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← ALYMSYS: recurrent peritoneal cancer

NCT02399371 · STUDY IN CONTEXT

Pembrolizumab in Treating Patients With Malignant Mesothelioma

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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.

exploratory · POSTED

CD8 levels will be correlated with PD-L1 expression using Pearson or Spearman rank correlation coefficients.

Exploratory endpoint. Data not collected.

→

exploratory · POSTED

Other immune escape mechanisms including MDSCs and other checkpoints will be assessed by immunohistochemistry (0 - 3+) or flow cytometry counting the number and percentage of positive cells. Levels will be correlated with PD-L1 expression and other biomarkers.

Exploratory endpoint. Data not collected.

→

primary · POSTED

The Youden Index will be used to determine the optimal threshold for PD-L1 expression in correlation with tumor response. Youden Index ranges from 0-1 with higher scores meaning greater accuracy/sensitivity/specificity calculated from an ROC AUC (sensitivity + specificity - 1 = Youden Index).

Two patients had missing PD-L1 expression data.

→

secondary · POSTED

Kaplan-Meier curves will be generated for OS. Median OS will be estimated along with 95% confidence intervals using the method of Brookmeyer and Crowley.

Source null

→

secondary · POSTED

Kaplan-Meier curves will be generated for PFS. Median PFS will be estimated along with 95% confidence intervals using the method of Brookmeyer and Crowley.

Source null

→

secondary · POSTED

The disease control rate (CR+PR+SD) and 90% confidence interval will also be determined. Per Response Evaluation Criteria In Solid Tumors Criteria modified for immunotherapy (iRECIST) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), \>=120% increase in the sum of the longest diameter of target lesions; Stable disease (SD), not meeting criteria for either CR, PR, or PD. Per iRECIST, if criteria indicate PD, tumor assessment should be repeated 4 weeks later in order to confirm PD.

Source null

→

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

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm-alymsys-3743d6bc
nct id
NCT02399371
trial label
Pembrolizumab in Treating Patients With Malignant Mesothelioma
applicability
unclear
applicability note
Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-alymsys-3743d6bc
    nct id
    NCT02399371
    outcome key
    om-0004
    source section id
    NCT02399371-om-0004
    source outcome index
    4
    endpoint
    CD8 TILs Will be Assessed by Percentage of Tumor Showing Infiltration
    endpoint definition
    CD8 levels will be correlated with PD-L1 expression using Pearson or Spearman rank correlation coefficients.
    time origin
    Baseline
    analysis role
    exploratory
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Exploratory endpoint. Data not collected.
    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-malignant-peritoneal-neoplasm-alymsys-3743d6bc
    nct id
    NCT02399371
    outcome key
    om-0005
    source section id
    NCT02399371-om-0005
    source outcome index
    5
    endpoint
    Composite Measure of Other Immune Escape Mechanisms Including MDSCs and Other Checkpoints
    endpoint definition
    Other immune escape mechanisms including MDSCs and other checkpoints will be assessed by immunohistochemistry (0 - 3+) or flow cytometry counting the number and percentage of positive cells. Levels will be correlated with PD-L1 expression and other biomarkers.
    time origin
    Up to 5 years
    analysis role
    exploratory
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Exploratory endpoint. Data not collected.
    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-malignant-peritoneal-neoplasm-alymsys-3743d6bc
    nct id
    NCT02399371
    outcome key
    om-0000
    source section id
    NCT02399371-om-0000
    source outcome index
    0
    endpoint
    Ability of PD-L1 to Predict Response
    endpoint definition
    The Youden Index will be used to determine the optimal threshold for PD-L1 expression in correlation with tumor response. Youden Index ranges from 0-1 with higher scores meaning greater accuracy/sensitivity/specificity calculated from an ROC AUC (sensitivity + specificity - 1 = Youden Index).
    time origin
    Up to 1 year
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Two patients had missing PD-L1 expression data.
    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-malignant-peritoneal-neoplasm-alymsys-3743d6bc
    nct id
    NCT02399371
    outcome key
    om-0001
    source section id
    NCT02399371-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS)
    endpoint definition
    Kaplan-Meier curves will be generated for OS. Median OS will be estimated along with 95% confidence intervals using the method of Brookmeyer and Crowley.
    time origin
    Up to 5 years
    analysis role
    secondary
    reporting status
    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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-alymsys-3743d6bc
    nct id
    NCT02399371
    outcome key
    om-0002
    source section id
    NCT02399371-om-0002
    source outcome index
    2
    endpoint
    Progression Free Survival (PFS)
    endpoint definition
    Kaplan-Meier curves will be generated for PFS. Median PFS will be estimated along with 95% confidence intervals using the method of Brookmeyer and Crowley.
    time origin
    Time from enrollment until disease progression or death from any cause, assessed up to 5 years
    analysis role
    secondary
    reporting status
    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-malignant-peritoneal-neoplasm-alymsys-3743d6bc
    nct id
    NCT02399371
    outcome key
    om-0003
    source section id
    NCT02399371-om-0003
    source outcome index
    3
    endpoint
    Disease Control Rate (CR + PR + SD)
    endpoint definition
    The disease control rate (CR+PR+SD) and 90% confidence interval will also be determined. Per Response Evaluation Criteria In Solid Tumors Criteria modified for immunotherapy (iRECIST) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), \>=120% increase in the sum of the longest diameter of target lesions; Stable disease (SD), not meeting criteria for either CR, PR, or PD. Per iRECIST, if criteria indicate PD, tumor assessment should be repeated 4 weeks later in order to confirm PD.
    time origin
    Up to 1 year
    analysis role
    secondary
    reporting status
    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
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-alymsys-3743d6bc
    nct id
    NCT02399371
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Pembrolizumab)
    regimen
    Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients may be eligible for up to 1 year of additional pembrolizumab therapy if they progress after stopping pembrolizumab. Pembrolizumab: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacogenomic Study: Correlative studies
    analyzed count
    62
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02399371-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-alymsys-3743d6bc
    nct id
    NCT02399371
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Pembrolizumab)
    regimen
    Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients may be eligible for up to 1 year of additional pembrolizumab therapy if they progress after stopping pembrolizumab. Pembrolizumab: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacogenomic Study: Correlative studies
    analyzed count
    64
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02399371-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-alymsys-3743d6bc
    nct id
    NCT02399371
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (Pembrolizumab)
    regimen
    Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients may be eligible for up to 1 year of additional pembrolizumab therapy if they progress after stopping pembrolizumab. Pembrolizumab: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacogenomic Study: Correlative studies
    analyzed count
    64
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02399371-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-alymsys-3743d6bc
    nct id
    NCT02399371
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment (Pembrolizumab)
    regimen
    Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients may be eligible for up to 1 year of additional pembrolizumab therapy if they progress after stopping pembrolizumab. Pembrolizumab: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacogenomic Study: Correlative studies
    analyzed count
    64
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02399371-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-alymsys-3743d6bc
    nct id
    NCT02399371
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Treatment (Pembrolizumab)
    regimen
    Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients may be eligible for up to 1 year of additional pembrolizumab therapy if they progress after stopping pembrolizumab. Pembrolizumab: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacogenomic Study: Correlative studies
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02399371-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-alymsys-3743d6bc
    nct id
    NCT02399371
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Treatment (Pembrolizumab)
    regimen
    Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients may be eligible for up to 1 year of additional pembrolizumab therapy if they progress after stopping pembrolizumab. Pembrolizumab: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacogenomic Study: Correlative studies
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02399371-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-alymsys-3743d6bc
    nct id
    NCT02399371
    harm key
    EG000
    source section id
    NCT02399371-ae
    event group key
    EG000
    event group label
    Treatment (Pembrolizumab)
    serious affected
    25
    serious at risk
    64
    other affected
    64
    other at risk
    64
    frequency threshold
    5
    collection period
    Up to 30 days after completion of study treatment, maximum of 5 years.
    event definition
    Source null
    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
    setting source links

      Preserved source evidence · Not medical advice