TriangleNCT02399371 · 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
CD8 levels will be correlated with PD-L1 expression using Pearson or Spearman rank correlation coefficients.
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.
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).
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.
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.
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.
Reported safety
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-jobevne-224ef85f
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-jobevne-224ef85f
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-jobevne-224ef85f
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-jobevne-224ef85f
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-jobevne-224ef85f
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-jobevne-224ef85f
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-jobevne-224ef85f
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-jobevne-224ef85f
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-jobevne-224ef85f
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-jobevne-224ef85f
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-jobevne-224ef85f
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-jobevne-224ef85f
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-jobevne-224ef85f
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-jobevne-224ef85f
- 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