TriangleNCT01675765 · STUDY IN CONTEXT
Safety and Efficacy of Listeria in Combination With Chemotherapy as Front-line Treatment for Malignant Pleural Mesothelioma
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 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
Count of subjects with incidences of adverse events.
Induction of Immune Response to Mesothelin by Enzyme-linked Immunosorbent Spot (ELISPOT) Assay
Objective tumor response was measured using modified Response Evaluation Criteria in Solid Tumors (mRECIST) for assessment of response in malignant pleural mesothelioma (MPM). Per mRECIST for target lesions and assessed by CT: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease, those who fulfilled the criteria for neither PR nor PD; Progressive Disease (PD), \>=20% increase in the sum of the longest diameter of target lesions.
Time to Progression
Serum Mesothelin as Correlate of Therapeutic Response
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-mesothelioma
- nct id
- NCT01675765
- trial label
- Safety and Efficacy of Listeria in Combination With Chemotherapy as Front-line Treatment for Malignant Pleural Mesothelioma
- 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
- 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
- 5
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01675765
- outcome key
- om-0000
- source section id
- NCT01675765-om-0000
- source outcome index
- 0
- endpoint
- Number of Subjects Reporting Adverse Events
- endpoint definition
- Count of subjects with incidences of adverse events.
- time origin
- From first study dose until 28 days after the final dose (an average of 44 weeks)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety Analysis Set (all participants who received \>= 1 dose of study treatment)
- 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-mesothelioma
- nct id
- NCT01675765
- outcome key
- om-0001
- source section id
- NCT01675765-om-0001
- source outcome index
- 1
- endpoint
- Induction of Immune Response to Mesothelin by Enzyme-linked Immunosorbent Spot (ELISPOT) Assay
- endpoint definition
- Induction of Immune Response to Mesothelin by Enzyme-linked Immunosorbent Spot (ELISPOT) Assay
- time origin
- Change over time assessed at multiple time points until disease progression or death (up to 12 months or longer)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Immune response to mesothelin was not assessed.
- 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-mesothelioma
- nct id
- NCT01675765
- outcome key
- om-0002
- source section id
- NCT01675765-om-0002
- source outcome index
- 2
- endpoint
- Objective Tumor Response
- endpoint definition
- Objective tumor response was measured using modified Response Evaluation Criteria in Solid Tumors (mRECIST) for assessment of response in malignant pleural mesothelioma (MPM). Per mRECIST for target lesions and assessed by CT: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease, those who fulfilled the criteria for neither PR nor PD; Progressive Disease (PD), \>=20% increase in the sum of the longest diameter of target lesions.
- time origin
- Baseline to measured disease progression or death (up to 12 months or longer)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety analysis set: all enrolled subjects who received at least one dose of study treatment and had measurable disease.
- 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-mesothelioma
- nct id
- NCT01675765
- outcome key
- om-0003
- source section id
- NCT01675765-om-0003
- source outcome index
- 3
- endpoint
- Time to Progression
- endpoint definition
- Time to Progression
- time origin
- From date of randomization until date of documented progression (by modified RECIST or immune-related response criteria) or death, assessed up to 12 months or longer
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Time to progression was not assessed.
- 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-mesothelioma
- nct id
- NCT01675765
- outcome key
- om-0004
- source section id
- NCT01675765-om-0004
- source outcome index
- 4
- endpoint
- Serum Mesothelin as Correlate of Therapeutic Response
- endpoint definition
- Serum Mesothelin as Correlate of Therapeutic Response
- time origin
- Change over time assessed at multiple time points until disease progression or death (up to 12 months or longer)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Predictive value of serum mesothelin was not assessed.
- 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-mesothelioma
- nct id
- NCT01675765
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Immunotherapy Plus Chemotherapy
- regimen
- Weeks 1 and 3: CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: CRS-207 Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy plus chemotherapy: live attenuated double deleted Lm
- analyzed count
- 38
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01675765-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01675765
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Immunotherapy With Cyclophosphamide Plus Chemotherapy
- regimen
- Weeks 1 and 3: cyclophosphamide (200 mg/m\^2), CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: cyclophosphamide one day before CRS-207 Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm
- analyzed count
- 22
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01675765-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01675765
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Immunotherapy Plus Chemotherapy
- regimen
- Weeks 1 and 3: CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: CRS-207 Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy plus chemotherapy: live attenuated double deleted Lm
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01675765-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01675765
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Immunotherapy With Cyclophosphamide Plus Chemotherapy
- regimen
- Weeks 1 and 3: cyclophosphamide (200 mg/m\^2), CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: cyclophosphamide one day before CRS-207 Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01675765-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01675765
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Immunotherapy Plus Chemotherapy
- regimen
- Weeks 1 and 3: CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: CRS-207 Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy plus chemotherapy: live attenuated double deleted Lm
- analyzed count
- 36
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01675765-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01675765
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Immunotherapy With Cyclophosphamide Plus Chemotherapy
- regimen
- Weeks 1 and 3: cyclophosphamide (200 mg/m\^2), CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: cyclophosphamide one day before CRS-207 Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01675765-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01675765
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Immunotherapy Plus Chemotherapy
- regimen
- Weeks 1 and 3: CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: CRS-207 Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy plus chemotherapy: live attenuated double deleted Lm
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01675765-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01675765
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Immunotherapy With Cyclophosphamide Plus Chemotherapy
- regimen
- Weeks 1 and 3: cyclophosphamide (200 mg/m\^2), CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: cyclophosphamide one day before CRS-207 Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01675765-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01675765
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Immunotherapy Plus Chemotherapy
- regimen
- Weeks 1 and 3: CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: CRS-207 Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy plus chemotherapy: live attenuated double deleted Lm
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01675765-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01675765
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Immunotherapy With Cyclophosphamide Plus Chemotherapy
- regimen
- Weeks 1 and 3: cyclophosphamide (200 mg/m\^2), CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: cyclophosphamide one day before CRS-207 Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01675765-om-0004#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01675765
- harm key
- EG000
- source section id
- NCT01675765-ae
- event group key
- EG000
- event group label
- Immunotherapy Plus Chemotherapy
- serious affected
- 15
- serious at risk
- 38
- other affected
- 38
- other at risk
- 38
- frequency threshold
- 5
- collection period
- From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 5 years from the date of randomization.
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01675765
- harm key
- EG001
- source section id
- NCT01675765-ae
- event group key
- EG001
- event group label
- Immunotherapy With Cyclophosphamide Plus Chemotherapy
- serious affected
- 11
- serious at risk
- 22
- other affected
- 22
- other at risk
- 22
- frequency threshold
- 5
- collection period
- From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 5 years from the date of randomization.
- 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