TriangleNCT03914612 · OUTCOME
Progression-free Survival (PFS)
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
- Duration of time from study entry to time of progression per RECIST criteria or death due to any cause, whichever occurs first. The interquartile range for follow-up was (6.37 months, 30.62 months). The maximum for follow-up was 37.85 months.
What was measured
Progression free survival (PFS) Note: For arm 2 (dMMR Cohort), the point estimate and the upper limit of the confidence interval are not able to be estimated due to insufficient events.
Analysis population: Randomized population (with determinate MMR status)
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) | 113 |
| (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 112 |
| (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 295 |
| (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 293 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 7.6 | Not reported | 6.4 | 9.9 | Not reported |
| (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | NA | Not reported | 30.6 | NA | The point estimate and the upper limit of the confidence interval are not able to be estimated due to insufficient events. |
| (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 8.7 | Not reported | 8.4 | 10.7 | Not reported |
| (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 11.7 | Not reported | 11.0 | 15.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.4
- upper Limit
- 9.9
- value
- 7.6
- comment
- The point estimate and the upper limit of the confidence interval are not able to be estimated due to insufficient events.
- group Id
- OG001
- lower Limit
- 30.6
- upper Limit
- NA
- value
- NA
- group Id
- OG002
- lower Limit
- 8.4
- upper Limit
- 10.7
- value
- 8.7
- group Id
- OG003
- lower Limit
- 11.0
- upper Limit
- 15.0
- value
- 11.7
- denoms
- counts
- group Id
- OG000
- value
- 113
- group Id
- OG001
- value
- 112
- group Id
- OG002
- value
- 295
- group Id
- OG003
- value
- 293
- units
- Participants
- description
- Progression free survival (PFS) Note: For arm 2 (dMMR Cohort), the point estimate and the upper limit of the confidence interval are not able to be estimated due to insufficient 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 population (with determinate MMR status)
- reporting Status
- POSTED
- time Frame
- Duration of time from study entry to time of progression per RECIST criteria or death due to any cause, whichever occurs first. The interquartile range for follow-up was (6.37 months, 30.62 months). The maximum for follow-up was 37.85 months.
- title
- Progression-free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice