NA | Due to small number of events, estimates (Median and upper limit of 95%confidence interval) from Kaplan-Meier survival curves could not be derived. |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | NA | Not reported | 4.24 | NA | Due to small number of events, estimates (Median and upper limit of 95%confidence interval) from Kaplan-Meier survival curves could not be derived. |
| Efficacy Expansion Cohort: HNSCC | NA | Not reported | 4.17 | NA | Due to small number of events, estimates (Median and upper limit of 95%confidence interval) from Kaplan-Meier survival curves could not be derived. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median, lower and upper limit of confidence interval could not be calculated because no participant had an event.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Due to small number of events, estimates (Median and upper limit of 95%confidence interval) from Kaplan-Meier survival curves could not be derived.
- group Id
- OG001
- lower Limit
- 9.00
- upper Limit
- NA
- value
- NA
- comment
- Due to small number of events, estimates (Median and upper limit of 95%confidence interval) from Kaplan-Meier survival curves could not be derived.
- group Id
- OG002
- lower Limit
- 4.24
- upper Limit
- NA
- value
- NA
- comment
- Due to small number of events, estimates (Median and upper limit of 95%confidence interval) from Kaplan-Meier survival curves could not be derived.
- group Id
- OG003
- lower Limit
- 4.17
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 32
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 14
- units
- Participants
- description
- Duration of response according to modified irRC, per investigator assessment was calculated for each participant with a confirmed response (immune-related complete response \[irCR\] or immune-related partial response \[irPR\]) as the time from the first observation of response to the first observation of documented disease progression (or death within 12 weeks of the last tumor assessment). irCR: Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions). Results were calculated based on Kaplan-Meier estimates.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG000
- title
- Efficacy Expansion Cohort: Ovarian Cancer
- description
- Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG001
- title
- Efficacy Expansion Cohort: Urothelial Carcinoma
- description
- Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG002
- title
- Efficacy Expansion Cohort: GC/GEJC, Third Line
- description
- Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG003
- title
- Efficacy Expansion Cohort: HNSCC
- param Type
- MEDIAN
- population Description
- FAS included all participants who have received at least 1 dose of study treatment. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure. This outcome measure was planned to be analyzed in Efficacy expansion cohorts only.
- reporting Status
- POSTED
- time Frame
- Efficacy Expansion: Baseline up to Day 1072
- title
- Efficacy Expansion Cohorts: Duration of Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Per Independent Endpoint Review Committee (IERC)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice