TriangleNCT02256436 · OUTCOME
DOR Per RECIST 1.1 - Participants With PD-L1 Positive Tumors
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Through final analysis database cut-off date of 26-Oct-2017 (Up to approximately 34 months)
What was measured
For participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. Per protocol, the DOR was to be censored at the date of the last tumor assessment for participants who had progressed or died after 2 or more missed visits, who had started a new anti-cancer treatment, who were lost to follow-up, or who had an ongoing response. DOR was assessed in all participants who had PD-L1 positive tumors (CPS ≥1%) based on BICR and was analyzed using the Kaplan-Meier method.
Analysis population: The analysis population consisted of all randomized PD-L1 positive participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.
Groups in this outcome
Control
Participants received paclitaxel 175 mg/m\^2 intravenously (IV) or docetaxel 75 mg/m\^2 IV or vinflunine 320 mg/m\^2 IV, on Day 1 of each 3-week cycle (Q3W). Eligible participants who experienced disease progression may have been able to switch over to receive pembrolizumab 200 mg IV Q3W for up to 35 treatment administrations (up to approximately 2 years).
Pembrolizumab
Participants received pembrolizumab 200 mg IV on Day 1 Q3W. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg IV Q3W for up to 17 cycles (up to approximately 1 additional year).
| Group | Source count |
|---|---|
| Control | 10 |
| Pembrolizumab | 25 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Control | NA | Not reported | 2.8 | NA | NA= Median DOR was not reached because there were not enough events, DOR upper 95% confidence limit was undefined because the DOR rate was not low enough at the time of the cut-off date. |
| Pembrolizumab | NA | Not reported | 21.8 | NA | NA= Median DOR was not reached because there were not enough events, DOR upper 95% confidence limit was undefined because the DOR rate was not low enough at the time of the cut-off date. |
Complete source fields
- classes
- categories
- measurements
- comment
- NA= Median DOR was not reached because there were not enough events, DOR upper 95% confidence limit was undefined because the DOR rate was not low enough at the time of the cut-off date.
- group Id
- OG000
- lower Limit
- 2.8
- upper Limit
- NA
- value
- NA
- comment
- NA= Median DOR was not reached because there were not enough events, DOR upper 95% confidence limit was undefined because the DOR rate was not low enough at the time of the cut-off date.
- group Id
- OG001
- lower Limit
- 21.8
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 25
- units
- Participants
- description
- For participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. Per protocol, the DOR was to be censored at the date of the last tumor assessment for participants who had progressed or died after 2 or more missed visits, who had started a new anti-cancer treatment, who were lost to follow-up, or who had an ongoing response. DOR was assessed in all participants who had PD-L1 positive tumors (CPS ≥1%) based on BICR and was analyzed using the Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received paclitaxel 175 mg/m\^2 intravenously (IV) or docetaxel 75 mg/m\^2 IV or vinflunine 320 mg/m\^2 IV, on Day 1 of each 3-week cycle (Q3W). Eligible participants who experienced disease progression may have been able to switch over to receive pembrolizumab 200 mg IV Q3W for up to 35 treatment administrations (up to approximately 2 years).
- id
- OG000
- title
- Control
- description
- Participants received pembrolizumab 200 mg IV on Day 1 Q3W. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg IV Q3W for up to 17 cycles (up to approximately 1 additional year).
- id
- OG001
- title
- Pembrolizumab
- param Type
- MEDIAN
- population Description
- The analysis population consisted of all randomized PD-L1 positive participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.
- reporting Status
- POSTED
- time Frame
- Through final analysis database cut-off date of 26-Oct-2017 (Up to approximately 34 months)
- title
- DOR Per RECIST 1.1 - Participants With PD-L1 Positive Tumors
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice