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← Carcinosarcoma

NCT03914612 · STUDY IN CONTEXT

Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Randomized population (with determinate MMR status)

→

secondary · POSTED

Assessed by Common Terminology Criteria for Adverse Events (CTCAE V5.0). The endpoint is the count of participants with an adverse event of grade 3 (or higher) by treatment group.

All randomized patients

→

secondary · POSTED

Assessed by Response Evaluation Criteria for Solid Tumors (RECIST) 1.1.

Randomized patients with measurable disease

→

secondary · POSTED

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.

Randomized patients with objective tumor response

→

secondary · NOT_POSTED

Overall Survival (OS). This endpoint will be assessed by Kaplan-Meier.

Source null

→

secondary · POSTED

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.

The pMMR patients who provided baseline and at least one follow-up QOL assessment.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Quality of Life (QoL) in pMMR Patients Only

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-carcinosarcoma
nct id
NCT03914612
qol key
qol-0005
source section id
NCT03914612-om-0005
source outcome index
5
instrument
FACT
instrument basis
matched 'fact' in the study's own wording
scale title
Quality of Life (QoL) in pMMR Patients Only
measure definition
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.
time frame
0-54 weeks from start of treatment
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The pMMR patients who provided baseline and at least one follow-up QOL assessment.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Incidence of Pembrolizumab Treatment and Self-reported Neurotoxicity

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-carcinosarcoma
nct id
NCT03914612
qol key
qol-0007
source section id
NCT03914612-om-0007
source outcome index
7
instrument
FACT
instrument basis
matched 'fact' in the study's own wording
scale title
Incidence of Pembrolizumab Treatment and Self-reported Neurotoxicity
measure definition
Patient-reported neurotoxicity will be measured with FACT/GOG-Ntx subscale (short form).
time frame
0-54 weeks from start of treatment
analysis role
exploratory
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-carcinosarcoma
nct id
NCT03914612
trial label
Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
4
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    outcome key
    om-0000
    source section id
    NCT03914612-om-0000
    source outcome index
    0
    endpoint
    Progression-free Survival (PFS)
    endpoint definition
    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.
    time origin
    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.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Randomized population (with determinate MMR status)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    outcome key
    om-0001
    source section id
    NCT03914612-om-0001
    source outcome index
    1
    endpoint
    Adverse Events With Grade 3 (or Higher)
    endpoint definition
    Assessed by Common Terminology Criteria for Adverse Events (CTCAE V5.0). The endpoint is the count of participants with an adverse event of grade 3 (or higher) by treatment group.
    time origin
    For the adverse event time frame, the interquartile range was (0.79 months, 3.42 months); the maximum was 28.39 months.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized patients
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    outcome key
    om-0002
    source section id
    NCT03914612-om-0002
    source outcome index
    2
    endpoint
    Objective Tumor Response
    endpoint definition
    Assessed by Response Evaluation Criteria for Solid Tumors (RECIST) 1.1.
    time origin
    For the time frame for tumor response, the interquartile range was (2.27 months, 8.66 months) and the maximum was 36.37 months.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Randomized patients with measurable disease
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    outcome key
    om-0003
    source section id
    NCT03914612-om-0003
    source outcome index
    3
    endpoint
    Duration of Objective Response
    endpoint definition
    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.
    time origin
    For the duration of objective response, the interquartile range is (4.24 months, 7.92 months); the maximum is 28.68 months.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Randomized patients with objective tumor response
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    outcome key
    om-0004
    source section id
    NCT03914612-om-0004
    source outcome index
    4
    endpoint
    Overall Survival (OS)
    endpoint definition
    Overall Survival (OS). This endpoint will be assessed by Kaplan-Meier.
    time origin
    Time from study entry to time of death or the date of last contact, assessed up to 5 years
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    outcome key
    om-0005
    source section id
    NCT03914612-om-0005
    source outcome index
    5
    endpoint
    Quality of Life (QoL) in pMMR Patients Only
    endpoint definition
    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.
    time origin
    0-54 weeks from start of treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The pMMR patients who provided baseline and at least one follow-up QOL assessment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    outcome key
    om-0000
    arm key
    OG000
    arm label
    (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin)
    regimen
    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.
    analyzed count
    113
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03914612-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    outcome key
    om-0000
    arm key
    OG001
    arm label
    (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)
    regimen
    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.
    analyzed count
    112
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03914612-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    outcome key
    om-0000
    arm key
    OG002
    arm label
    (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin)
    regimen
    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.
    analyzed count
    295
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03914612-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    outcome key
    om-0000
    arm key
    OG003
    arm label
    (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)
    regimen
    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.
    analyzed count
    293
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03914612-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    outcome key
    om-0001
    arm key
    OG000
    arm label
    (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin)
    regimen
    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.
    analyzed count
    106
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03914612-om-0001#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    outcome key
    om-0001
    arm key
    OG001
    arm label
    (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)
    regimen
    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.
    analyzed count
    109
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03914612-om-0001#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    outcome key
    om-0001
    arm key
    OG002
    arm label
    (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin)
    regimen
    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.
    analyzed count
    274
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03914612-om-0001#groups/OG002
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    outcome key
    om-0001
    arm key
    OG003
    arm label
    (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)
    regimen
    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.
    analyzed count
    276
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03914612-om-0001#groups/OG003
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    outcome key
    om-0002
    arm key
    OG000
    arm label
    (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin)
    regimen
    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.
    analyzed count
    92
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03914612-om-0002#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    outcome key
    om-0002
    arm key
    OG001
    arm label
    (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)
    regimen
    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.
    analyzed count
    92
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03914612-om-0002#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    outcome key
    om-0002
    arm key
    OG002
    arm label
    (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin)
    regimen
    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.
    analyzed count
    234
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03914612-om-0002#groups/OG002
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    outcome key
    om-0002
    arm key
    OG003
    arm label
    (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)
    regimen
    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.
    analyzed count
    212
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03914612-om-0002#groups/OG003
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    harm key
    EG000
    source section id
    NCT03914612-ae
    event group key
    EG000
    event group label
    (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin)
    serious affected
    50
    serious at risk
    106
    other affected
    105
    other at risk
    106
    frequency threshold
    0
    collection period
    Adverse Events monitored/assessed up to 28.39 months; the interquartile range was (0.79 months, 3.42 months). All-Cause Mortality monitored/assessed up to 37.85 months; the interquartile range was (6.37 months, 30.62 months).
    event definition
    Assessed by Common Terminology Criteria for Adverse Events (CTCAE). All Enrolled participants monitored/assessed for All-Cause Mortality; participants that received intervention (safety population) monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    harm key
    EG001
    source section id
    NCT03914612-ae
    event group key
    EG001
    event group label
    (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)
    serious affected
    66
    serious at risk
    109
    other affected
    107
    other at risk
    109
    frequency threshold
    0
    collection period
    Adverse Events monitored/assessed up to 28.39 months; the interquartile range was (0.79 months, 3.42 months). All-Cause Mortality monitored/assessed up to 37.85 months; the interquartile range was (6.37 months, 30.62 months).
    event definition
    Assessed by Common Terminology Criteria for Adverse Events (CTCAE). All Enrolled participants monitored/assessed for All-Cause Mortality; participants that received intervention (safety population) monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    harm key
    EG002
    source section id
    NCT03914612-ae
    event group key
    EG002
    event group label
    (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin)
    serious affected
    125
    serious at risk
    274
    other affected
    256
    other at risk
    274
    frequency threshold
    0
    collection period
    Adverse Events monitored/assessed up to 28.39 months; the interquartile range was (0.79 months, 3.42 months). All-Cause Mortality monitored/assessed up to 37.85 months; the interquartile range was (6.37 months, 30.62 months).
    event definition
    Assessed by Common Terminology Criteria for Adverse Events (CTCAE). All Enrolled participants monitored/assessed for All-Cause Mortality; participants that received intervention (safety population) monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    harm key
    EG003
    source section id
    NCT03914612-ae
    event group key
    EG003
    event group label
    (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)
    serious affected
    152
    serious at risk
    276
    other affected
    258
    other at risk
    276
    frequency threshold
    0
    collection period
    Adverse Events monitored/assessed up to 28.39 months; the interquartile range was (0.79 months, 3.42 months). All-Cause Mortality monitored/assessed up to 37.85 months; the interquartile range was (6.37 months, 30.62 months).
    event definition
    Assessed by Common Terminology Criteria for Adverse Events (CTCAE). All Enrolled participants monitored/assessed for All-Cause Mortality; participants that received intervention (safety population) monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    qol key
    qol-0005
    source section id
    NCT03914612-om-0005
    source outcome index
    5
    instrument
    FACT
    instrument basis
    matched 'fact' in the study's own wording
    scale title
    Quality of Life (QoL) in pMMR Patients Only
    measure definition
    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.
    time frame
    0-54 weeks from start of treatment
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    The pMMR patients who provided baseline and at least one follow-up QOL assessment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-carcinosarcoma
    nct id
    NCT03914612
    qol key
    qol-0007
    source section id
    NCT03914612-om-0007
    source outcome index
    7
    instrument
    FACT
    instrument basis
    matched 'fact' in the study's own wording
    scale title
    Incidence of Pembrolizumab Treatment and Self-reported Neurotoxicity
    measure definition
    Patient-reported neurotoxicity will be measured with FACT/GOG-Ntx subscale (short form).
    time frame
    0-54 weeks from start of treatment
    analysis role
    exploratory
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice