TriangleNCT03914612 · OUTCOME
Duration of Objective 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
- 95% Confidence Interval
- Time frame
- For the duration of objective response, the interquartile range is (4.24 months, 7.92 months); the maximum is 28.68 months.
What was measured
The time difference between the dates of first response and first progression; patients who do not progress are considered censored. Note: for Arm 2 (dMMR Cohort), the upper limit of the confidence interval is not able to be estimated due to an insufficient number of events.
Analysis population: Randomized patients with objective tumor response
Groups in this outcome
(dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin)
COMBINATION PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
(dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)
COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
(pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin)
COMBINATION PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
(pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)
COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 65 |
| (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 75 |
| (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 136 |
| (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 150 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 6.2 | Not reported | 4.3 | 9.2 | Not reported |
| (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 28.7 | Not reported | 20.2 | NA | The upper limit of the confidence interval is not able to be estimated due to an insufficient number of events. |
| (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 6.2 | Not reported | 4.8 | 6.5 | Not reported |
| (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 9.2 | Not reported | 7.1 | 14.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.3
- upper Limit
- 9.2
- value
- 6.2
- comment
- The upper limit of the confidence interval is not able to be estimated due to an insufficient number of events.
- group Id
- OG001
- lower Limit
- 20.2
- upper Limit
- NA
- value
- 28.7
- group Id
- OG002
- lower Limit
- 4.8
- upper Limit
- 6.5
- value
- 6.2
- group Id
- OG003
- lower Limit
- 7.1
- upper Limit
- 14.7
- value
- 9.2
- denoms
- counts
- group Id
- OG000
- value
- 65
- group Id
- OG001
- value
- 75
- group Id
- OG002
- value
- 136
- group Id
- OG003
- value
- 150
- units
- Participants
- description
- The time difference between the dates of first response and first progression; patients who do not progress are considered censored. Note: for Arm 2 (dMMR Cohort), the upper limit of the confidence interval is not able to be estimated due to an insufficient number of events.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- COMBINATION PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin)
- description
- COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)
- description
- COMBINATION PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
- id
- OG002
- title
- (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin)
- description
- COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
- id
- OG003
- title
- (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)
- param Type
- MEDIAN
- population Description
- Randomized patients with objective tumor response
- reporting Status
- POSTED
- time Frame
- For the duration of objective response, the interquartile range is (4.24 months, 7.92 months); the maximum is 28.68 months.
- title
- Duration of Objective Response
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice