NCT03914612 · OUTCOME
Quality of Life (QoL) in pMMR Patients Only
Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer · Source last updated 2026-07-31
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score
- Interval / dispersion
- Standard Deviation
- Time frame
- 0-54 weeks from start of treatment
What was measured
QoL are collected in pMMR patients only and measured with the Function Assessment of Cancer Therapy -Endometrial Trial Outcome Index (FACT En-TOI). The FACT-En TOI scores range 0 - 120 with a larger score suggesting better or favorable state of QOL.
Analysis population: The pMMR patients who provided baseline and at least one follow-up QOL assessment.
Groups in this outcome
(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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 254 |
|---|
| (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 248 |
|---|
Reported measurements
Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 254 |
|---|
| (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 248 |
|---|
Values in score · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 94.5 | 18.0 | Not reported | Not reported | Not reported |
|---|
| (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 95.3 | 16.7 | Not reported | Not reported | Not reported |
|---|
6 weeks
Analysis denominator · Participants
| Group | Source count |
|---|
| (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 249 |
|---|
| (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 239 |
|---|
Values in score · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 94.1 | 15.1 | Not reported | Not reported | Not reported |
|---|
| (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 92.0 | 15.5 | Not reported | Not reported | Not reported |
|---|
18 weeks
Analysis denominator · Participants
| Group | Source count |
|---|
| (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 212 |
|---|
| (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 218 |
|---|
Values in score · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 93.4 | 15.5 | Not reported | Not reported | Not reported |
|---|
| (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 90.3 | 16.2 | Not reported | Not reported | Not reported |
|---|
30 weeks
Analysis denominator · Participants
| Group | Source count |
|---|
| (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 183 |
|---|
| (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 196 |
|---|
Values in score · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 95.7 | 16.6 | Not reported | Not reported | Not reported |
|---|
| (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 94.6 | 15.7 | Not reported | Not reported | Not reported |
|---|
54 weeks
Analysis denominator · Participants
| Group | Source count |
|---|
| (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 142 |
|---|
| (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 149 |
|---|
Values in score · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 93.5 | 18.2 | Not reported | Not reported | Not reported |
|---|
| (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 96.8 | 15.0 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 18.0
- value
- 94.5
- group Id
- OG001
- spread
- 16.7
- value
- 95.3
- denoms
- counts
- group Id
- OG000
- value
- 254
- group Id
- OG001
- value
- 248
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 15.1
- value
- 94.1
- group Id
- OG001
- spread
- 15.5
- value
- 92.0
- denoms
- counts
- group Id
- OG000
- value
- 249
- group Id
- OG001
- value
- 239
- units
- Participants
- title
- 6 weeks
- categories
- measurements
- group Id
- OG000
- spread
- 15.5
- value
- 93.4
- group Id
- OG001
- spread
- 16.2
- value
- 90.3
- denoms
- counts
- group Id
- OG000
- value
- 212
- group Id
- OG001
- value
- 218
- units
- Participants
- title
- 18 weeks
- categories
- measurements
- group Id
- OG000
- spread
- 16.6
- value
- 95.7
- group Id
- OG001
- spread
- 15.7
- value
- 94.6
- denoms
- counts
- group Id
- OG000
- value
- 183
- group Id
- OG001
- value
- 196
- units
- Participants
- title
- 30 weeks
- categories
- measurements
- group Id
- OG000
- spread
- 18.2
- value
- 93.5
- group Id
- OG001
- spread
- 15.0
- value
- 96.8
- denoms
- counts
- group Id
- OG000
- value
- 142
- group Id
- OG001
- value
- 149
- units
- Participants
- title
- 54 weeks
- denoms
- counts
- group Id
- OG000
- value
- 254
- group Id
- OG001
- value
- 248
- units
- Participants
- description
- QoL are collected in pMMR patients only and measured with the Function Assessment of Cancer Therapy -Endometrial Trial Outcome Index (FACT En-TOI). The FACT-En TOI scores range 0 - 120 with a larger score suggesting better or favorable state of QOL.
- dispersion Type
- Standard Deviation
- 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
- (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
- OG001
- title
- (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)
- param Type
- MEAN
- population Description
- The pMMR patients who provided baseline and at least one follow-up QOL assessment.
- reporting Status
- POSTED
- time Frame
- 0-54 weeks from start of treatment
- title
- Quality of Life (QoL) in pMMR Patients Only
- type
- SECONDARY
- unit Of Measure
- score
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Preserved source evidence · Not medical advice
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