TriangleNCT01772004 · OUTCOME
Dose Expansion Cohort: Duration of Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 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 RECIST 1.1, per investigator assessment was calculated for each participant with a confirmed response (complete response \[CR\] or partial response \[PR\]) 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). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) 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 | 26 |
| Primary Expansion Cohort: NSCLC, First Line | 31 |
| Primary Expansion Cohort: Metastatic Breast Cancer | 5 |
| Primary Expansion Cohort: GC/GEJC Progressed | 4 |
| 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 | 6 |
| Secondary Expansion Cohort: Ovarian Cancer | 12 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 10 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 2 |
| Efficacy Expansion Cohort: Ovarian Cancer | 7 |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 31 |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 8 |
| Efficacy Expansion Cohort: HNSCC | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 17.48 | Not reported | 6.93 | 21.39 | Not reported |
| Primary Expansion Cohort: NSCLC, First Line | 12.02 | Not reported | 6.93 | 21.75 | Not reported |
| Primary Expansion Cohort: Metastatic Breast Cancer | 8.33 | Not reported | 6.60 | 22.67 | Not reported |
| Primary Expansion Cohort: GC/GEJC Progressed | 3.48 | Not reported | 2.76 | 8.34 | Not reported |
| Primary Expansion Cohort: GC/GEJC Non Progressed | 21.42 | 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 | 8.41 | Not reported | 6.80 | 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: 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 | 10.38 | Not reported | 4.17 | 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 (First Line) | 9.94 | 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 | 2.69 | 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: 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 | 8.31 | 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
- group Id
- OG000
- lower Limit
- 6.93
- upper Limit
- 21.39
- value
- 17.48
- group Id
- OG001
- lower Limit
- 6.93
- upper Limit
- 21.75
- value
- 12.02
- group Id
- OG002
- lower Limit
- 6.60
- upper Limit
- 22.67
- value
- 8.33
- group Id
- OG003
- lower Limit
- 2.76
- upper Limit
- 8.34
- value
- 3.48
- 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
- 21.42
- comment
- Due to small number of events, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
- group Id
- OG007
- lower Limit
- 6.80
- upper Limit
- NA
- value
- 8.41
- 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, estimate (upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.
- group Id
- OG011
- lower Limit
- 4.17
- upper Limit
- NA
- value
- 10.38
- 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
- 9.94
- 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
- 26
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 4
- 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
- 6
- group Id
- OG011
- value
- 12
- units
- Participants
- description
- Duration of response according to RECIST 1.1, per investigator assessment was calculated for each participant with a confirmed response (complete response \[CR\] or partial response \[PR\]) 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). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) 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 Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Per Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice