TriangleNCT01772004 · OUTCOME
Dose Expansion Cohort: Duration of Response According to Modified Immune-Related Response Criteria (irRC) Per Investigator Assessment
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
- Dose Expansion: Baseline up to Day 2023
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. Data for this outcome measure is reported for the participants with Complete or Partial response.
Groups in this outcome
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Primary Expansion Cohort: Metastatic Breast Cancer
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Adrenocortical Carcinoma
Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Melanoma
Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary 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 secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary 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 secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
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 |
|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 28 |
| Primary Expansion Cohort: NSCLC, First Line | 35 |
| Primary Expansion Cohort: Metastatic Breast Cancer | 7 |
| Primary Expansion Cohort: GC/GEJC Progressed | 5 |
| Primary Expansion Cohort: GC/GEJC Non Progressed | 6 |
| Secondary Expansion Cohort: Colorectal Cancer | 0 |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 0 |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 3 |
| Secondary Expansion Cohort: Melanoma | 11 |
| Secondary Expansion Cohort: Mesothelioma | 5 |
| Secondary Expansion Cohort: Urothelial Carcinoma | 7 |
| Secondary Expansion Cohort: Ovarian Cancer | 16 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 11 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 2 |
| Efficacy Expansion Cohort: Ovarian Cancer | 7 |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 34 |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 8 |
| Efficacy Expansion Cohort: HNSCC | 21 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 21.13 | Not reported | 11.07 | NA | Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive. |
| Primary Expansion Cohort: NSCLC, First Line | NA | Not reported | NA | NA | Median, lower and upper limit of confidence interval could not be calculated because no participant had an event. |
| Primary Expansion Cohort: Metastatic Breast Cancer | 8.31 | Not reported | 6.60 | 22.67 | Not reported |
| Primary Expansion Cohort: GC/GEJC Progressed | 4.14 | Not reported | 2.83 | 8.34 | Not reported |
| Primary Expansion Cohort: GC/GEJC Non Progressed | 22.23 | Not reported | 4.04 | NA | Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive. |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | NA | Not reported | NA | NA | Median, lower and upper limit of confidence interval could not be calculated because no participant had an event. |
| Secondary Expansion Cohort: Melanoma | NA | Not reported | 2.63 | NA | Due to small number of events, estimates (median and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive. |
| Secondary Expansion Cohort: Mesothelioma | 15.21 | Not reported | 11.07 | NA | Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive. |
| Secondary Expansion Cohort: Urothelial Carcinoma | NA | Not reported | NA | NA | As per planned analysis, data was analyzed in form of graph and no descriptive analysis was performed. |
| Secondary Expansion Cohort: Ovarian Cancer | 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 derive. |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 10.61 | Not reported | 2.79 | NA | Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive. |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | NA | Not reported | 6.93 | NA | Due to small number of events, estimates (median and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive. |
| 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 | NA | NA | As per planned analysis, data was analyzed in form of graph and no descriptive analysis was performed. |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | NA | Not reported | 2.79 | NA | Due to small number of events, estimates (median and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive. |
| Efficacy Expansion Cohort: HNSCC | NA | Not reported | 12.45 | NA | Due to small number of events, estimates (median and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive. |
Complete source fields
- classes
- categories
- measurements
- comment
- Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
- group Id
- OG000
- lower Limit
- 11.07
- upper Limit
- NA
- value
- 21.13
- comment
- Median, lower and upper limit of confidence interval could not be calculated because no participant had an event.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG002
- lower Limit
- 6.60
- upper Limit
- 22.67
- value
- 8.31
- group Id
- OG003
- lower Limit
- 2.83
- upper Limit
- 8.34
- value
- 4.14
- comment
- Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
- group Id
- OG004
- lower Limit
- 4.04
- upper Limit
- NA
- value
- 22.23
- comment
- Median, lower and upper limit of confidence interval could not be calculated because no participant had an event.
- group Id
- OG007
- 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 derive.
- group Id
- OG008
- lower Limit
- 2.63
- upper Limit
- NA
- value
- NA
- comment
- Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
- group Id
- OG009
- lower Limit
- 11.07
- upper Limit
- NA
- value
- 15.21
- comment
- As per planned analysis, data was analyzed in form of graph and no descriptive analysis was performed.
- group Id
- OG010
- 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 derive.
- group Id
- OG011
- lower Limit
- 4.24
- upper Limit
- NA
- value
- NA
- comment
- Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
- group Id
- OG012
- lower Limit
- 2.79
- upper Limit
- NA
- value
- 10.61
- comment
- Due to small number of events, estimates (median and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
- group Id
- OG013
- lower Limit
- 6.93
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 35
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 11
- group Id
- OG009
- value
- 5
- group Id
- OG010
- value
- 7
- group Id
- OG011
- value
- 16
- 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 non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG000
- title
- Primary Expansion Cohort: NSCLC, Post-platinum Doublet
- description
- Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG001
- title
- Primary Expansion Cohort: NSCLC, First Line
- description
- Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG002
- title
- Primary Expansion Cohort: Metastatic Breast Cancer
- description
- Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG003
- title
- Primary Expansion Cohort: GC/GEJC Progressed
- description
- Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG004
- title
- Primary Expansion Cohort: GC/GEJC Non Progressed
- description
- Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG005
- title
- Secondary Expansion Cohort: Colorectal Cancer
- description
- Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG006
- title
- Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
- description
- Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG007
- title
- Secondary Expansion Cohort: Adrenocortical Carcinoma
- description
- Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG008
- title
- Secondary Expansion Cohort: Melanoma
- description
- Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG009
- title
- Secondary Expansion Cohort: Mesothelioma
- description
- Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG010
- title
- Secondary Expansion Cohort: Urothelial Carcinoma
- description
- Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG011
- title
- Secondary Expansion Cohort: Ovarian Cancer
- param Type
- MEDIAN
- population Description
- FAS included all participants who have received at least 1 dose of study treatment. Data for this outcome measure is reported for the participants with Complete or Partial response.
- reporting Status
- POSTED
- time Frame
- Dose Expansion: Baseline up to Day 2023
- title
- Dose Expansion Cohort: Duration of Response According to Modified Immune-Related Response Criteria (irRC) Per Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice