TriangleNCT02555657 · OUTCOME
Duration of Response Per RECIST 1.1 in All Participants Who Had a Confirmed Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019)
What was measured
For participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, Duration of Response (DOR) was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR.
Analysis population: All randomized participants, regardless of whether or not they received study treatment, who demonstrated a confirmed response (CR or PR). Participants were included in the treatment arm to which they were randomized.
Groups in this outcome
Pembrolizumab
Participants received pembrolizumab 200 mg IV every Q3W for up to 35 administrations (up to \~2 years).
Chemotherapy
Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines.
| Group | Source count |
|---|---|
| Pembrolizumab | 30 |
| Chemotherapy | 33 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab | 12.2 | Not reported | 2.2 | NA | NA=DOR upper limit not reached at time of data cutoff due to insufficient number of responding participants with relapse |
| Chemotherapy | NA | Not reported | NA | NA | NA=Median DOR not reached at time of data cutoff due to insufficient number of responding participants with relapse NA=DOR lower limit not reached at time of data cutoff due to insufficient number of responding participants with relapse NA=DOR upper limit not reached at time of data cutoff due to insufficient number of responding participants with relapse |
Complete source fields
- classes
- categories
- measurements
- comment
- NA=DOR upper limit not reached at time of data cutoff due to insufficient number of responding participants with relapse
- group Id
- OG000
- lower Limit
- 2.2
- upper Limit
- NA
- value
- 12.2
- comment
- NA=Median DOR not reached at time of data cutoff due to insufficient number of responding participants with relapse NA=DOR lower limit not reached at time of data cutoff due to insufficient number of responding participants with relapse NA=DOR upper limit not reached at time of data cutoff due to insufficient number of responding participants with relapse
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 33
- units
- Participants
- description
- For participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, Duration of Response (DOR) was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR.
- dispersion Type
- Full Range
- groups
- description
- Participants received pembrolizumab 200 mg IV every Q3W for up to 35 administrations (up to \~2 years).
- id
- OG000
- title
- Pembrolizumab
- description
- Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines.
- id
- OG001
- title
- Chemotherapy
- param Type
- MEDIAN
- population Description
- All randomized participants, regardless of whether or not they received study treatment, who demonstrated a confirmed response (CR or PR). Participants were included in the treatment arm to which they were randomized.
- reporting Status
- POSTED
- time Frame
- Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019)
- title
- Duration of Response Per RECIST 1.1 in All Participants Who Had a Confirmed Response
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice