Safety and Efficacy of Listeria in Combination With Chemotherapy as Front-line Treatment for Malignant Pleural Mesothelioma
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ClinicalTrials.gov Identifier: NCT01675765 |
Recruitment Status :
Completed
First Posted : August 30, 2012
Results First Posted : September 30, 2020
Last Update Posted : September 30, 2020
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Malignant Pleural Mesothelioma |
Interventions |
Biological: Immunotherapy plus chemotherapy Biological: Immunotherapy with cyclophosphamide plus chemotherapy |
Enrollment | 60 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Immunotherapy Plus Chemotherapy | Immunotherapy With Cyclophosphamide Plus Chemotherapy |
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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 |
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 |
Period Title: Overall Study | ||
Started | 38 | 22 |
Completed | 27 | 14 |
Not Completed | 11 | 8 |
Reason Not Completed | ||
Progressive disease | 4 | 4 |
Adverse Event | 1 | 2 |
Withdrawal by Subject | 2 | 0 |
Death | 1 | 0 |
Clinical progression | 3 | 2 |
Arm/Group Title | Immunotherapy Plus Chemotherapy | Immunotherapy With Cyclophosphamide Plus Chemotherapy | Total | |
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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 |
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 |
Total of all reporting groups | |
Overall Number of Baseline Participants | 38 | 22 | 60 | |
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[Not Specified]
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Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 38 participants | 22 participants | 60 participants |
<65 years |
9 23.7%
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6 27.3%
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15 25.0%
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>=65 years |
29 76.3%
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16 72.7%
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45 75.0%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 38 participants | 22 participants | 60 participants | |
Female |
4 10.5%
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5 22.7%
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9 15.0%
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Male |
34 89.5%
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17 77.3%
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51 85.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 38 participants | 22 participants | 60 participants | |
Hispanic or Latino |
1 2.6%
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0 0.0%
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1 1.7%
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Not Hispanic or Latino |
37 97.4%
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22 100.0%
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59 98.3%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 38 participants | 22 participants | 60 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
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0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
2 5.3%
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0 0.0%
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2 3.3%
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White |
36 94.7%
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22 100.0%
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58 96.7%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Weight
Mean (Standard Deviation) Unit of measure: Kg |
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Number Analyzed | 38 participants | 22 participants | 60 participants | |
81.63 (16.203) | 73.83 (12.340) | 78.77 (15.271) | ||
Height
Mean (Standard Deviation) Unit of measure: Cm |
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Number Analyzed | 38 participants | 22 participants | 60 participants | |
174.51 (8.295) | 168.41 (7.102) | 172.28 (8.359) | ||
Body Mass Index
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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Number Analyzed | 38 participants | 22 participants | 60 participants | |
26.702 (4.3292) | 26.076 (4.4584) | 26.473 (4.3498) | ||
Body Surface Area
Mean (Standard Deviation) Unit of measure: M^2 |
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Number Analyzed | 38 participants | 22 participants | 60 participants | |
1.982 (0.2230) | 1.852 (0.1756) | 1.935 (0.2148) |
Name/Title: | Corporate Communications |
Organization: | Aduro Biotech, Inc. |
Phone: | 510-848-4400 |
EMail: | press@aduro.com |
Responsible Party: | Aduro Biotech, Inc. |
ClinicalTrials.gov Identifier: | NCT01675765 |
Other Study ID Numbers: |
ADU-CL-02 |
First Submitted: | August 23, 2012 |
First Posted: | August 30, 2012 |
Results First Submitted: | September 2, 2020 |
Results First Posted: | September 30, 2020 |
Last Update Posted: | September 30, 2020 |