NCT04153565 · OUTCOME
Duration of Response (DOR)
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 31 months
What was measured
For participants who demonstrate a confirmed complete response (CR: disappearance of target and non-target lesions and normalization of tumor markers) or confirmed Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions), DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR was based on modified RECIST for MPM as assessed by investigator.
Analysis population: All participants who received at least 1 dose of study intervention and demonstrated a confirmed response (CR or PR)
Groups in this outcome
Pembrolizumab + Pemetrexed + Cisplatin
Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with pemetrexed 500 mg/m\^2 IV and cisplatin 75 mg/m\^2 IV for 4-6 cycles, followed by pembrolizumab 200 mg/m\^2 IV monotherapy Q3W for up to 35 cycles from the first dose of the study treatment (approximately 2 years). Each cycle was 21 days.
| Group | Source count |
|---|---|
| Pembrolizumab + Pemetrexed + Cisplatin | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + Pemetrexed + Cisplatin | 16.8 | Not reported | 3.0 | NA | 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
- 3.0
- upper Limit
- NA
- value
- 16.8
- denoms
- counts
- group Id
- OG000
- value
- 14
- units
- Participants
- description
- For participants who demonstrate a confirmed complete response (CR: disappearance of target and non-target lesions and normalization of tumor markers) or confirmed Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions), DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR was based on modified RECIST for MPM as assessed by investigator.
- dispersion Type
- Full Range
- groups
- description
- Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with pemetrexed 500 mg/m\^2 IV and cisplatin 75 mg/m\^2 IV for 4-6 cycles, followed by pembrolizumab 200 mg/m\^2 IV monotherapy Q3W for up to 35 cycles from the first dose of the study treatment (approximately 2 years). Each cycle was 21 days.
- id
- OG000
- title
- Pembrolizumab + Pemetrexed + Cisplatin
- param Type
- MEDIAN
- population Description
- All participants who received at least 1 dose of study intervention and demonstrated a confirmed response (CR or PR)
- reporting Status
- POSTED
- time Frame
- Up to approximately 31 months
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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