TriangleNCT01772004 · OUTCOME
Dose Escalation Cohort: Number of Participants With Best Overall Response (BOR) 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
- Dose Escalation: Baseline up to Day 2511
What was measured
BOR was determined according to RECIST v1.1 and as per investigator assessment. BOR is defined as the best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression or recurrence (taking the smallest measurement recorded since start of treatment as reference). 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. SD =Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.
Analysis population: Safety analysis set included all participants who have received at least 1 dose of study treatment.
Groups in this outcome
Dose Escalation Cohort: Avelumab 1.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
Dose Escalation Cohort: Avelumab 3.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Dose Escalation Cohort: Avelumab 10.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Dose Escalation Cohort: Avelumab 20.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
| Group | Source count |
|---|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 4 |
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 13 |
| Dose Escalation Cohort: Avelumab 10.0 mg/kg | 15 |
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 21 |
| Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly | 8 |
Reported measurements
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 10.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly | 0 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 10.0 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly | 1 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 8 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 10.0 mg/kg | 8 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 14 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly | 4 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 10.0 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly | 1 | Not reported | Not reported | Not reported | Not reported |
Not Evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 10.0 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 14
- group Id
- OG004
- value
- 4
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 1
- title
- Progressive Disease
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- title
- Not Evaluable
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 21
- group Id
- OG004
- value
- 8
- units
- Participants
- description
- BOR was determined according to RECIST v1.1 and as per investigator assessment. BOR is defined as the best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression or recurrence (taking the smallest measurement recorded since start of treatment as reference). 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. SD =Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.
- groups
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
- id
- OG000
- title
- Dose Escalation Cohort: Avelumab 1.0 mg/kg
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG001
- title
- Dose Escalation Cohort: Avelumab 3.0 mg/kg
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG002
- title
- Dose Escalation Cohort: Avelumab 10.0 mg/kg
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG003
- title
- Dose Escalation Cohort: Avelumab 20.0 mg/kg
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG004
- title
- Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set included all participants who have received at least 1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Dose Escalation: Baseline up to Day 2511
- title
- Dose Escalation Cohort: Number of Participants With Best Overall Response (BOR) 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