TriangleNCT01772004 · OUTCOME
Dose Expansion Cohort: Immune Related Progression-Free Survival (irPFS) Time According to Modified Immune-Related Response Criteria (irRC)
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
The irPFS time was defined as the time from first administration of study treatment until first documentation of immune-related progressive disease (irPD) or death when death occurred within 12 weeks of the last tumor assessment or first administration of study treatment (whichever was later). irPD: sum of the longest diameters of target and new measurable lesions increases greater than or equal to \[\>=\] 20%, confirmed by a repeat, consecutive observations at least 4 weeks from the date first documented. The analysis of irPFS will be performed with a Kaplan-Meier method. Data for immune related progression-free survival time has been reported.
Analysis population: FAS included all participants who have received at least 1 dose of study treatment. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
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 | 184 |
| Primary Expansion Cohort: NSCLC, First Line | 156 |
| Primary Expansion Cohort: Metastatic Breast Cancer | 168 |
| Primary Expansion Cohort: GC/GEJC Progressed | 60 |
| Primary Expansion Cohort: GC/GEJC Non Progressed | 90 |
| Secondary Expansion Cohort: Colorectal Cancer | 21 |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 18 |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 50 |
| Secondary Expansion Cohort: Melanoma | 51 |
| Secondary Expansion Cohort: Mesothelioma | 53 |
| Secondary Expansion Cohort: Urothelial Carcinoma | 44 |
| Secondary Expansion Cohort: Ovarian Cancer | 125 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 62 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 20 |
| Efficacy Expansion Cohort: Ovarian Cancer | 103 |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 198 |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 132 |
| Efficacy Expansion Cohort: HNSCC | 153 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 4.04 | Not reported | 2.76 | 5.49 | Not reported |
| Primary Expansion Cohort: NSCLC, First Line | 6.93 | Not reported | 5.42 | 9.69 | Not reported |
| Primary Expansion Cohort: Metastatic Breast Cancer | 1.64 | Not reported | 1.38 | 2.50 | Not reported |
| Primary Expansion Cohort: GC/GEJC Progressed | 1.81 | Not reported | 1.35 | 2.53 | Not reported |
| Primary Expansion Cohort: GC/GEJC Non Progressed | 4.14 | Not reported | 2.76 | 5.95 | Not reported |
| Secondary Expansion Cohort: Colorectal Cancer | 2.79 | Not reported | 1.41 | 5.82 | Not reported |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | NA | Not reported | 1.38 | 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: Adrenocortical Carcinoma | 3.81 | Not reported | 2.40 | 5.49 | Not reported |
| Secondary Expansion Cohort: Melanoma | 6.83 | Not reported | 2.79 | 11.04 | Not reported |
| Secondary Expansion Cohort: Mesothelioma | 6.18 | Not reported | 3.94 | 12.45 | Not reported |
| Secondary Expansion Cohort: Urothelial Carcinoma | 4.07 | Not reported | 2.63 | 9.46 | Not reported |
| Secondary Expansion Cohort: Ovarian Cancer | 4.04 | Not reported | 2.69 | 5.42 | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 8.34 | Not reported | 5.98 | 13.04 | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 6.90 | Not reported | 2.69 | 11.24 | Not reported |
| Efficacy Expansion Cohort: Ovarian Cancer | 2.60 | Not reported | 1.51 | 3.84 | Not reported |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 2.46 | Not reported | 1.48 | 2.76 | Not reported |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 1.35 | Not reported | 1.31 | 1.41 | Not reported |
| Efficacy Expansion Cohort: HNSCC | 2.83 | Not reported | 2.66 | 4.14 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.76
- upper Limit
- 5.49
- value
- 4.04
- group Id
- OG001
- lower Limit
- 5.42
- upper Limit
- 9.69
- value
- 6.93
- group Id
- OG002
- lower Limit
- 1.38
- upper Limit
- 2.50
- value
- 1.64
- group Id
- OG003
- lower Limit
- 1.35
- upper Limit
- 2.53
- value
- 1.81
- group Id
- OG004
- lower Limit
- 2.76
- upper Limit
- 5.95
- value
- 4.14
- group Id
- OG005
- lower Limit
- 1.41
- upper Limit
- 5.82
- value
- 2.79
- 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
- OG006
- lower Limit
- 1.38
- upper Limit
- NA
- value
- NA
- group Id
- OG007
- lower Limit
- 2.40
- upper Limit
- 5.49
- value
- 3.81
- group Id
- OG008
- lower Limit
- 2.79
- upper Limit
- 11.04
- value
- 6.83
- group Id
- OG009
- lower Limit
- 3.94
- upper Limit
- 12.45
- value
- 6.18
- group Id
- OG010
- lower Limit
- 2.63
- upper Limit
- 9.46
- value
- 4.07
- group Id
- OG011
- lower Limit
- 2.69
- upper Limit
- 5.42
- value
- 4.04
- denoms
- counts
- group Id
- OG000
- value
- 184
- group Id
- OG001
- value
- 156
- group Id
- OG002
- value
- 168
- group Id
- OG003
- value
- 60
- group Id
- OG004
- value
- 90
- group Id
- OG005
- value
- 21
- group Id
- OG006
- value
- 18
- group Id
- OG007
- value
- 50
- group Id
- OG008
- value
- 51
- group Id
- OG009
- value
- 53
- group Id
- OG010
- value
- 44
- group Id
- OG011
- value
- 125
- units
- Participants
- description
- The irPFS time was defined as the time from first administration of study treatment until first documentation of immune-related progressive disease (irPD) or death when death occurred within 12 weeks of the last tumor assessment or first administration of study treatment (whichever was later). irPD: sum of the longest diameters of target and new measurable lesions increases greater than or equal to \[\>=\] 20%, confirmed by a repeat, consecutive observations at least 4 weeks from the date first documented. The analysis of irPFS will be performed with a Kaplan-Meier method. Data for immune related progression-free survival time has been reported.
- 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. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Dose Expansion: Baseline up to Day 2023
- title
- Dose Expansion Cohort: Immune Related Progression-Free Survival (irPFS) Time According to Modified Immune-Related Response Criteria (irRC)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice