TriangleNCT01772004 · OUTCOME
Efficacy Expansion Cohorts: Progression-Free Survival (PFS) Time According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 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
The PFS time (based on IERC), according to the RECIST 1.1, was defined as the time from first administration of study treatment until first documentation of progressive disease (PD) or death when death occurred within 12 weeks of the last tumor assessment or first administration of study treatment (whichever was later). PD was defined as at least a 20% increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. The analysis of PFS was performed with a Kaplan-Meier method.
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 | 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 |
|---|---|---|---|---|---|
| Efficacy Expansion Cohort: Ovarian Cancer | 1.87 | Not reported | 1.41 | 2.66 | Not reported |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 1.45 | Not reported | 1.38 | 2.56 | Not reported |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 1.31 | Not reported | 1.28 | 1.38 | Not reported |
| Efficacy Expansion Cohort: HNSCC | 1.41 | Not reported | 1.38 | 2.63 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.41
- upper Limit
- 2.66
- value
- 1.87
- group Id
- OG001
- lower Limit
- 1.38
- upper Limit
- 2.56
- value
- 1.45
- group Id
- OG002
- lower Limit
- 1.28
- upper Limit
- 1.38
- value
- 1.31
- group Id
- OG003
- lower Limit
- 1.38
- upper Limit
- 2.63
- value
- 1.41
- denoms
- counts
- group Id
- OG000
- value
- 103
- group Id
- OG001
- value
- 198
- group Id
- OG002
- value
- 132
- group Id
- OG003
- value
- 153
- units
- Participants
- description
- The PFS time (based on IERC), according to the RECIST 1.1, was defined as the time from first administration of study treatment until first documentation of progressive disease (PD) or death when death occurred within 12 weeks of the last tumor assessment or first administration of study treatment (whichever was later). PD was defined as at least a 20% increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. The analysis of PFS was performed with a Kaplan-Meier method.
- 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: Progression-Free Survival (PFS) Time According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 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