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

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Aduro Biotech, Inc.

Study Type	Interventional
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

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Immunotherapy Plus Chemotherapy	Immunotherapy With Cyclophosphamide Plus Chemotherapy
Arm/Group Description	Weeks 1 and 3: CRS-207 (1 × 10^9 CF...	Weeks 1 and 3: cyclophosphamide (20...
Arm/Group Description	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

Baseline Characteristics

Arm/Group Title		Immunotherapy Plus Chemotherapy	Immunotherapy With Cyclophosphamide Plus Chemotherapy	Total
Arm/Group Description		Weeks 1 and 3: CRS-207 (1 × 10^9 CF...	Weeks 1 and 3: cyclophosphamide (20...	Total of all reporting groups
Arm/Group Description		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
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Customized Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	38 participants	22 participants	60 participants
<65 years		9 23.7%	6 27.3%	15 25.0%
>=65 years		29 76.3%	16 72.7%	45 75.0%
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	38 participants	22 participants	60 participants
	Female	4 10.5%	5 22.7%	9 15.0%
	Male	34 89.5%	17 77.3%	51 85.0%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	38 participants	22 participants	60 participants
	Hispanic or Latino	1 2.6%	0 0.0%	1 1.7%
	Not Hispanic or Latino	37 97.4%	22 100.0%	59 98.3%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	38 participants	22 participants	60 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	2 5.3%	0 0.0%	2 3.3%
	White	36 94.7%	22 100.0%	58 96.7%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Weight Mean (Standard Deviation) Unit of measure: Kg
	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
	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
	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
	Number Analyzed	38 participants	22 participants	60 participants
		1.982 (0.2230)	1.852 (0.1756)	1.935 (0.2148)

Outcome Measures

1.Primary Outcome


Title	Number of Subjects Reporting Adverse Events
Description	Count of subjects with incidences of adverse events.
Description	Count of subjects with incidences of adverse events.
Time Frame	From first study dose until 28 days after the final dose (an average of 44 weeks)

Outcome Measure Data

Analysis Population Description

Safety Analysis Set (all participants who received >= 1 dose of study treatment)


Arm/Group Title	Immunotherapy Plus Chemotherapy	Immunotherapy With Cyclophosphamide Plus Chemotherapy
Arm/Group Description:	Weeks 1 and 3: CRS-207 (1 × 10^9 CF...	Weeks 1 and 3: cyclophosphamide (20...
Arm/Group Description:	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
Overall Number of Participants Analyzed	38	22
Measure Type: Count of Participants Unit of Measure: Participants
	38 100.0%	22 100.0%

2.Primary Outcome


Title	Induction of Immune Response to Mesothelin by Enzyme-linked Immunosorbent Spot (ELISPOT) Assay
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Change over time assessed at multiple time points until disease progression or death (up to 12 months or longer)

Outcome Measure Data

Analysis Population Description

Immune response to mesothelin was not assessed.


Arm/Group Title	Immunotherapy Plus Chemotherapy	Immunotherapy With Cyclophosphamide Plus Chemotherapy
Arm/Group Description:	Weeks 1 and 3: CRS-207 (1 × 10^9 CF...	Weeks 1 and 3: cyclophosphamide (20...
Arm/Group Description:	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
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

3.Secondary Outcome


Title	Objective Tumor Response
Description	Objective tumor response was measured using modified Response Evaluati...
Description	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 Frame	Baseline to measured disease progression or death (up to 12 months or longer)

Outcome Measure Data

Analysis Population Description

Safety analysis set: all enrolled subjects who received at least one dose of study treatment and had measurable disease.


Arm/Group Title	Immunotherapy Plus Chemotherapy	Immunotherapy With Cyclophosphamide Plus Chemotherapy
Arm/Group Description:	Weeks 1 and 3: CRS-207 (1 × 10^9 CF...	Weeks 1 and 3: cyclophosphamide (20...
Arm/Group Description:	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
Overall Number of Participants Analyzed	36	21
Measure Type: Count of Participants Unit of Measure: Participants
Complete Response	1 2.8%	0 0.0%
Partial Response	19 52.8%	11 52.4%
Stable Disease	14 38.9%	8 38.1%
Progressive Disease	1 2.8%	2 9.5%
Not Assessable	1 2.8%	0 0.0%

4.Secondary Outcome


Title	Time to Progression
Description	[Not Specified]
Description	[Not Specified]
Time Frame	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

Outcome Measure Data

Analysis Population Description

Time to progression was not assessed.


Arm/Group Title	Immunotherapy Plus Chemotherapy	Immunotherapy With Cyclophosphamide Plus Chemotherapy
Arm/Group Description:	Weeks 1 and 3: CRS-207 (1 × 10^9 CF...	Weeks 1 and 3: cyclophosphamide (20...
Arm/Group Description:	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
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

5.Secondary Outcome


Title	Serum Mesothelin as Correlate of Therapeutic Response
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Change over time assessed at multiple time points until disease progression or death (up to 12 months or longer)

Outcome Measure Data

Analysis Population Description

Predictive value of serum mesothelin was not assessed.


Arm/Group Title	Immunotherapy Plus Chemotherapy	Immunotherapy With Cyclophosphamide Plus Chemotherapy
Arm/Group Description:	Weeks 1 and 3: CRS-207 (1 × 10^9 CF...	Weeks 1 and 3: cyclophosphamide (20...
Arm/Group Description:	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
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Immunotherapy Plus Chemotherapy	Immunotherapy With Cyclophosphamide Plus Chemotherapy
Arm/Group Description	Weeks 1 and 3: CRS-207 (1 × 10^9 CF...	Weeks 1 and 3: cyclophosphamide (20...
Arm/Group Description	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
All-Cause Mortality
	Immunotherapy Plus Chemotherapy	Immunotherapy With Cyclophosphamide Plus Chemotherapy
	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/38 (7.89%)	0/22 (0.00%)
Serious Adverse Events Serious Adverse Events
	Immunotherapy Plus Chemotherapy	Immunotherapy With Cyclophosphamide Plus Chemotherapy
	Affected / at Risk (%)	Affected / at Risk (%)
Total	15/38 (39.47%)	11/22 (50.00%)
Blood and lymphatic system disorders
Anaemia ^† 1	1/38 (2.63%)	1/22 (4.55%)
Cardiac disorders
Atrial fibrillation ^† 1	1/38 (2.63%)	0/22 (0.00%)
Gastrointestinal disorders
Constipation ^† 1	2/38 (5.26%)	1/22 (4.55%)
Nausea ^† 1	2/38 (5.26%)	0/22 (0.00%)
Vomiting ^† 1	2/38 (5.26%)	0/22 (0.00%)
Abdominal pain ^† 1	0/38 (0.00%)	1/22 (4.55%)
Diarrhoea ^† 1	1/38 (2.63%)	0/22 (0.00%)
Diverticular perforation ^† 1	0/38 (0.00%)	1/22 (4.55%)
Gastric ulcer haemorrhage ^† 1	1/38 (2.63%)	0/22 (0.00%)
Large intestine perforation ^† 1	0/38 (0.00%)	1/22 (4.55%)
Pancreatitis acute ^† 1	1/38 (2.63%)	0/22 (0.00%)
Small intestinal obstruction ^† 1	1/38 (2.63%)	0/22 (0.00%)
General disorders
Chills ^† 1	1/38 (2.63%)	1/22 (4.55%)
Pyrexia ^† 1	1/38 (2.63%)	1/22 (4.55%)
Disease progression ^† 1	1/38 (2.63%)	0/22 (0.00%)
Influenza like illness ^† 1	0/38 (0.00%)	1/22 (4.55%)
Infections and infestations
Pneumonia ^† 1	1/38 (2.63%)	2/22 (9.09%)
Sepsis ^† 1	0/38 (0.00%)	1/22 (4.55%)
Metabolism and nutrition disorders
Hypoglycaemia ^† 1	1/38 (2.63%)	0/22 (0.00%)
Musculoskeletal and connective tissue disorders
Polyarthritis ^† 1	1/38 (2.63%)	0/22 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord neoplasm ^† 1	1/38 (2.63%)	0/22 (0.00%)
Nervous system disorders
Headache ^† 1	1/38 (2.63%)	0/22 (0.00%)
Syncope ^† 1	0/38 (0.00%)	1/22 (4.55%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^† 1	3/38 (7.89%)	0/22 (0.00%)
Haemothorax ^† 1	1/38 (2.63%)	0/22 (0.00%)
Hypoxia ^† 1	0/38 (0.00%)	1/22 (4.55%)
Pleuritic pain ^† 1	0/38 (0.00%)	1/22 (4.55%)
Pulmonary embolism ^† 1	1/38 (2.63%)	0/22 (0.00%)
1 Term from vocabulary, MedDRA (15.0) † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Immunotherapy Plus Chemotherapy	Immunotherapy With Cyclophosphamide Plus Chemotherapy
	Affected / at Risk (%)	Affected / at Risk (%)
Total	38/38 (100.00%)	22/22 (100.00%)
Blood and lymphatic system disorders
Anaemia ^† 1	15/38 (39.47%)	8/22 (36.36%)
Neutropenia ^† 1	3/38 (7.89%)	3/22 (13.64%)
Leukopenia ^† 1	3/38 (7.89%)	0/22 (0.00%)
Leukocytosis ^† 1	2/38 (5.26%)	0/22 (0.00%)
Cardiac disorders
Sinus tachycardia ^† 1	4/38 (10.53%)	1/22 (4.55%)
Atrial fibrillation ^† 1	1/38 (2.63%)	2/22 (9.09%)
Tachycardia ^† 1	2/38 (5.26%)	1/22 (4.55%)
Ear and labyrinth disorders
Tinnitus ^† 1	5/38 (13.16%)	1/22 (4.55%)
Vertigo ^† 1	2/38 (5.26%)	0/22 (0.00%)
Eye disorders
Lacrimation increased ^† 1	6/38 (15.79%)	1/22 (4.55%)
Gastrointestinal disorders
Nausea ^† 1	31/38 (81.58%)	12/22 (54.55%)
Vomiting ^† 1	25/38 (65.79%)	5/22 (22.73%)
Constipation ^† 1	15/38 (39.47%)	7/22 (31.82%)
Diarrhoea ^† 1	8/38 (21.05%)	2/22 (9.09%)
Abdominal pain ^† 1	4/38 (10.53%)	5/22 (22.73%)
Dry mouth ^† 1	4/38 (10.53%)	0/22 (0.00%)
Ascites ^† 1	2/38 (5.26%)	1/22 (4.55%)
Gastrooesophageal reflux disease ^† 1	2/38 (5.26%)	1/22 (4.55%)
Abdominal discomfort ^† 1	2/38 (5.26%)	0/22 (0.00%)
Dyspepsia ^† 1	2/38 (5.26%)	0/22 (0.00%)
Flatulence ^† 1	0/38 (0.00%)	2/22 (9.09%)
General disorders
Chills ^† 1	37/38 (97.37%)	22/22 (100.00%)
Pyrexia ^† 1	37/38 (97.37%)	21/22 (95.45%)
Fatigue ^† 1	23/38 (60.53%)	12/22 (54.55%)
Oedema peripheral ^† 1	7/38 (18.42%)	3/22 (13.64%)
Non-cardiac chest pain ^† 1	5/38 (13.16%)	0/22 (0.00%)
Malaise ^† 1	3/38 (7.89%)	0/22 (0.00%)
Chest pain ^† 1	2/38 (5.26%)	0/22 (0.00%)
Oedema ^† 1	2/38 (5.26%)	0/22 (0.00%)
Mucosal inflammation ^† 1	2/38 (5.26%)	0/22 (0.00%)
Infections and infestations
Upper respiratory tract infection ^† 1	3/38 (7.89%)	1/22 (4.55%)
Pneumonia ^† 1	1/38 (2.63%)	2/22 (9.09%)
Sinusitis ^† 1	2/38 (5.26%)	1/22 (4.55%)
Urinary tract infection ^† 1	3/38 (7.89%)	0/22 (0.00%)
Investigations
Blood creatinine increased ^† 1	6/38 (15.79%)	7/22 (31.82%)
White blood cell count decreased ^† 1	7/38 (18.42%)	3/22 (13.64%)
Alanine aminotransferase increased ^† 1	7/38 (18.42%)	1/22 (4.55%)
Lymphocyte count decreased ^† 1	5/38 (13.16%)	3/22 (13.64%)
Neutrophil count decreased ^† 1	7/38 (18.42%)	1/22 (4.55%)
Aspartate aminotransferase increased ^† 1	6/38 (15.79%)	1/22 (4.55%)
Platelet count decreased ^† 1	5/38 (13.16%)	2/22 (9.09%)
Weight decreased ^† 1	4/38 (10.53%)	2/22 (9.09%)
Blood alkaline phosphatase increased ^† 1	1/38 (2.63%)	3/22 (13.64%)
Haemoglobin decreased ^† 1	2/38 (5.26%)	2/22 (9.09%)
Blood urea increased ^† 1	3/38 (7.89%)	0/22 (0.00%)
Weight increased ^† 1	3/38 (7.89%)	0/22 (0.00%)
Blood albumin decreased ^† 1	2/38 (5.26%)	0/22 (0.00%)
Haematocrit decreased ^† 1	0/38 (0.00%)	2/22 (9.09%)
Metabolism and nutrition disorders
Decreased appetite ^† 1	19/38 (50.00%)	4/22 (18.18%)
Hyponatraemia ^† 1	8/38 (21.05%)	3/22 (13.64%)
Hypoalbuminaemia ^† 1	7/38 (18.42%)	3/22 (13.64%)
Hypomagnesaemia ^† 1	6/38 (15.79%)	4/22 (18.18%)
Hyperglycaemia ^† 1	7/38 (18.42%)	2/22 (9.09%)
Hyperkalaemia ^† 1	5/38 (13.16%)	4/22 (18.18%)
Dehydration ^† 1	5/38 (13.16%)	2/22 (9.09%)
Hypophosphataemia ^† 1	5/38 (13.16%)	1/22 (4.55%)
Hypocalcaemia ^† 1	4/38 (10.53%)	1/22 (4.55%)
Musculoskeletal and connective tissue disorders
Back pain ^† 1	7/38 (18.42%)	3/22 (13.64%)
Musculoskeletal chest pain ^† 1	2/38 (5.26%)	2/22 (9.09%)
Musculoskeletal pain ^† 1	3/38 (7.89%)	1/22 (4.55%)
Arthralgia ^† 1	3/38 (7.89%)	0/22 (0.00%)
Muscular weakness ^† 1	2/38 (5.26%)	0/22 (0.00%)
Myalgia ^† 1	2/38 (5.26%)	0/22 (0.00%)
Pain in extremity ^† 1	0/38 (0.00%)	2/22 (9.09%)
Nervous system disorders
Headache ^† 1	11/38 (28.95%)	6/22 (27.27%)
Dizziness ^† 1	8/38 (21.05%)	1/22 (4.55%)
Neuropathy peripheral ^† 1	6/38 (15.79%)	2/22 (9.09%)
Dysgeusia ^† 1	5/38 (13.16%)	0/22 (0.00%)
Syncope ^† 1	2/38 (5.26%)	2/22 (9.09%)
Tremor ^† 1	2/38 (5.26%)	0/22 (0.00%)
Psychiatric disorders
Insomnia ^† 1	4/38 (10.53%)	5/22 (22.73%)
Anxiety ^† 1	1/38 (2.63%)	2/22 (9.09%)
Depression ^† 1	2/38 (5.26%)	1/22 (4.55%)
Renal and urinary disorders
Renal impairment ^† 1	0/38 (0.00%)	2/22 (9.09%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^† 1	10/38 (26.32%)	5/22 (22.73%)
Cough ^† 1	8/38 (21.05%)	0/22 (0.00%)
Rhinorrhoea ^† 1	6/38 (15.79%)	2/22 (9.09%)
Hiccups ^† 1	6/38 (15.79%)	1/22 (4.55%)
Hypoxia ^† 1	1/38 (2.63%)	4/22 (18.18%)
Dyspnoea exertional ^† 1	3/38 (7.89%)	1/22 (4.55%)
Pleural effusion ^† 1	4/38 (10.53%)	0/22 (0.00%)
Dysphonia ^† 1	3/38 (7.89%)	0/22 (0.00%)
Pulmonary embolism ^† 1	3/38 (7.89%)	0/22 (0.00%)
Nasal congestion ^† 1	0/38 (0.00%)	2/22 (9.09%)
Tachypnoea ^† 1	2/38 (5.26%)	0/22 (0.00%)
Throat irritation ^† 1	2/38 (5.26%)	0/22 (0.00%)
Skin and subcutaneous tissue disorders
Rash ^† 1	6/38 (15.79%)	1/22 (4.55%)
Night sweats ^† 1	5/38 (13.16%)	1/22 (4.55%)
Rash maculo-papular ^† 1	4/38 (10.53%)	1/22 (4.55%)
Hyperhidrosis ^† 1	4/38 (10.53%)	0/22 (0.00%)
Pruritus ^† 1	4/38 (10.53%)	0/22 (0.00%)
Urticaria ^† 1	3/38 (7.89%)	0/22 (0.00%)
Vascular disorders
Hypotension ^† 1	9/38 (23.68%)	4/22 (18.18%)
Hypertension ^† 1	6/38 (15.79%)	2/22 (9.09%)
Flushing ^† 1	3/38 (7.89%)	1/22 (4.55%)
Deep vein thrombosis ^† 1	2/38 (5.26%)	0/22 (0.00%)
Jugular vein thrombosis ^† 1	2/38 (5.26%)	0/22 (0.00%)
1 Term from vocabulary, MedDRA (15.0) † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Disclosure restriction - study results first published in a joint multi-center paper unless (a) no multi-center publication, or (b) ≥18 months has passed since completion of the study. Thereafter, Investigator may publish provided that Investigator: (i) provides a copy of the publication to Aduro ≥ 30 days in advance of submission for publication; (ii) deletes Aduro Confidential Information (other than the Study results) and (iii) submission may be delayed up to 90 days to permit IP filings."

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Corporate Communications
Organization:	Aduro Biotech, Inc.
Phone:	510-848-4400
EMail:	press@aduro.com

Publications:

Le DT, Dubenksy TW Jr, Brockstedt DG. Clinical development of Listeria monocytogenes-based immunotherapies. Semin Oncol. 2012 Jun;39(3):311-22. doi: 10.1053/j.seminoncol.2012.02.008.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hassan R, Alley E, Kindler H, Antonia S, Jahan T, Honarmand S, Nair N, Whiting CC, Enstrom A, Lemmens E, Tsujikawa T, Kumar S, Choe G, Thomas A, McDougall K, Murphy AL, Jaffee E, Coussens LM, Brockstedt DG. Clinical Response of Live-Attenuated, Listeria monocytogenes Expressing Mesothelin (CRS-207) with Chemotherapy in Patients with Malignant Pleural Mesothelioma. Clin Cancer Res. 2019 Oct 1;25(19):5787-5798. doi: 10.1158/1078-0432.CCR-19-0070. Epub 2019 Jul 1.

Layout table for additonal information

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

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