TriangleNCT02155647 · OUTCOME
Part B: Participant's Response Status According to RECIST 1.1 at 6 and 12 Months
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- Not reported
- Time frame
- At Month 6 and 12
What was measured
The response status at 6 and 12 months after start of trial treatment according to RECIST 1.1 (as determined by the IERC) was determined. A participant was considered to be in response at the given timepoint (6 or 12 months after the start of the participant's treatment) if the participant had a documented response (PR or CR) prior to that timepoint, and neither died nor experienced disease progression according to the RECIST 1.1 nor was lost to follow-up up to the given timepoint. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Percentage of participants in response and not in response according to RECIST1.1 at 6 and 12 months were reported.
Analysis population: Full Analysis Set included all participants who received at least 1 dose of study treatment.
Groups in this outcome
Part B: Avelumab
Participants received Avelumab as first-line treatment for metastatic or distally recurrent MCC at a dose of 10 mg/kg as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
| Group | Source count |
|---|---|
| Part B: Avelumab | 116 |
Reported measurements
In-response at Month 6
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B: Avelumab | 33.6 | Not reported | 25.1 | 43.0 | Not reported |
In-response at Month 12
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B: Avelumab | 26.7 | Not reported | 18.9 | 35.7 | Not reported |
Not in-response at Month 6
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B: Avelumab | 66.4 | Not reported | Not reported | Not reported | Not reported |
Not in-response at Month 12
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B: Avelumab | 73.3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 25.1
- upper Limit
- 43.0
- value
- 33.6
- title
- In-response at Month 6
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.9
- upper Limit
- 35.7
- value
- 26.7
- title
- In-response at Month 12
- categories
- measurements
- group Id
- OG000
- value
- 66.4
- title
- Not in-response at Month 6
- categories
- measurements
- group Id
- OG000
- value
- 73.3
- title
- Not in-response at Month 12
- denoms
- counts
- group Id
- OG000
- value
- 116
- units
- Participants
- description
- The response status at 6 and 12 months after start of trial treatment according to RECIST 1.1 (as determined by the IERC) was determined. A participant was considered to be in response at the given timepoint (6 or 12 months after the start of the participant's treatment) if the participant had a documented response (PR or CR) prior to that timepoint, and neither died nor experienced disease progression according to the RECIST 1.1 nor was lost to follow-up up to the given timepoint. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Percentage of participants in response and not in response according to RECIST1.1 at 6 and 12 months were reported.
- groups
- description
- Participants received Avelumab as first-line treatment for metastatic or distally recurrent MCC at a dose of 10 mg/kg as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
- id
- OG000
- title
- Part B: Avelumab
- param Type
- NUMBER
- population Description
- Full Analysis Set included all participants who received at least 1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- At Month 6 and 12
- title
- Part B: Participant's Response Status According to RECIST 1.1 at 6 and 12 Months
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice