Trial Outcomes & Findings for CV301 Combined With PD-1/L1 Blockade in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer (NCT NCT03628716)

Last Updated: 2022-04-27

Results Overview

ORR is the proportion of subjects in the analysis population with a Complete Response (CR) or Partial Response (PR) based on best overall RECIST v1.1 evaluations as performed by the investigator. According to RECIST v1.1, the sum of the longest diameters of non-nodal target lesions and short axis of nodal target lesions are used to evaluate tumor response. Maximum of 2 target lesions per organ and 5 target lesions are used for the measurement. CR means disappearance of all known disease, confirmed at 4 week, lymph nodes must be \< 10 mm short axis. PR means \>=30% decrease from baseline measurement, confirmed at 4 week.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

up to 24 months

Results posted on

2022-04-27

Participant Flow

Participant milestones

Participant milestones
Measure	CV301 + Atezolizumab (Cohort 1) Cohort 1 - Combination of CV301 with atezolizumab in the first-line treatment of urothelia cancer not eligible for cisplatin-containing chemotherapy	CV301 + Atezolizumab (Cohort 2) Cohort 2 - Combination of CV301 with atezolizumab in the second-line treatment of urothelia cancer previously treated with standard first-line cisplatin-based chemotherapy
Overall Study STARTED	19	24
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	19	23

Reasons for withdrawal

Reasons for withdrawal
Measure	CV301 + Atezolizumab (Cohort 1) Cohort 1 - Combination of CV301 with atezolizumab in the first-line treatment of urothelia cancer not eligible for cisplatin-containing chemotherapy	CV301 + Atezolizumab (Cohort 2) Cohort 2 - Combination of CV301 with atezolizumab in the second-line treatment of urothelia cancer previously treated with standard first-line cisplatin-based chemotherapy
Overall Study Adverse Event	1	1
Overall Study Death	1	0
Overall Study Lack of Efficacy	15	20
Overall Study Withdrawal by Subject	1	2
Overall Study Study Terminated by Sponsor	1	0

Baseline Characteristics

CV301 Combined With PD-1/L1 Blockade in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CV301 + Atezolizumab (Cohort 1) n=19 Participants Cohort 1 - Combination of CV301 with atezolizumab in the first-line treatment of urothelia cancer not eligible for cisplatin-containing chemotherapy	CV301 + Atezolizumab (Cohort 2) n=24 Participants Cohort 2 - Combination of CV301 with atezolizumab in the second-line treatment of urothelia cancer previously treated with standard first-line cisplatin-based chemotherapy	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Age, Continuous	79.0 years STANDARD_DEVIATION 5.97 • n=5 Participants	66.8 years STANDARD_DEVIATION 10.99 • n=7 Participants	72.2 years STANDARD_DEVIATION 10.91 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	23 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	23 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	19 Participants n=5 Participants	24 Participants n=7 Participants	43 Participants n=5 Participants
ECOG Status Grade 0	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
ECOG Status Grade 1	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
ECOG Status Grade >=2	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Primary Tumor Site Renal Pelvis	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Primary Tumor Site Ureter	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Primary Tumor Site Urethra	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Primary Tumor Site Urinary Bladder	13 Participants n=5 Participants	21 Participants n=7 Participants	34 Participants n=5 Participants
Stage at Diagnosis Stage I	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Stage at Diagnosis Stage II	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Stage at Diagnosis Stage III	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Stage at Diagnosis Stage IV	7 Participants n=5 Participants	16 Participants n=7 Participants	23 Participants n=5 Participants
T Category TX	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
T Category T0	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
T Category Ta	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
T Category Tis	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
T Category T1	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
T Category T2a	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
T Category T2b	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
T Category T3a	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
T Category T3b	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
T Category T4a	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
T Category T4b	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
N Category NX	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
N Category N0	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
N Category N1	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
N Category N2	1 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants
N Category N3	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
M Category M0	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
M Category M1	8 Participants n=5 Participants	14 Participants n=7 Participants	22 Participants n=5 Participants
M Category Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Baseline PD-L1 Expression Tumor Proportion Score <1%	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Baseline PD-L1 Expression Tumor Proportion Score >=1%-1<10%	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Baseline PD-L1 Expression Tumor Proportion Score >=10%	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline PD-L1 Expression Tumor Proportion Score Not Applicable	16 Participants n=5 Participants	20 Participants n=7 Participants	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 24 months

Population: Full Analysis Set subjects with objective response

Outcome measures

Outcome measures
Measure	CV301 + Atezolizumab (Cohort 1) n=19 Participants Cohort 1 - Combination of CV301 with atezolizumab in the first-line treatment of urothelia cancer not eligible for cisplatin-containing chemotherapy	CV301 + Atezolizumab (Cohort 2) n=24 Participants Cohort 2 - Combination of CV301 with atezolizumab in the second-line treatment of urothelia cancer previously treated with standard first-line cisplatin-based chemotherapy
Objective Response Rate (ORR)	1 Participants	2 Participants

SECONDARY outcome

Timeframe: The time from day of first treatment to the start of disease progression or death, whichever occurs first, or the last assessment date if there is a lack of progression, up to 24 months for each subject or discontinuation of the study by sponsor.

Population: Full Analysis Set subjects with objective response

The time interval from first treatment to objective tumor progression or death of any cause. Subjects without death or progression are censored at the date when the last assessment determined a lack of progression. The time interval from first vaccination to death of any cause, up to 4 years for each subject or discontinuation of the study by sponsor.

Outcome measures

Outcome measures
Measure	CV301 + Atezolizumab (Cohort 1) n=19 Participants Cohort 1 - Combination of CV301 with atezolizumab in the first-line treatment of urothelia cancer not eligible for cisplatin-containing chemotherapy	CV301 + Atezolizumab (Cohort 2) n=24 Participants Cohort 2 - Combination of CV301 with atezolizumab in the second-line treatment of urothelia cancer previously treated with standard first-line cisplatin-based chemotherapy
Progression Free Survival (PFS)	2 Months Interval 1.68 to 2.1	1.95 Months Interval 1.87 to 2.07

SECONDARY outcome

Timeframe: The time interval from first vaccination to death of any cause, up to 24 months for each subject or discontinuation of the study by sponsor.

Population: Full Analysis Set: consists of all subjects taking any amount of trial vaccine

Time interval from first treatment to death of any cause. Subjects are censored at their date of last contact if they did not meet the survival endpoint by the outcome measure time frame.

Outcome measures

Outcome measures
Measure	CV301 + Atezolizumab (Cohort 1) n=19 Participants Cohort 1 - Combination of CV301 with atezolizumab in the first-line treatment of urothelia cancer not eligible for cisplatin-containing chemotherapy	CV301 + Atezolizumab (Cohort 2) n=24 Participants Cohort 2 - Combination of CV301 with atezolizumab in the second-line treatment of urothelia cancer previously treated with standard first-line cisplatin-based chemotherapy
Overall Survival (OS)	13.8 Months Interval 2.37 to It is NA because it is not evaluable. There are insufficient subjects with events.	8.13 Months Interval 4.3 to It is NA because it is not evaluable. There are insufficient subjects with events.

SECONDARY outcome

Timeframe: up to 24 months

Population: Full Analysis Set subjects with objective response

The time from objective response (CR or PR, whichever comes first) to investigator assessed progression using RECIST v1.1 or death

Outcome measures

Outcome measures
Measure	CV301 + Atezolizumab (Cohort 1) n=1 Participants Cohort 1 - Combination of CV301 with atezolizumab in the first-line treatment of urothelia cancer not eligible for cisplatin-containing chemotherapy	CV301 + Atezolizumab (Cohort 2) n=2 Participants Cohort 2 - Combination of CV301 with atezolizumab in the second-line treatment of urothelia cancer previously treated with standard first-line cisplatin-based chemotherapy
Duration of Response	NA Months It is NA because it is not evaluable. There are insufficient subject with events for estimation.	NA Months It is NA because it is not evaluable. There are insufficient subject with events for estimation.

SECONDARY outcome

Timeframe: up to 24 months

Population: The Full Analysis Set consists of all subjects taking any amount of trial vaccine

An Overall Summary of Subjects with any Treatment-Emergent Adverse Events (TEAEs) and TEAEs Categories. TEAEs Categories include Related Adverse Events, \>=Grade 3 Adverse Events, Related \>= Grade 3 Adverse Events, Serious Adverse Events, Related Serious Adverse Events, Adverse Events of Special Interest and Related Adverse Events of Special Interest. TEAEs are considered as related when the investigator-assessed relationship of the corresponding trial treatment is "possible", "probable", "definite" or missing. Per CTCAE v5, Grade 1=Mild; asymptomatic or mild symptoms. Grade 2=Moderate; minimal, local or noninvasive intervention indicated. Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4=Life-threatening consequences; urgent intervention indicated. Grade 5=Death related to AE. Immune Mediated Adverse Events (IMAE) and Cardiac events are considered AESIs.

Outcome measures

Outcome measures
Measure	CV301 + Atezolizumab (Cohort 1) n=19 Participants Cohort 1 - Combination of CV301 with atezolizumab in the first-line treatment of urothelia cancer not eligible for cisplatin-containing chemotherapy	CV301 + Atezolizumab (Cohort 2) n=24 Participants Cohort 2 - Combination of CV301 with atezolizumab in the second-line treatment of urothelia cancer previously treated with standard first-line cisplatin-based chemotherapy
Treatment-Emergent Adverse Events Adverse Events of Special Interest	1 Participants	1 Participants
Treatment-Emergent Adverse Events Treatment Emergent Adverse Events	19 Participants	24 Participants
Treatment-Emergent Adverse Events Related Adverse Events	16 Participants	21 Participants
Treatment-Emergent Adverse Events >= Grade 3 Adverse Events	10 Participants	12 Participants
Treatment-Emergent Adverse Events Related >= Grade 3 Adverse Events	5 Participants	4 Participants
Treatment-Emergent Adverse Events Serious Adverse Events	7 Participants	5 Participants
Treatment-Emergent Adverse Events Related Serious Adverse Events	0 Participants	1 Participants
Treatment-Emergent Adverse Events Related Adverse Events of Special Interest	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Overall Study up to 24 months

Population: The Full Analysis Set consists of all subjects taking any amount of trial vaccine

Toxicity grades are based on CTCAE v5 scales for hematology and chemistry laboratory parameters. Grade 0=Normal, Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 5=Life-threatening, and Grade 5=Death. Toxicity grade shift is defined to evaluate categorical changes from baseline results to post-treatment results with respect to dichotomized CTCAE v5 grading value (\<= Grade 2, \>= Grade 3).

Outcome measures

Outcome measures
Measure	CV301 + Atezolizumab (Cohort 1) n=19 Participants Cohort 1 - Combination of CV301 with atezolizumab in the first-line treatment of urothelia cancer not eligible for cisplatin-containing chemotherapy	CV301 + Atezolizumab (Cohort 2) n=24 Participants Cohort 2 - Combination of CV301 with atezolizumab in the second-line treatment of urothelia cancer previously treated with standard first-line cisplatin-based chemotherapy
Toxicity Grade Shift From Baseline in Laboratory Results Alkaline Phosphatase <= Grade 2	18 Participants	24 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Alkaline Phosphatase >= Grade 3	0 Participants	0 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Amylase <= Grade 2	17 Participants	24 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Bilirubin <= Grade 2	17 Participants	24 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Bilirubin >= Grade 3	1 Participants	0 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Sodium >= Grade 3	0 Participants	2 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Thyrotropin >= Grade 3	0 Participants	0 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Amylase >= Grade 3	1 Participants	0 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Aspartate Aminotransferase <= Grade 2	18 Participants	24 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Aspartate Aminotransferase >= Grade 3	0 Participants	0 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Bicarbonate <= Grade 2	18 Participants	24 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Bicarbonate >= Grade 3	0 Participants	0 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Eosinophils <= Grade 2	18 Participants	24 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Eosinophils >= Grade 3	0 Participants	0 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Hemoglobin <= Grade 2	18 Participants	24 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Hemoglobin >= Grade 3	0 Participants	0 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Leukocytes <= Grade 2	18 Participants	24 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Leukocytes >= Grade 3	0 Participants	0 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Lymphocytes <= Grade 2	16 Participants	22 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Lymphocytes >= Grade 3	2 Participants	2 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Neutrophils <= Grade 2	18 Participants	24 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Neutrophils >= Grade 3	0 Participants	0 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Platelets <= Grade 2	18 Participants	24 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Platelets >= Grade 3	0 Participants	0 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Alanine Aminotransferase <= Grade 2	18 Participants	24 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Alanine Aminotransferase >= Grade 3	0 Participants	0 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Albumin <= Grade 2	18 Participants	24 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Albumin >= Grade 3	0 Participants	0 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Calcium <= Grade 2	18 Participants	24 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Calcium >= Grade 3	0 Participants	0 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Creatinine <= Grade 2	16 Participants	24 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Creatinine >= Grade 3	2 Participants	0 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Glucose <= Grade 2	18 Participants	24 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Glucose >= Grade 3	0 Participants	0 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Lactate Dehydrogenase <= Grade 2	18 Participants	24 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Lactate Dehydrogenase >= Grade 3	0 Participants	0 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Lipase <= Grade 2	15 Participants	23 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Lipase >= Grade 3	3 Participants	1 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Potassium <= Grade 2	18 Participants	24 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Potassium >= Grade 3	0 Participants	0 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Sodium <= Grade 2	18 Participants	22 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Thyrotropin <= Grade 2	13 Participants	18 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Urate <= Grade 2	12 Participants	21 Participants
Toxicity Grade Shift From Baseline in Laboratory Results Urate >= Grade 3	6 Participants	3 Participants

SECONDARY outcome

Timeframe: Overall study up to 24 months

Population: The Full Analysis Set consists of all subjects taking any amount of trial vaccine

Vital signs results assessed throughout the study.

Outcome measures

Outcome measures
Measure	CV301 + Atezolizumab (Cohort 1) n=19 Participants Cohort 1 - Combination of CV301 with atezolizumab in the first-line treatment of urothelia cancer not eligible for cisplatin-containing chemotherapy	CV301 + Atezolizumab (Cohort 2) n=24 Participants Cohort 2 - Combination of CV301 with atezolizumab in the second-line treatment of urothelia cancer previously treated with standard first-line cisplatin-based chemotherapy
Vital Signs Results - Pulse Rate Baseline	76.4 beats per minute Standard Deviation 13.41	75.3 beats per minute Standard Deviation 15.31
Vital Signs Results - Pulse Rate Week 4	72.7 beats per minute Standard Deviation 11.49	79.4 beats per minute Standard Deviation 17.61
Vital Signs Results - Pulse Rate Week 7	70.2 beats per minute Standard Deviation 12.06	76.5 beats per minute Standard Deviation 15.56
Vital Signs Results - Pulse Rate Week 10	66.8 beats per minute Standard Deviation 8.84	79.5 beats per minute Standard Deviation 17.06
Vital Signs Results - Pulse Rate Week 13	73.6 beats per minute Standard Deviation 11.45	75.0 beats per minute Standard Deviation 18.46
Vital Signs Results - Pulse Rate Week 16	66.5 beats per minute Standard Deviation 5.58	76.7 beats per minute Standard Deviation 15.74
Vital Signs Results - Pulse Rate Week 19	66.4 beats per minute Standard Deviation 11.01	76.2 beats per minute Standard Deviation 17.49
Vital Signs Results - Pulse Rate Week 22	72.2 beats per minute Standard Deviation 16.95	71.7 beats per minute Standard Deviation 18.04
Vital Signs Results - Pulse Rate Week 25	68.7 beats per minute Standard Deviation 17.56	83.0 beats per minute Standard Deviation 13.73
Vital Signs Results - Pulse Rate Week 28	57.3 beats per minute Standard Deviation 5.51	83.4 beats per minute Standard Deviation 23.95
Vital Signs Results - Pulse Rate Week 31	64.0 beats per minute Standard Deviation 11.14	86.0 beats per minute Standard Deviation 14.73
Vital Signs Results - Pulse Rate Week 34	67.3 beats per minute Standard Deviation 13.58	74.7 beats per minute Standard Deviation 8.08
Vital Signs Results - Pulse Rate Week 37	76.5 beats per minute Standard Deviation 30.41	80.0 beats per minute Standard Deviation 10.15
Vital Signs Results - Pulse Rate Week 40	67.0 beats per minute Standard Deviation 14.11	84.7 beats per minute Standard Deviation 13.32
Vital Signs Results - Pulse Rate Week 43	68.0 beats per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 subjects were analyzed.	85.3 beats per minute Standard Deviation 17.21
Vital Signs Results - Pulse Rate Week 46	69.0 beats per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	91.7 beats per minute Standard Deviation 11.37
Vital Signs Results - Pulse Rate Week 49	93.0 beats per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	80.0 beats per minute Standard Deviation 6.93
Vital Signs Results - Pulse Rate Week 52	75.0 beats per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	94.7 beats per minute Standard Deviation 17.5
Vital Signs Results - Pulse Rate Week 55	79.0 beats per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	74.0 beats per minute Standard Deviation 7.07
Vital Signs Results - Pulse Rate Week 58	—	75.5 beats per minute Standard Deviation 0.71
Vital Signs Results - Pulse Rate Week 61	68.0 beats per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	77.5 beats per minute Standard Deviation 10.61
Vital Signs Results - Pulse Rate Week 64	81.0 beats per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	81.0 beats per minute Standard Deviation 1.41
Vital Signs Results - Pulse Rate Week 67	—	81.0 beats per minute Standard Deviation 2.83
Vital Signs Results - Pulse Rate Week 70	80.0 beats per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	73.0 beats per minute Standard Deviation 5.66
Vital Signs Results - Pulse Rate Week 73	—	72.0 beats per minute Standard Deviation 9.90
Vital Signs Results - Pulse Rate Week 76	—	85.0 beats per minute Standard Deviation 5.66
Vital Signs Results - Pulse Rate Week 79	77.0 beats per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	76.0 beats per minute Standard Deviation 12.73
Vital Signs Results - Pulse Rate Week 82	—	73.0 beats per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Pulse Rate Week 85	80.0 beats per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	66.0 beats per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Pulse Rate Week 88	—	77.0 beats per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Pulse Rate Week 91	58.0 beats per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	69.0 beats per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Pulse Rate Week 94	83.0 beats per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	84.0 beats per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Pulse Rate Week 97	63.0 beats per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	81.0 beats per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Pulse Rate Week 100	64.0 beats per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	93.0 beats per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.

SECONDARY outcome

Timeframe: Overall study up to 24 months

Population: The Full Analysis Set consists of all subjects taking any amount of trial vaccine

Vital signs results assessed throughout the study.

Outcome measures

Outcome measures
Measure	CV301 + Atezolizumab (Cohort 1) n=19 Participants Cohort 1 - Combination of CV301 with atezolizumab in the first-line treatment of urothelia cancer not eligible for cisplatin-containing chemotherapy	CV301 + Atezolizumab (Cohort 2) n=24 Participants Cohort 2 - Combination of CV301 with atezolizumab in the second-line treatment of urothelia cancer previously treated with standard first-line cisplatin-based chemotherapy
Vital Signs Results - System Blood Pressure Week 7	135.1 mmHg Standard Deviation 20.35	125.9 mmHg Standard Deviation 11.29
Vital Signs Results - System Blood Pressure Week 10	130.0 mmHg Standard Deviation 18.13	126.5 mmHg Standard Deviation 11.75
Vital Signs Results - System Blood Pressure Week 13	129.9 mmHg Standard Deviation 12.19	129.7 mmHg Standard Deviation 7.5
Vital Signs Results - System Blood Pressure Week 61	150.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	132.0 mmHg Standard Deviation 9.9
Vital Signs Results - System Blood Pressure Baseline	127.0 mmHg Standard Deviation 18.72	129.9 mmHg Standard Deviation 16.15
Vital Signs Results - System Blood Pressure Week 4	121.3 mmHg Standard Deviation 16.43	123.2 mmHg Standard Deviation 13.29
Vital Signs Results - System Blood Pressure Week 16	133.5 mmHg Standard Deviation 17.88	127.4 mmHg Standard Deviation 10.16
Vital Signs Results - System Blood Pressure Week 19	141.2 mmHg Standard Deviation 17.91	113.7 mmHg Standard Deviation 12.08
Vital Signs Results - System Blood Pressure Week 22	139.2 mmHg Standard Deviation 36.08	121.0 mmHg Standard Deviation 11.49
Vital Signs Results - System Blood Pressure Week 25	146.0 mmHg Standard Deviation 27.06	129.4 mmHg Standard Deviation 12.54
Vital Signs Results - System Blood Pressure Week 28	139.3 mmHg Standard Deviation 35.8	123.8 mmHg Standard Deviation 11.69
Vital Signs Results - System Blood Pressure Week 31	134.7 mmHg Standard Deviation 6.66	118.7 mmHg Standard Deviation 3.79
Vital Signs Results - System Blood Pressure Week 34	130.3 mmHg Standard Deviation 8.74	124.3 mmHg Standard Deviation 4.51
Vital Signs Results - System Blood Pressure Week 37	140.0 mmHg Standard Deviation 1.41	138.0 mmHg Standard Deviation 19.92
Vital Signs Results - System Blood Pressure Week 40	140.0 mmHg Standard Deviation 20.42	111.0 mmHg Standard Deviation 15.87
Vital Signs Results - System Blood Pressure Week 43	141.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	129.3 mmHg Standard Deviation 11.72
Vital Signs Results - System Blood Pressure Week 46	177.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	132.7 mmHg Standard Deviation 3.79
Vital Signs Results - System Blood Pressure Week 49	150.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	127.7 mmHg Standard Deviation 15.04
Vital Signs Results - System Blood Pressure Week 52	154.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	120.3 mmHg Standard Deviation 17.79
Vital Signs Results - System Blood Pressure Week 55	149.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	139.0 mmHg Standard Deviation 4.24
Vital Signs Results - System Blood Pressure Week 58	—	134.0 mmHg Standard Deviation 2.83
Vital Signs Results - System Blood Pressure Week 64	155.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	129.0 mmHg Standard Deviation 1.41
Vital Signs Results - System Blood Pressure Week 67	—	143.0 mmHg Standard Deviation 8.49
Vital Signs Results - System Blood Pressure Week 70	148.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	138.5 mmHg Standard Deviation 10.61
Vital Signs Results - System Blood Pressure Week 73	—	140.0 mmHg Standard Deviation 11.31
Vital Signs Results - System Blood Pressure Week 76	—	119.0 mmHg Standard Deviation 26.87
Vital Signs Results - System Blood Pressure Week 79	142.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	125.0 mmHg Standard Deviation 1.41
Vital Signs Results - System Blood Pressure Week 82	—	118.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - System Blood Pressure Week 85	169.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	134.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - System Blood Pressure Week 88	—	116.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - System Blood Pressure Week 91	142.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	135.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - System Blood Pressure Week 94	148.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	136.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - System Blood Pressure Week 97	159.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	125.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - System Blood Pressure Week 100	165.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	120.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.

SECONDARY outcome

Timeframe: Overall study up to 24 months

Population: The Full Analysis Set consists of all subjects taking any amount of trial vaccine

Vital signs results assessed throughout the study.

Outcome measures

Outcome measures
Measure	CV301 + Atezolizumab (Cohort 1) n=19 Participants Cohort 1 - Combination of CV301 with atezolizumab in the first-line treatment of urothelia cancer not eligible for cisplatin-containing chemotherapy	CV301 + Atezolizumab (Cohort 2) n=24 Participants Cohort 2 - Combination of CV301 with atezolizumab in the second-line treatment of urothelia cancer previously treated with standard first-line cisplatin-based chemotherapy
Vital Signs Results - Diastolic Blood Pressure Week 37	83.0 mmHg Standard Deviation 1.41	81.0 mmHg Standard Deviation 10.44
Vital Signs Results - Diastolic Blood Pressure Week 40	68.0 mmHg Standard Deviation 7.21	70.0 mmHg Standard Deviation 8.72
Vital Signs Results - Diastolic Blood Pressure Week 43	69.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	76.0 mmHg Standard Deviation 1.00
Vital Signs Results - Diastolic Blood Pressure Week 73	—	79.5 mmHg Standard Deviation 14.85
Vital Signs Results - Diastolic Blood Pressure Week 76	—	67.5 mmHg Standard Deviation 4.95
Vital Signs Results - Diastolic Blood Pressure Week 79	69.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	72.5 mmHg Standard Deviation 2.12
Vital Signs Results - Diastolic Blood Pressure Week 82	—	60.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Diastolic Blood Pressure Week 91	61.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	83.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Diastolic Blood Pressure Week 94	66.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	62.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Diastolic Blood Pressure Week 100	69.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	72.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Diastolic Blood Pressure Baseline	68.3 mmHg Standard Deviation 8.39	74.4 mmHg Standard Deviation 9.33
Vital Signs Results - Diastolic Blood Pressure Week 4	67.4 mmHg Standard Deviation 7.18	70.5 mmHg Standard Deviation 9.08
Vital Signs Results - Diastolic Blood Pressure Week 7	70.0 mmHg Standard Deviation 8.42	71.8 mmHg Standard Deviation 9.58
Vital Signs Results - Diastolic Blood Pressure Week 10	71.3 mmHg Standard Deviation 10.06	71.6 mmHg Standard Deviation 8.75
Vital Signs Results - Diastolic Blood Pressure Week 13	74.0 mmHg Standard Deviation 8.43	73.0 mmHg Standard Deviation 6.86
Vital Signs Results - Diastolic Blood Pressure Week 16	70.4 mmHg Standard Deviation 8.26	74.7 mmHg Standard Deviation 8.67
Vital Signs Results - Diastolic Blood Pressure Week 19	68.0 mmHg Standard Deviation 5.34	68.8 mmHg Standard Deviation 10.57
Vital Signs Results - Diastolic Blood Pressure Week 22	72.6 mmHg Standard Deviation 9.58	64.2 mmHg Standard Deviation 10.82
Vital Signs Results - Diastolic Blood Pressure Week 25	73.0 mmHg Standard Deviation 6.08	73.8 mmHg Standard Deviation 9.81
Vital Signs Results - Diastolic Blood Pressure Week 28	64.3 mmHg Standard Deviation 10.02	74.8 mmHg Standard Deviation 5.89
Vital Signs Results - Diastolic Blood Pressure Week 31	71.7 mmHg Standard Deviation 7.51	76.0 mmHg Standard Deviation 8.19
Vital Signs Results - Diastolic Blood Pressure Week 34	67.3 mmHg Standard Deviation 5.03	74.7 mmHg Standard Deviation 2.52
Vital Signs Results - Diastolic Blood Pressure Week 46	80.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	82.7 mmHg Standard Deviation 3.21
Vital Signs Results - Diastolic Blood Pressure Week 49	69.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	76.7 mmHg Standard Deviation 3.51
Vital Signs Results - Diastolic Blood Pressure Week 52	73.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	74.0 mmHg Standard Deviation 10.00
Vital Signs Results - Diastolic Blood Pressure Week 55	64.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	82.5 mmHg Standard Deviation 9.19
Vital Signs Results - Diastolic Blood Pressure Week 58	—	78.5 mmHg Standard Deviation 4.95
Vital Signs Results - Diastolic Blood Pressure Week 61	56.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	76.5 mmHg Standard Deviation 7.78
Vital Signs Results - Diastolic Blood Pressure Week 64	70.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	73.5 mmHg Standard Deviation 3.54
Vital Signs Results - Diastolic Blood Pressure Week 67	—	73.5 mmHg Standard Deviation 0.71
Vital Signs Results - Diastolic Blood Pressure Week 70	81.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	71.5 mmHg Standard Deviation 2.12
Vital Signs Results - Diastolic Blood Pressure Week 85	71.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	77.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Diastolic Blood Pressure Week 88	—	78.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Diastolic Blood Pressure Week 97	72.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	66.0 mmHg Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.

SECONDARY outcome

Timeframe: Overall study up to 24 months

Population: The Full Analysis Set consists of all subjects taking any amount of trial vaccine

Vital signs results assessed throughout the study.

Outcome measures

Outcome measures
Measure	CV301 + Atezolizumab (Cohort 1) n=19 Participants Cohort 1 - Combination of CV301 with atezolizumab in the first-line treatment of urothelia cancer not eligible for cisplatin-containing chemotherapy	CV301 + Atezolizumab (Cohort 2) n=24 Participants Cohort 2 - Combination of CV301 with atezolizumab in the second-line treatment of urothelia cancer previously treated with standard first-line cisplatin-based chemotherapy
Vital Signs Results - Temperature Baseline	36.58 Celsius Standard Deviation 0.310	36.64 Celsius Standard Deviation 0.239
Vital Signs Results - Temperature Week 4	36.63 Celsius Standard Deviation 0.218	36.57 Celsius Standard Deviation 0.232
Vital Signs Results - Temperature Week 13	36.57 Celsius Standard Deviation 0.167	36.53 Celsius Standard Deviation 0.327
Vital Signs Results - Temperature Week 16	36.63 Celsius Standard Deviation 0.191	36.62 Celsius Standard Deviation 0.213
Vital Signs Results - Temperature Week 19	36.68 Celsius Standard Deviation 0.217	36.45 Celsius Standard Deviation 0.367
Vital Signs Results - Temperature Week 7	36.60 Celsius Standard Deviation 0.196	36.66 Celsius Standard Deviation 0.292
Vital Signs Results - Temperature Week 10	36.61 Celsius Standard Deviation 0.166	36.51 Celsius Standard Deviation 0.241
Vital Signs Results - Temperature Week 22	36.70 Celsius Standard Deviation 0.316	36.44 Celsius Standard Deviation 0.382
Vital Signs Results - Temperature Week 25	36.61 Celsius Standard Deviation 0.322	36.62 Celsius Standard Deviation 0.320
Vital Signs Results - Temperature Week 28	36.67 Celsius Standard Deviation 0.153	36.72 Celsius Standard Deviation 0.416
Vital Signs Results - Temperature Week 31	36.75 Celsius Standard Deviation 0.330	36.56 Celsius Standard Deviation 0.161
Vital Signs Results - Temperature Week 34	36.71 Celsius Standard Deviation 0.013	36.65 Celsius Standard Deviation 0.274
Vital Signs Results - Temperature Week 37	36.84 Celsius Standard Deviation 0.644	36.70 Celsius Standard Deviation 0.213
Vital Signs Results - Temperature Week 40	36.61 Celsius Standard Deviation 0.379	37.17 Celsius Standard Deviation 0.409
Vital Signs Results - Temperature Week 43	36.80 Celsius Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	36.86 Celsius Standard Deviation 0.076
Vital Signs Results - Temperature Week 46	36.80 Celsius Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	36.59 Celsius Standard Deviation 0.103
Vital Signs Results - Temperature Week 49	36.70 Celsius Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	36.79 Celsius Standard Deviation 0.135
Vital Signs Results - Temperature Week 52	36.90 Celsius Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	36.72 Celsius Standard Deviation 0.434
Vital Signs Results - Temperature Week 55	36.40 Celsius Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	36.53 Celsius Standard Deviation 0.189
Vital Signs Results - Temperature Week 58	—	36.66 Celsius Standard Deviation 0.063
Vital Signs Results - Temperature Week 61	36.60 Celsius Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	36.53 Celsius Standard Deviation 0.189
Vital Signs Results - Temperature Week 64	36.70 Celsius Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	36.64 Celsius Standard Deviation 0.196
Vital Signs Results - Temperature Week 67	—	36.60 Celsius Standard Deviation 0.141
Vital Signs Results - Temperature Week 70	36.80 Celsius Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	36.51 Celsius Standard Deviation 0.149
Vital Signs Results - Temperature Week 73	—	36.35 Celsius Standard Deviation 0.212
Vital Signs Results - Temperature Week 76	—	36.76 Celsius Standard Deviation 0.204
Vital Signs Results - Temperature Week 79	37.10 Celsius Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	36.12 Celsius Standard Deviation 0.456
Vital Signs Results - Temperature Week 82	—	36.70 Celsius Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Temperature Week 85	36.20 Celsius Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	36.30 Celsius Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Temperature Week 88	—	36.60 Celsius Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Temperature Week 91	36.40 Celsius Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	36.30 Celsius Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Temperature Week 94	36.60 Celsius Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	36.10 Celsius Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Temperature Week 97	36.70 Celsius Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	36.60 Celsius Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Temperature Week 100	36.90 Celsius Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	36.60 Celsius Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.

SECONDARY outcome

Timeframe: Overall study up to 24 months

Population: The Full Analysis Set consists of all subjects taking any amount of trial vaccine

Vital signs results assessed throughout the study.

Outcome measures

Adverse Events

CV301 + Atezolizumab (Cohort 1)

Serious events: 7 serious events

Other events: 18 other events

Deaths: 11 deaths

CV301 + Atezolizumab (Cohort 2)

Serious events: 5 serious events

Other events: 24 other events

Deaths: 15 deaths

Serious adverse events

Other adverse events

Additional Information

Bavarian Nordic Call Center

Bavarian Nordic A/S

Phone: 1-844-422-8274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Agreement entitles Bavarian Nordic to request the Institution(s) to delay their publication for a period of up to three (3) months from the date of the first submission to Bavarian Nordic.
Publication restrictions are in place

Restriction type: OTHER

Measure	CV301 + Atezolizumab (Cohort 1) n=19 Participants Cohort 1 - Combination of CV301 with atezolizumab in the first-line treatment of urothelia cancer not eligible for cisplatin-containing chemotherapy	CV301 + Atezolizumab (Cohort 2) n=24 Participants Cohort 2 - Combination of CV301 with atezolizumab in the second-line treatment of urothelia cancer previously treated with standard first-line cisplatin-based chemotherapy
Vital Signs Results - Respiratory Rate Week 40	16.7 breaths per minute Standard Deviation 1.15	16.0 breaths per minute Standard Deviation 0.00
Vital Signs Results - Respiratory Rate Week 43	18.0 breaths per minute Standard Deviation NA It is NA because it is not evaluable.	17.0 breaths per minute Standard Deviation 1.73
Vital Signs Results - Respiratory Rate Week 46	18.0 breaths per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	15.7 breaths per minute Standard Deviation 0.58
Vital Signs Results - Respiratory Rate Baseline	16.7 breaths per minute Standard Deviation 0.99	16.7 breaths per minute Standard Deviation 0.96
Vital Signs Results - Respiratory Rate Week 4	17.0 breaths per minute Standard Deviation 1.24	16.9 breaths per minute Standard Deviation 1.23
Vital Signs Results - Respiratory Rate Week 7	16.9 breaths per minute Standard Deviation 1.04	16.6 breaths per minute Standard Deviation 0.90
Vital Signs Results - Respiratory Rate Week 10	16.6 breaths per minute Standard Deviation 0.97	17.2 breaths per minute Standard Deviation 1.69
Vital Signs Results - Respiratory Rate Week 13	16.5 breaths per minute Standard Deviation 0.93	16.0 breaths per minute Standard Deviation 0.00
Vital Signs Results - Respiratory Rate Week 16	17.0 breaths per minute Standard Deviation 1.51	17.0 breaths per minute Standard Deviation 2.24
Vital Signs Results - Respiratory Rate Week 19	16.8 breaths per minute Standard Deviation 1.10	15.3 breaths per minute Standard Deviation 1.63
Vital Signs Results - Respiratory Rate Week 22	16.8 breaths per minute Standard Deviation 1.10	16.3 breaths per minute Standard Deviation 0.82
Vital Signs Results - Respiratory Rate Week 25	16.7 breaths per minute Standard Deviation 1.15	16.0 breaths per minute Standard Deviation 0.00
Vital Signs Results - Respiratory Rate Week 28	17.3 breaths per minute Standard Deviation 2.31	16.2 breaths per minute Standard Deviation 0.45
Vital Signs Results - Respiratory Rate Week 31	16.7 breaths per minute Standard Deviation 1.15	16.0 breaths per minute Standard Deviation 0.00
Vital Signs Results - Respiratory Rate Week 34	18.0 breaths per minute Standard Deviation 0.00	16.7 breaths per minute Standard Deviation 1.15
Vital Signs Results - Respiratory Rate Week 37	17.0 breaths per minute Standard Deviation 1.41	15.3 breaths per minute Standard Deviation 1.15
Vital Signs Results - Respiratory Rate Week 49	18.0 breaths per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	15.7 breaths per minute Standard Deviation 0.58
Vital Signs Results - Respiratory Rate Week 52	18.0 breaths per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	16.7 breaths per minute Standard Deviation 1.15
Vital Signs Results - Respiratory Rate Week 55	18.0 breaths per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	16.0 breaths per minute Standard Deviation 0.00
Vital Signs Results - Respiratory Rate Week 58	—	17.0 breaths per minute Standard Deviation 1.41
Vital Signs Results - Respiratory Rate Week 61	18.0 breaths per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	16.0 breaths per minute Standard Deviation 0.00
Vital Signs Results - Respiratory Rate Week 64	18.0 breaths per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	16.0 breaths per minute Standard Deviation 0.00
Vital Signs Results - Respiratory Rate Week 67	—	16.5 breaths per minute Standard Deviation 0.71
Vital Signs Results - Respiratory Rate Week 70	18.0 breaths per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	17.0 breaths per minute Standard Deviation 1.41
Vital Signs Results - Respiratory Rate Week 73	—	17.0 breaths per minute Standard Deviation 1.41
Vital Signs Results - Respiratory Rate Week 76	—	16.0 breaths per minute Standard Deviation 0.00
Vital Signs Results - Respiratory Rate Week 79	18.0 breaths per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	17.0 breaths per minute Standard Deviation 1.41
Vital Signs Results - Respiratory Rate Week 82	—	16.0 breaths per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Respiratory Rate Week 85	18.0 breaths per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	18.0 breaths per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Respiratory Rate Week 88	—	16.0 breaths per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Respiratory Rate Week 91	17.0 breaths per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	16.0 breaths per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Respiratory Rate Week 94	18.0 breaths per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	16.0 breaths per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Respiratory Rate Week 97	16.0 breaths per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	18.0 breaths per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.
Vital Signs Results - Respiratory Rate Week 100	18.0 breaths per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.	16.0 breaths per minute Standard Deviation NA It is NA because it is not evaluable. Standard deviation not calculated when \<2 participants were analyzed.

Serious adverse events
Measure	CV301 + Atezolizumab (Cohort 1) n=19 participants at risk Combination of CV301 with atezolizumab in the first-line treatment of urothelia cancer not eligible for cisplatin-containing chemotherapy	CV301 + Atezolizumab (Cohort 2) n=24 participants at risk Combination of CV301 with atezolizumab in the second-line treatment of urothelia cancer previously treated with standard first-line cisplatin-based chemotherapy
Gastrointestinal disorders Abdominal pain	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/19 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	4.2% 1/24 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Gastrointestinal disorders Large intestinal obstruction	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/19 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	4.2% 1/24 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Metabolism and nutrition disorders Dehydration	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Metabolism and nutrition disorders Fluid overload	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/19 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	4.2% 1/24 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Renal and urinary disorders Acute kidney injury	15.8% 3/19 • Number of events 3 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Infections and infestations Urinary tract infection	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	4.2% 1/24 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Investigations Activated partial thromboplastin time prolonged	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Investigations Blood bilirubin increased	0.00% 0/19 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	4.2% 1/24 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Investigations Neutrophil count decreased	0.00% 0/19 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	4.2% 1/24 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Investigations Platelet count decreased	0.00% 0/19 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	4.2% 1/24 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Psychiatric disorders Confusional state	10.5% 2/19 • Number of events 2 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Psychiatric disorders Delirium	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/19 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	4.2% 1/24 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Blood and lymphatic system disorders Anaemia	0.00% 0/19 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	4.2% 1/24 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Cardiac disorders Cardiac arrest	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
General disorders Pyrexia	0.00% 0/19 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	4.2% 1/24 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/19 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	4.2% 1/24 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Vascular disorders Hypotension	0.00% 0/19 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	4.2% 1/24 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.

Other adverse events
Measure	CV301 + Atezolizumab (Cohort 1) n=19 participants at risk Combination of CV301 with atezolizumab in the first-line treatment of urothelia cancer not eligible for cisplatin-containing chemotherapy	CV301 + Atezolizumab (Cohort 2) n=24 participants at risk Combination of CV301 with atezolizumab in the second-line treatment of urothelia cancer previously treated with standard first-line cisplatin-based chemotherapy
Gastrointestinal disorders Diarrhoea	21.1% 4/19 • Number of events 6 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	16.7% 4/24 • Number of events 4 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Gastrointestinal disorders Nausea	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	25.0% 6/24 • Number of events 7 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Gastrointestinal disorders Constipation	10.5% 2/19 • Number of events 2 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	16.7% 4/24 • Number of events 4 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Gastrointestinal disorders Vomiting	10.5% 2/19 • Number of events 2 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	16.7% 4/24 • Number of events 5 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Gastrointestinal disorders Adominal pain	15.8% 3/19 • Number of events 3 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	8.3% 2/24 • Number of events 2 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Gastrointestinal disorders Dry mouth	0.00% 0/19 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	8.3% 2/24 • Number of events 2 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Gastrointestinal disorders Abdominal discomfort	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Gastrointestinal disorders Flatulence	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
General disorders Fatigue	42.1% 8/19 • Number of events 9 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	33.3% 8/24 • Number of events 10 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
General disorders Injection site pain	10.5% 2/19 • Number of events 2 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	33.3% 8/24 • Number of events 14 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
General disorders Pyrexia	10.5% 2/19 • Number of events 2 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	25.0% 6/24 • Number of events 7 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
General disorders Chills	15.8% 3/19 • Number of events 4 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	16.7% 4/24 • Number of events 4 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
General disorders Injection site erythema	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	25.0% 6/24 • Number of events 12 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
General disorders Injection site swelling	10.5% 2/19 • Number of events 2 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	16.7% 4/24 • Number of events 5 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
General disorders Influenza like illness	0.00% 0/19 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	16.7% 4/24 • Number of events 4 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
General disorders Injection site mass	0.00% 0/19 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	12.5% 3/24 • Number of events 7 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
General disorders Injection site reaction	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	8.3% 2/24 • Number of events 2 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
General disorders Injection site discomfort	0.00% 0/19 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	8.3% 2/24 • Number of events 2 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
General disorders Chest discomfort	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
General disorders Infusion site uriticaria	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
General disorders Injection site inflammation	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
General disorders Injection site irritation	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
General disorders Injection site warmth	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
General disorders Nodule	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Gastrointestinal disorders Gastroesophageal reflux disease	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Musculoskeletal and connective tissue disorders Back pain	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	20.8% 5/24 • Number of events 5 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Musculoskeletal and connective tissue disorders Arthralgia	10.5% 2/19 • Number of events 2 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	12.5% 3/24 • Number of events 3 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/19 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	8.3% 2/24 • Number of events 2 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Musculoskeletal and connective tissue disorders Muscular weaness	10.5% 2/19 • Number of events 2 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Musculoskeletal and connective tissue disorders Flank pain	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Musculoskeletal and connective tissue disorders Groin pain	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Musculoskeletal and connective tissue disorders Neck pain	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Musculoskeletal and connective tissue disorders Trigger finger	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/19 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	20.8% 5/24 • Number of events 5 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/19 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	20.8% 5/24 • Number of events 5 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/19 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	12.5% 3/24 • Number of events 3 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	10.5% 2/19 • Number of events 2 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	5.3% 1/19 • Number of events 1 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.	0.00% 0/24 • All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product, up to 24 months. All Adverse events collected from the signing of inform consent form to 30 days after the last dose of trial product, if unrelated to trial product or non-serious, and all trial product-related SAEs and AESI collected through 100 days after the last dose of trial product.