TriangleNCT01772004 · OUTCOME
Primary Expansion Cohorts: Number of Participants With Unconfirmed Response at Week 13 According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Week 13
What was measured
The response criteria evaluation was carried out according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. CR and PR did not need to be confirmed by a subsequent tumor assessment due to blinded central assessment. CR: Disappearance of all target lesions since baseline; PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters; SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR and PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions. Number of participants with unconfirmed response at week 13 according to response evaluation criteria in solid tumors (RECIST) version 1.1 were reported.
Analysis population: Efficacy analysis set included all participants who have received at least 1 dose of study treatment and have measurable disease at baseline according to investigator assessment. This outcome measure was planned to be analyzed in Primary expansion cohorts only
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.
| 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 |
Reported measurements
Unconfirmed Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 2 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: NSCLC, First Line | 1 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: Metastatic Breast Cancer | 1 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: GC/GEJC Progressed | 0 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: GC/GEJC Non Progressed | 2 | Not reported | Not reported | Not reported | Not reported |
Unconfirmed Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 28 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: NSCLC, First Line | 24 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: Metastatic Breast Cancer | 7 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: GC/GEJC Progressed | 6 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: GC/GEJC Non Progressed | 5 | Not reported | Not reported | Not reported | Not reported |
Unconfirmed Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 62 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: NSCLC, First Line | 54 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: Metastatic Breast Cancer | 38 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: GC/GEJC Progressed | 11 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: GC/GEJC Non Progressed | 44 | Not reported | Not reported | Not reported | Not reported |
Unconfirmed Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 68 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: NSCLC, First Line | 28 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: Metastatic Breast Cancer | 107 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: GC/GEJC Progressed | 37 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: GC/GEJC Non Progressed | 31 | Not reported | Not reported | Not reported | Not reported |
Non-evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 24 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: NSCLC, First Line | 49 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: Metastatic Breast Cancer | 15 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: GC/GEJC Progressed | 6 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: GC/GEJC Non Progressed | 8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- title
- Unconfirmed Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 5
- title
- Unconfirmed Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 54
- group Id
- OG002
- value
- 38
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 44
- title
- Unconfirmed Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 68
- group Id
- OG001
- value
- 28
- group Id
- OG002
- value
- 107
- group Id
- OG003
- value
- 37
- group Id
- OG004
- value
- 31
- title
- Unconfirmed Progressive Disease
- categories
- measurements
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 49
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 8
- title
- Non-evaluable
- 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
- units
- Participants
- description
- The response criteria evaluation was carried out according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. CR and PR did not need to be confirmed by a subsequent tumor assessment due to blinded central assessment. CR: Disappearance of all target lesions since baseline; PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters; SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR and PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions. Number of participants with unconfirmed response at week 13 according to response evaluation criteria in solid tumors (RECIST) version 1.1 were reported.
- 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
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Efficacy analysis set included all participants who have received at least 1 dose of study treatment and have measurable disease at baseline according to investigator assessment. This outcome measure was planned to be analyzed in Primary expansion cohorts only
- reporting Status
- POSTED
- time Frame
- Week 13
- title
- Primary Expansion Cohorts: Number of Participants With Unconfirmed Response at Week 13 According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice