Bladder Cancer
Conditions
Brief summary
This is a Phase 2, single-arm, multi-institutional clinical trial designed to study the combination of CV301 with atezolizumab in the first-line treatment of UC not eligible for cisplatin-containing chemotherapy (Cohort 1) and in the second-line treatment of UC previously treated with standard first-line cisplatin-based chemotherapy (Cohort 2).
Detailed description
This is a Phase 2, single-arm, multi-institutional clinical trial designed to study the combination of CV301 with atezolizumab in the first-line treatment of UC not eligible for cisplatin-containing chemotherapy (Cohort 1) and in the second-line treatment of UC previously treated with standard first-line cisplatin-based chemotherapy (Cohort 2). The trial will be performed using an optimal two-stage design within each cohort. Stage 1, Cohort 1: Enroll 14 subjects. If objective response is not achieved in at least four patients, the cohort will be stopped for futility. If objective response is achieved in at least four subjects, the cohort will proceed to stage 2. If any patient is not evaluable for the primary endpoint, the patient may be replaced. Stage 1, Cohort 2: Enroll 13 subjects. If objective response is not achieved in at least three patients, the cohort will be stopped for futility. If objective response is achieved in at least three subjects, the cohort will proceed to stage 2. If any patient is not evaluable for the primary endpoint, the patient may be replaced. Stage 2, Cohort 1: Enroll an additional 19 subjects. If any patient is not evaluable for the primary endpoint, the patient may be replaced until a total of 33 patients are evaluable for the primary endpoint. Stage 2, Cohort 2: Enroll an additional 22 subjects. If any patient is not evaluable for the primary endpoint, the patient may be replaced until a total of 35 patients are evaluable for the primary endpoint.
Interventions
BIOLOGICALCV301
Prime with MVA-BN-CV301 (nominal titer 1.6 x 10\^9 Inf.U) given subcutaneously (SC) on Day 1 and Day 22. One dose = four 0.5 mL injections. One injection = nominal titer 4 x 10\^8 Inf.U in 0.5 mL. Boost with FPV-CV301 (nominal titer of 1 × 10\^9 Inf.U in 0.5 mL, given SC every 21 days for 4 doses (on days 43, 64, 85, and 106), followed by boosts every 6 weeks until 6 months on trial (i.e., days 148 and 190), then every 12 weeks until completion of 2 years. One dose = one 0.5 mL injection.
BIOLOGICALAtezolizumab
Atezolizumab fixed dose of 1200 mg intravenous on Day 1 of each 21-day cycle
Sponsors
Bavarian Nordic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years at date of ICF signature having the ability to comply with protocol. 2. Histologically or cytologically documented locally advanced (T4b, any N; or any T, N 2-3) or metastatic (M1, Stage IV; or metastatic recurrence after locoregional treatment) UC (including renal pelvis, ureters, urinary bladder, urethra) 1. Patients with mixed histologies were required to have a dominant transitional cell pattern. 2. Locally advanced bladder cancer that was inoperable on the basis of involvement of the pelvic sidewall or adjacent viscera (clinical stage T4b) or bulky nodal metastasis (N2-N3). 3. Life expectancy ≥ 12 weeks. 4. Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions cannot be counted as target lesions unless there has been demonstrated progression in the lesion since radiotherapy and no other lesions are available for selection as target lesions. 5. Demonstrate adequate organ function. 6. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate \[\< 1% per year\] when used consistently and correctly) and to continue its use for 5 months after the last dose of atezolizumab. 7. Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks preferred) or 10-15 unstained slides, with an associated pathology report. For Cohort 1: 8. Untreated with chemotherapy 9. Have at least one of the following: 1. ECOG (Eastern Cooperative Oncology Group) performance status of 2. 2. Glomerular filtration rate calculated as creatinine clearance (Cockroft-Gault formula) of ≥20 mL/min and less than 60 mL/min 3. Hearing loss or neuropathy of any cause Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 For Cohort 2: 10. Disease progression during or following treatment with at least one platinum-containing regimen (e.g., GC, MVAC, CarboGem, carboplatin-paclitaxel) for inoperable locally advanced or metastatic urothelial carcinoma or disease recurrence, as defined by: 1. Regimen is defined as patients receiving at least one cycle of a platinum-containing regimen with response assessment. Patients who received one cycle of a platinum-containing regimen but discontinued due to toxicity are also eligible. 2. Patients who received prior adjuvant/neoadjuvant chemotherapy and progressed within 12 months of treatment with a platinum-containing adjuvant/neoadjuvant regimen are considered as second-line patients. 11. ECOG (Eastern Cooperative Oncology Group) performance status of \< 2 12. Calculated creatinine clearance (Cockroft-Gault formula) of ≥20 mL/min
Exclusion criteria
1. Any approved anti-cancer therapy, including chemotherapy, within 3 weeks prior to initiation of trial treatment; the following exceptions are allowed: 1. Palliative radiotherapy for bone metastases or non-target soft tissue lesions completed \>7 days prior to baseline imaging. 2. Hormone-replacement therapy or oral contraceptives. 2. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to screening given that all AEs related to prior treatment have resolved to baseline or Grade 1. 3. Active central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments or Leptomeningeal disease. 4. Uncontrolled tumor-related pain: 1. Patients requiring pain medication must be on a stable regimen at trial entry. 2. Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastases causing nerve impingement) should be treated prior to trial entry. 3. Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not currently associated with spinal cord compression) could be considered for loco-regional therapy if appropriate prior to enrollment. 5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) a. Patients with indwelling catheters (e.g., PleurX) are allowed. 6. Uncontrolled hypercalcemia (\>1.5 mmol/L ionized calcium or Ca \>12 mg/dL or corrected serum calcium \>ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab: 1. Patients who are receiving bisphosphonate therapy or denosumab specifically to prevent skeletal events and who did not have a history of clinically significant hypercalcemia are eligible. 2. Patients who are receiving denosumab prior to enrollment have to be willing and eligible to receive a bisphosphonate instead while in the trial. 7. Malignancies other than urothelial carcinoma within 3 years prior to Day 1, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) or localized prostate cancer treated with curative intent and no intent for further treatment or incidental prostate cancer (T1/T2b, Gleason score ≤7 undergoing active surveillance and treatment naive). 8. Pregnant and lactating women. 9. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, or aminoglycoside antibiotics or egg products, poxvirus-based vaccinations, or beef or bovine meat. 10. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation. 11. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, granulomatosis with polyangiitis, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. 1. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible for this trial. 2. Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen are eligible for this trial. 3. Patients with history of vitiligo and controlled psoriasis are eligible for the trial. 12. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan a. History of radiation pneumonitis in the radiation field (fibrosis) is permitted. 13. Positive test for Human Immunodeficiency Virus (HIV). 14. Patients with active hepatitis B virus (HBV; chronic or acute, defined as having a positive hepatitis B surface antigen \[HBsAg\] test at screening) or hepatitis C virus (HCV) 1. Patients with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody \[HBcAb\] and absence of HbsAg, negative polymerase chain reaction (PCR) for HBV) are eligible. HBV Deoxyribonucleic Acid (DNA) PCR must be obtained in these patients prior to Day 1. 2. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV Ribonucleic Acid (RNA) prior to enrollment. 15. Active tuberculosis. 16. Signs or symptoms clinically significant of infection within 2 weeks prior to Day 1. 17. Received therapeutic oral or intravenous (IV) antibiotics within 1 week prior to Day 1 a. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or to prevent chronic obstructive pulmonary disease exacerbation) are eligible. 18. Significant cardiovascular disease, which includes but is not limited to New York Heart Association (NYHA) Heart Failure Class II or greater, myocardial infarction within the previous 3 months, unstable arrhythmias, unstable angina. a. Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction \< 50% on a stable medical regimen that was optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate, are eligible. 19. Major surgical procedure other than for diagnosis within 28 days prior to Day 1 or anticipation of need for a major surgical procedure during the course of the trial. 20. Prior allogeneic stem cell or solid organ transplant. 21. Administration of a live, attenuated vaccine within 4 weeks before Day 1 or anticipation that such a live attenuated vaccine would be required during the trial a. Influenza vaccination may be given during influenza season only (approximately October to March). Patients cannot receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to Day 1 or at any time during the trial. 22. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or that could affect the interpretation of the results or render the patient at high risk from treatment complications. 23. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies 24. Treatment with systemic immunostimulatory agents (including but not limited to IFNs, interleukin \[IL\]-2) within 6 weeks or five half-lives of the drug, whichever was shorter, prior to Day 1. 25. Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial a. Patients who receive acute, low-dose, systemic corticosteroid medications (e.g., a one-time dose of dexamethasone for nausea) or for prevention of hypersensitivity reactions to contrast agents may be enrolled in the trial. 26. The use of inhaled, nasal, ophthalmic, intra-articular, auricular or topical corticosteroids, physiologic replacement doses of glucocorticoids (i.e., for adrenal insufficiency), and mineralocorticoids (e.g. Fludrocortisone for adrenal insufficiency) is allowed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | up to 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 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. | 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. |
| Duration of Response | up to 24 months | The time from objective response (CR or PR, whichever comes first) to investigator assessed progression using RECIST v1.1 or death |
| Treatment-Emergent Adverse Events | up to 24 months | 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. |
| Toxicity Grade Shift From Baseline in Laboratory Results | Overall Study up to 24 months | 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). |
| Progression Free Survival (PFS) | 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. | 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. |
| Vital Signs Results - System Blood Pressure | Overall study up to 24 months | Vital signs results assessed throughout the study. |
| Vital Signs Results - Diastolic Blood Pressure | Overall study up to 24 months | Vital signs results assessed throughout the study. |
| Vital Signs Results - Temperature | Overall study up to 24 months | Vital signs results assessed throughout the study. |
| Vital Signs Results - Respiratory Rate | Overall study up to 24 months | Vital signs results assessed throughout the study. |
| Vital Signs Results - Pulse Rate | Overall study up to 24 months | Vital signs results assessed throughout the study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 19 |
| 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 | 24 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lack of Efficacy | 15 | 20 |
| Overall Study | Study Terminated by Sponsor | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | CV301 + Atezolizumab (Cohort 1) | CV301 + Atezolizumab (Cohort 2) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 19 Participants | 16 Participants | 35 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 8 Participants | 8 Participants |
| Age, Continuous | 79.0 years STANDARD_DEVIATION 5.97 | 66.8 years STANDARD_DEVIATION 10.99 | 72.2 years STANDARD_DEVIATION 10.91 |
| Baseline PD-L1 Expression Tumor Proportion Score <1% | 3 Participants | 2 Participants | 5 Participants |
| Baseline PD-L1 Expression Tumor Proportion Score >=10% | 0 Participants | 0 Participants | 0 Participants |
| Baseline PD-L1 Expression Tumor Proportion Score >=1%-1<10% | 0 Participants | 2 Participants | 2 Participants |
| Baseline PD-L1 Expression Tumor Proportion Score Not Applicable | 16 Participants | 20 Participants | 36 Participants |
| ECOG Status Grade 0 | 10 Participants | 12 Participants | 22 Participants |
| ECOG Status Grade 1 | 8 Participants | 11 Participants | 19 Participants |
| ECOG Status Grade >=2 | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 23 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| M Category M0 | 10 Participants | 10 Participants | 20 Participants |
| M Category M1 | 8 Participants | 14 Participants | 22 Participants |
| M Category Not Reported | 1 Participants | 0 Participants | 1 Participants |
| N Category N0 | 11 Participants | 10 Participants | 21 Participants |
| N Category N1 | 3 Participants | 3 Participants | 6 Participants |
| N Category N2 | 1 Participants | 7 Participants | 8 Participants |
| N Category N3 | 1 Participants | 1 Participants | 2 Participants |
| N Category NX | 3 Participants | 3 Participants | 6 Participants |
| Primary Tumor Site Renal Pelvis | 4 Participants | 0 Participants | 4 Participants |
| Primary Tumor Site Ureter | 1 Participants | 0 Participants | 1 Participants |
| Primary Tumor Site Urethra | 1 Participants | 3 Participants | 4 Participants |
| Primary Tumor Site Urinary Bladder | 13 Participants | 21 Participants | 34 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 23 Participants | 42 Participants |
| Region of Enrollment United States | 19 Participants | 24 Participants | 43 Participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 16 Participants | 19 Participants | 35 Participants |
| Stage at Diagnosis Stage I | 7 Participants | 3 Participants | 10 Participants |
| Stage at Diagnosis Stage II | 1 Participants | 1 Participants | 2 Participants |
| Stage at Diagnosis Stage III | 4 Participants | 4 Participants | 8 Participants |
| Stage at Diagnosis Stage IV | 7 Participants | 16 Participants | 23 Participants |
| T Category T0 | 0 Participants | 0 Participants | 0 Participants |
| T Category T1 | 4 Participants | 7 Participants | 11 Participants |
| T Category T2a | 0 Participants | 1 Participants | 1 Participants |
| T Category T2b | 2 Participants | 1 Participants | 3 Participants |
| T Category T3a | 2 Participants | 1 Participants | 3 Participants |
| T Category T3b | 2 Participants | 4 Participants | 6 Participants |
| T Category T4a | 0 Participants | 2 Participants | 2 Participants |
| T Category T4b | 1 Participants | 1 Participants | 2 Participants |
| T Category Ta | 3 Participants | 2 Participants | 5 Participants |
| T Category Tis | 1 Participants | 1 Participants | 2 Participants |
| T Category TX | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 11 / 19 | 15 / 24 |
| other Total, other adverse events | 18 / 19 | 24 / 24 |
| serious Total, serious adverse events | 7 / 19 | 5 / 24 |
Outcome results
Primary
Objective Response Rate (ORR)
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.
Time frame: up to 24 months
Population: Full Analysis Set subjects with objective response
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CV301 + Atezolizumab (Cohort 1) | Objective Response Rate (ORR) | 1 Participants |
| CV301 + Atezolizumab (Cohort 2) | Objective Response Rate (ORR) | 2 Participants |
Secondary
Duration of Response
The time from objective response (CR or PR, whichever comes first) to investigator assessed progression using RECIST v1.1 or death
Time frame: up to 24 months
Population: Full Analysis Set subjects with objective response
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CV301 + Atezolizumab (Cohort 1) | Duration of Response | NA Months |
| CV301 + Atezolizumab (Cohort 2) | Duration of Response | NA Months |
Secondary
Overall Survival (OS)
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.
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CV301 + Atezolizumab (Cohort 1) | Overall Survival (OS) | 13.8 Months |
| CV301 + Atezolizumab (Cohort 2) | Overall Survival (OS) | 8.13 Months |
Secondary
Progression Free Survival (PFS)
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.
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CV301 + Atezolizumab (Cohort 1) | Progression Free Survival (PFS) | 2 Months |
| CV301 + Atezolizumab (Cohort 2) | Progression Free Survival (PFS) | 1.95 Months |
Secondary
Toxicity Grade Shift From Baseline in Laboratory Results
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).
Time frame: Overall Study up to 24 months
Population: The Full Analysis Set consists of all subjects taking any amount of trial vaccine
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Leukocytes >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Bicarbonate <= Grade 2 | 18 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Platelets >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Bicarbonate >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Eosinophils >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Bilirubin <= Grade 2 | 17 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Alanine Aminotransferase <= Grade 2 | 18 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Bilirubin >= Grade 3 | 1 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Lymphocytes <= Grade 2 | 16 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Calcium <= Grade 2 | 18 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Alanine Aminotransferase >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Calcium >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Hemoglobin >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Creatinine <= Grade 2 | 16 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Albumin <= Grade 2 | 18 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Creatinine >= Grade 3 | 2 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Lymphocytes >= Grade 3 | 2 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Glucose <= Grade 2 | 18 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Albumin >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Glucose >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Lactate Dehydrogenase <= Grade 2 | 18 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Eosinophils <= Grade 2 | 18 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Lactate Dehydrogenase >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Alkaline Phosphatase <= Grade 2 | 18 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Lipase <= Grade 2 | 15 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Neutrophils <= Grade 2 | 18 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Lipase >= Grade 3 | 3 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Alkaline Phosphatase >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Potassium <= Grade 2 | 18 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Leukocytes <= Grade 2 | 18 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Potassium >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Amylase <= Grade 2 | 17 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Sodium <= Grade 2 | 18 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Neutrophils >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Sodium >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Amylase >= Grade 3 | 1 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Thyrotropin <= Grade 2 | 13 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Hemoglobin <= Grade 2 | 18 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Thyrotropin >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Aspartate Aminotransferase <= Grade 2 | 18 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Urate <= Grade 2 | 12 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Platelets <= Grade 2 | 18 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Urate >= Grade 3 | 6 Participants |
| CV301 + Atezolizumab (Cohort 1) | Toxicity Grade Shift From Baseline in Laboratory Results | Aspartate Aminotransferase >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Urate >= Grade 3 | 3 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Eosinophils <= Grade 2 | 24 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Eosinophils >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Hemoglobin <= Grade 2 | 24 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Hemoglobin >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Leukocytes <= Grade 2 | 24 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Leukocytes >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Lymphocytes <= Grade 2 | 22 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Lymphocytes >= Grade 3 | 2 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Neutrophils <= Grade 2 | 24 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Neutrophils >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Platelets <= Grade 2 | 24 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Platelets >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Alanine Aminotransferase <= Grade 2 | 24 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Alanine Aminotransferase >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Albumin <= Grade 2 | 24 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Albumin >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Alkaline Phosphatase <= Grade 2 | 24 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Alkaline Phosphatase >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Amylase <= Grade 2 | 24 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Amylase >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Aspartate Aminotransferase <= Grade 2 | 24 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Aspartate Aminotransferase >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Bicarbonate <= Grade 2 | 24 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Bicarbonate >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Bilirubin <= Grade 2 | 24 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Bilirubin >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Calcium <= Grade 2 | 24 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Calcium >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Creatinine <= Grade 2 | 24 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Creatinine >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Glucose <= Grade 2 | 24 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Lactate Dehydrogenase <= Grade 2 | 24 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Lactate Dehydrogenase >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Lipase <= Grade 2 | 23 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Lipase >= Grade 3 | 1 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Potassium <= Grade 2 | 24 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Potassium >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Sodium <= Grade 2 | 22 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Sodium >= Grade 3 | 2 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Thyrotropin <= Grade 2 | 18 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Thyrotropin >= Grade 3 | 0 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Urate <= Grade 2 | 21 Participants |
| CV301 + Atezolizumab (Cohort 2) | Toxicity Grade Shift From Baseline in Laboratory Results | Glucose >= Grade 3 | 0 Participants |
Secondary
Treatment-Emergent Adverse Events
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.
Time frame: up to 24 months
Population: The Full Analysis Set consists of all subjects taking any amount of trial vaccine
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CV301 + Atezolizumab (Cohort 1) | Treatment-Emergent Adverse Events | Treatment Emergent Adverse Events | 19 Participants |
| CV301 + Atezolizumab (Cohort 1) | Treatment-Emergent Adverse Events | Related Adverse Events | 16 Participants |
| CV301 + Atezolizumab (Cohort 1) | Treatment-Emergent Adverse Events | >= Grade 3 Adverse Events | 10 Participants |
| CV301 + Atezolizumab (Cohort 1) | Treatment-Emergent Adverse Events | Related >= Grade 3 Adverse Events | 5 Participants |
| CV301 + Atezolizumab (Cohort 1) | Treatment-Emergent Adverse Events | Serious Adverse Events | 7 Participants |
| CV301 + Atezolizumab (Cohort 1) | Treatment-Emergent Adverse Events | Related Serious Adverse Events | 0 Participants |
| CV301 + Atezolizumab (Cohort 1) | Treatment-Emergent Adverse Events | Adverse Events of Special Interest | 1 Participants |
| CV301 + Atezolizumab (Cohort 1) | Treatment-Emergent Adverse Events | Related Adverse Events of Special Interest | 0 Participants |
| CV301 + Atezolizumab (Cohort 2) | Treatment-Emergent Adverse Events | Related Adverse Events of Special Interest | 1 Participants |
| CV301 + Atezolizumab (Cohort 2) | Treatment-Emergent Adverse Events | Treatment Emergent Adverse Events | 24 Participants |
| CV301 + Atezolizumab (Cohort 2) | Treatment-Emergent Adverse Events | Serious Adverse Events | 5 Participants |
| CV301 + Atezolizumab (Cohort 2) | Treatment-Emergent Adverse Events | Related Adverse Events | 21 Participants |
| CV301 + Atezolizumab (Cohort 2) | Treatment-Emergent Adverse Events | Adverse Events of Special Interest | 1 Participants |
| CV301 + Atezolizumab (Cohort 2) | Treatment-Emergent Adverse Events | >= Grade 3 Adverse Events | 12 Participants |
| CV301 + Atezolizumab (Cohort 2) | Treatment-Emergent Adverse Events | Related Serious Adverse Events | 1 Participants |
| CV301 + Atezolizumab (Cohort 2) | Treatment-Emergent Adverse Events | Related >= Grade 3 Adverse Events | 4 Participants |
Secondary
Vital Signs Results - Diastolic Blood Pressure
Vital signs results assessed throughout the study.
Time frame: Overall study up to 24 months
Population: The Full Analysis Set consists of all subjects taking any amount of trial vaccine
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 52 | 73.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 28 | 64.3 mmHg | Standard Deviation 10.02 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 55 | 64.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 16 | 70.4 mmHg | Standard Deviation 8.26 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 31 | 71.7 mmHg | Standard Deviation 7.51 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 61 | 56.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 10 | 71.3 mmHg | Standard Deviation 10.06 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 64 | 70.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 34 | 67.3 mmHg | Standard Deviation 5.03 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 19 | 68.0 mmHg | Standard Deviation 5.34 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 70 | 81.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 37 | 83.0 mmHg | Standard Deviation 1.41 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 7 | 70.0 mmHg | Standard Deviation 8.42 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 40 | 68.0 mmHg | Standard Deviation 7.21 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 79 | 69.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 22 | 72.6 mmHg | Standard Deviation 9.58 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 43 | 69.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 85 | 71.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 13 | 74.0 mmHg | Standard Deviation 8.43 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 46 | 80.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 91 | 61.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 25 | 73.0 mmHg | Standard Deviation 6.08 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 94 | 66.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 49 | 69.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 97 | 72.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 4 | 67.4 mmHg | Standard Deviation 7.18 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Week 100 | 69.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Diastolic Blood Pressure | Baseline | 68.3 mmHg | Standard Deviation 8.39 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 82 | 60.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 85 | 77.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 88 | 78.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 91 | 83.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 94 | 62.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 97 | 66.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 100 | 72.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Baseline | 74.4 mmHg | Standard Deviation 9.33 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 4 | 70.5 mmHg | Standard Deviation 9.08 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 7 | 71.8 mmHg | Standard Deviation 9.58 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 10 | 71.6 mmHg | Standard Deviation 8.75 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 13 | 73.0 mmHg | Standard Deviation 6.86 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 16 | 74.7 mmHg | Standard Deviation 8.67 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 19 | 68.8 mmHg | Standard Deviation 10.57 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 22 | 64.2 mmHg | Standard Deviation 10.82 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 25 | 73.8 mmHg | Standard Deviation 9.81 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 28 | 74.8 mmHg | Standard Deviation 5.89 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 31 | 76.0 mmHg | Standard Deviation 8.19 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 34 | 74.7 mmHg | Standard Deviation 2.52 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 37 | 81.0 mmHg | Standard Deviation 10.44 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 40 | 70.0 mmHg | Standard Deviation 8.72 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 43 | 76.0 mmHg | Standard Deviation 1 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 46 | 82.7 mmHg | Standard Deviation 3.21 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 49 | 76.7 mmHg | Standard Deviation 3.51 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 52 | 74.0 mmHg | Standard Deviation 10 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 55 | 82.5 mmHg | Standard Deviation 9.19 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 58 | 78.5 mmHg | Standard Deviation 4.95 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 61 | 76.5 mmHg | Standard Deviation 7.78 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 64 | 73.5 mmHg | Standard Deviation 3.54 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 67 | 73.5 mmHg | Standard Deviation 0.71 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 70 | 71.5 mmHg | Standard Deviation 2.12 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 73 | 79.5 mmHg | Standard Deviation 14.85 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 76 | 67.5 mmHg | Standard Deviation 4.95 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Diastolic Blood Pressure | Week 79 | 72.5 mmHg | Standard Deviation 2.12 |
Secondary
Vital Signs Results - Pulse Rate
Vital signs results assessed throughout the study.
Time frame: Overall study up to 24 months
Population: The Full Analysis Set consists of all subjects taking any amount of trial vaccine
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 52 | 75.0 beats per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 13 | 73.6 beats per minute | Standard Deviation 11.45 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 55 | 79.0 beats per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 28 | 57.3 beats per minute | Standard Deviation 5.51 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 7 | 70.2 beats per minute | Standard Deviation 12.06 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 61 | 68.0 beats per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 31 | 64.0 beats per minute | Standard Deviation 11.14 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 64 | 81.0 beats per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 16 | 66.5 beats per minute | Standard Deviation 5.58 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 34 | 67.3 beats per minute | Standard Deviation 13.58 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 70 | 80.0 beats per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 4 | 72.7 beats per minute | Standard Deviation 11.49 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 37 | 76.5 beats per minute | Standard Deviation 30.41 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 19 | 66.4 beats per minute | Standard Deviation 11.01 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 79 | 77.0 beats per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 10 | 66.8 beats per minute | Standard Deviation 8.84 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 43 | 68.0 beats per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 85 | 80.0 beats per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 22 | 72.2 beats per minute | Standard Deviation 16.95 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 46 | 69.0 beats per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 91 | 58.0 beats per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Baseline | 76.4 beats per minute | Standard Deviation 13.41 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 94 | 83.0 beats per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 49 | 93.0 beats per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 97 | 63.0 beats per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 25 | 68.7 beats per minute | Standard Deviation 17.56 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 100 | 64.0 beats per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Pulse Rate | Week 40 | 67.0 beats per minute | Standard Deviation 14.11 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 82 | 73.0 beats per minute | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 85 | 66.0 beats per minute | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 88 | 77.0 beats per minute | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 91 | 69.0 beats per minute | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 94 | 84.0 beats per minute | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 97 | 81.0 beats per minute | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 100 | 93.0 beats per minute | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Baseline | 75.3 beats per minute | Standard Deviation 15.31 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 4 | 79.4 beats per minute | Standard Deviation 17.61 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 7 | 76.5 beats per minute | Standard Deviation 15.56 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 10 | 79.5 beats per minute | Standard Deviation 17.06 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 13 | 75.0 beats per minute | Standard Deviation 18.46 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 16 | 76.7 beats per minute | Standard Deviation 15.74 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 19 | 76.2 beats per minute | Standard Deviation 17.49 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 22 | 71.7 beats per minute | Standard Deviation 18.04 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 25 | 83.0 beats per minute | Standard Deviation 13.73 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 28 | 83.4 beats per minute | Standard Deviation 23.95 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 31 | 86.0 beats per minute | Standard Deviation 14.73 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 34 | 74.7 beats per minute | Standard Deviation 8.08 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 37 | 80.0 beats per minute | Standard Deviation 10.15 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 40 | 84.7 beats per minute | Standard Deviation 13.32 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 43 | 85.3 beats per minute | Standard Deviation 17.21 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 46 | 91.7 beats per minute | Standard Deviation 11.37 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 49 | 80.0 beats per minute | Standard Deviation 6.93 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 52 | 94.7 beats per minute | Standard Deviation 17.5 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 55 | 74.0 beats per minute | Standard Deviation 7.07 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 58 | 75.5 beats per minute | Standard Deviation 0.71 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 61 | 77.5 beats per minute | Standard Deviation 10.61 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 64 | 81.0 beats per minute | Standard Deviation 1.41 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 67 | 81.0 beats per minute | Standard Deviation 2.83 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 70 | 73.0 beats per minute | Standard Deviation 5.66 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 73 | 72.0 beats per minute | Standard Deviation 9.9 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 76 | 85.0 beats per minute | Standard Deviation 5.66 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Pulse Rate | Week 79 | 76.0 beats per minute | Standard Deviation 12.73 |
Secondary
Vital Signs Results - Respiratory Rate
Vital signs results assessed throughout the study.
Time frame: Overall study up to 24 months
Population: The Full Analysis Set consists of all subjects taking any amount of trial vaccine
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 52 | 18.0 breaths per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 28 | 17.3 breaths per minute | Standard Deviation 2.31 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 55 | 18.0 breaths per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 16 | 17.0 breaths per minute | Standard Deviation 1.51 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 31 | 16.7 breaths per minute | Standard Deviation 1.15 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 61 | 18.0 breaths per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 10 | 16.6 breaths per minute | Standard Deviation 0.97 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 64 | 18.0 breaths per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 34 | 18.0 breaths per minute | Standard Deviation 0 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 19 | 16.8 breaths per minute | Standard Deviation 1.1 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 70 | 18.0 breaths per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 37 | 17.0 breaths per minute | Standard Deviation 1.41 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 7 | 16.9 breaths per minute | Standard Deviation 1.04 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 40 | 16.7 breaths per minute | Standard Deviation 1.15 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 79 | 18.0 breaths per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 22 | 16.8 breaths per minute | Standard Deviation 1.1 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 43 | 18.0 breaths per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 85 | 18.0 breaths per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 13 | 16.5 breaths per minute | Standard Deviation 0.93 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 46 | 18.0 breaths per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 91 | 17.0 breaths per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 25 | 16.7 breaths per minute | Standard Deviation 1.15 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 94 | 18.0 breaths per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 49 | 18.0 breaths per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 97 | 16.0 breaths per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 4 | 17.0 breaths per minute | Standard Deviation 1.24 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Week 100 | 18.0 breaths per minute | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Respiratory Rate | Baseline | 16.7 breaths per minute | Standard Deviation 0.99 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 82 | 16.0 breaths per minute | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 85 | 18.0 breaths per minute | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 88 | 16.0 breaths per minute | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 91 | 16.0 breaths per minute | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 94 | 16.0 breaths per minute | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 97 | 18.0 breaths per minute | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 100 | 16.0 breaths per minute | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Baseline | 16.7 breaths per minute | Standard Deviation 0.96 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 4 | 16.9 breaths per minute | Standard Deviation 1.23 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 7 | 16.6 breaths per minute | Standard Deviation 0.9 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 10 | 17.2 breaths per minute | Standard Deviation 1.69 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 13 | 16.0 breaths per minute | Standard Deviation 0 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 16 | 17.0 breaths per minute | Standard Deviation 2.24 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 19 | 15.3 breaths per minute | Standard Deviation 1.63 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 22 | 16.3 breaths per minute | Standard Deviation 0.82 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 25 | 16.0 breaths per minute | Standard Deviation 0 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 28 | 16.2 breaths per minute | Standard Deviation 0.45 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 31 | 16.0 breaths per minute | Standard Deviation 0 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 34 | 16.7 breaths per minute | Standard Deviation 1.15 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 37 | 15.3 breaths per minute | Standard Deviation 1.15 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 40 | 16.0 breaths per minute | Standard Deviation 0 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 43 | 17.0 breaths per minute | Standard Deviation 1.73 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 46 | 15.7 breaths per minute | Standard Deviation 0.58 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 49 | 15.7 breaths per minute | Standard Deviation 0.58 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 52 | 16.7 breaths per minute | Standard Deviation 1.15 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 55 | 16.0 breaths per minute | Standard Deviation 0 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 58 | 17.0 breaths per minute | Standard Deviation 1.41 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 61 | 16.0 breaths per minute | Standard Deviation 0 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 64 | 16.0 breaths per minute | Standard Deviation 0 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 67 | 16.5 breaths per minute | Standard Deviation 0.71 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 70 | 17.0 breaths per minute | Standard Deviation 1.41 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 73 | 17.0 breaths per minute | Standard Deviation 1.41 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 76 | 16.0 breaths per minute | Standard Deviation 0 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Respiratory Rate | Week 79 | 17.0 breaths per minute | Standard Deviation 1.41 |
Secondary
Vital Signs Results - System Blood Pressure
Vital signs results assessed throughout the study.
Time frame: Overall study up to 24 months
Population: The Full Analysis Set consists of all subjects taking any amount of trial vaccine
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 52 | 154.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 28 | 139.3 mmHg | Standard Deviation 35.8 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 55 | 149.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 16 | 133.5 mmHg | Standard Deviation 17.88 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 31 | 134.7 mmHg | Standard Deviation 6.66 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 61 | 150.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 10 | 130.0 mmHg | Standard Deviation 18.13 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 64 | 155.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 34 | 130.3 mmHg | Standard Deviation 8.74 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 19 | 141.2 mmHg | Standard Deviation 17.91 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 70 | 148.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 37 | 140.0 mmHg | Standard Deviation 1.41 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 7 | 135.1 mmHg | Standard Deviation 20.35 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 40 | 140.0 mmHg | Standard Deviation 20.42 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 79 | 142.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 22 | 139.2 mmHg | Standard Deviation 36.08 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 43 | 141.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 85 | 169.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 13 | 129.9 mmHg | Standard Deviation 12.19 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 46 | 177.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 91 | 142.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 25 | 146.0 mmHg | Standard Deviation 27.06 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 94 | 148.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 49 | 150.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 97 | 159.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 4 | 121.3 mmHg | Standard Deviation 16.43 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Week 100 | 165.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - System Blood Pressure | Baseline | 127.0 mmHg | Standard Deviation 18.72 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 82 | 118.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 85 | 134.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 88 | 116.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 91 | 135.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 94 | 136.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 97 | 125.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 100 | 120.0 mmHg | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Baseline | 129.9 mmHg | Standard Deviation 16.15 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 4 | 123.2 mmHg | Standard Deviation 13.29 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 7 | 125.9 mmHg | Standard Deviation 11.29 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 10 | 126.5 mmHg | Standard Deviation 11.75 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 13 | 129.7 mmHg | Standard Deviation 7.5 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 16 | 127.4 mmHg | Standard Deviation 10.16 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 19 | 113.7 mmHg | Standard Deviation 12.08 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 22 | 121.0 mmHg | Standard Deviation 11.49 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 25 | 129.4 mmHg | Standard Deviation 12.54 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 28 | 123.8 mmHg | Standard Deviation 11.69 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 31 | 118.7 mmHg | Standard Deviation 3.79 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 34 | 124.3 mmHg | Standard Deviation 4.51 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 37 | 138.0 mmHg | Standard Deviation 19.92 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 40 | 111.0 mmHg | Standard Deviation 15.87 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 43 | 129.3 mmHg | Standard Deviation 11.72 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 46 | 132.7 mmHg | Standard Deviation 3.79 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 49 | 127.7 mmHg | Standard Deviation 15.04 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 52 | 120.3 mmHg | Standard Deviation 17.79 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 55 | 139.0 mmHg | Standard Deviation 4.24 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 58 | 134.0 mmHg | Standard Deviation 2.83 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 61 | 132.0 mmHg | Standard Deviation 9.9 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 64 | 129.0 mmHg | Standard Deviation 1.41 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 67 | 143.0 mmHg | Standard Deviation 8.49 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 70 | 138.5 mmHg | Standard Deviation 10.61 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 73 | 140.0 mmHg | Standard Deviation 11.31 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 76 | 119.0 mmHg | Standard Deviation 26.87 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - System Blood Pressure | Week 79 | 125.0 mmHg | Standard Deviation 1.41 |
Secondary
Vital Signs Results - Temperature
Vital signs results assessed throughout the study.
Time frame: Overall study up to 24 months
Population: The Full Analysis Set consists of all subjects taking any amount of trial vaccine
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 25 | 36.61 Celsius | Standard Deviation 0.322 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 52 | 36.90 Celsius | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 13 | 36.57 Celsius | Standard Deviation 0.167 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 55 | 36.40 Celsius | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 28 | 36.67 Celsius | Standard Deviation 0.153 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 7 | 36.60 Celsius | Standard Deviation 0.196 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 61 | 36.60 Celsius | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 31 | 36.75 Celsius | Standard Deviation 0.33 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 64 | 36.70 Celsius | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 16 | 36.63 Celsius | Standard Deviation 0.191 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 34 | 36.71 Celsius | Standard Deviation 0.013 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 4 | 36.63 Celsius | Standard Deviation 0.218 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 37 | 36.84 Celsius | Standard Deviation 0.644 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 19 | 36.68 Celsius | Standard Deviation 0.217 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 79 | 37.10 Celsius | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 40 | 36.61 Celsius | Standard Deviation 0.379 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 10 | 36.61 Celsius | Standard Deviation 0.166 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 85 | 36.20 Celsius | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 43 | 36.80 Celsius | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 22 | 36.70 Celsius | Standard Deviation 0.316 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 91 | 36.40 Celsius | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 46 | 36.80 Celsius | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 94 | 36.60 Celsius | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Baseline | 36.58 Celsius | Standard Deviation 0.31 |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 97 | 36.70 Celsius | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 49 | 36.70 Celsius | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 100 | 36.90 Celsius | — |
| CV301 + Atezolizumab (Cohort 1) | Vital Signs Results - Temperature | Week 70 | 36.80 Celsius | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 82 | 36.70 Celsius | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 85 | 36.30 Celsius | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 88 | 36.60 Celsius | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 91 | 36.30 Celsius | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 94 | 36.10 Celsius | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 97 | 36.60 Celsius | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 100 | 36.60 Celsius | — |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Baseline | 36.64 Celsius | Standard Deviation 0.239 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 4 | 36.57 Celsius | Standard Deviation 0.232 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 7 | 36.66 Celsius | Standard Deviation 0.292 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 10 | 36.51 Celsius | Standard Deviation 0.241 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 13 | 36.53 Celsius | Standard Deviation 0.327 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 16 | 36.62 Celsius | Standard Deviation 0.213 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 19 | 36.45 Celsius | Standard Deviation 0.367 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 22 | 36.44 Celsius | Standard Deviation 0.382 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 25 | 36.62 Celsius | Standard Deviation 0.32 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 28 | 36.72 Celsius | Standard Deviation 0.416 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 31 | 36.56 Celsius | Standard Deviation 0.161 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 34 | 36.65 Celsius | Standard Deviation 0.274 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 37 | 36.70 Celsius | Standard Deviation 0.213 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 40 | 37.17 Celsius | Standard Deviation 0.409 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 43 | 36.86 Celsius | Standard Deviation 0.076 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 46 | 36.59 Celsius | Standard Deviation 0.103 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 49 | 36.79 Celsius | Standard Deviation 0.135 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 52 | 36.72 Celsius | Standard Deviation 0.434 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 55 | 36.53 Celsius | Standard Deviation 0.189 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 58 | 36.66 Celsius | Standard Deviation 0.063 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 61 | 36.53 Celsius | Standard Deviation 0.189 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 64 | 36.64 Celsius | Standard Deviation 0.196 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 67 | 36.60 Celsius | Standard Deviation 0.141 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 70 | 36.51 Celsius | Standard Deviation 0.149 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 73 | 36.35 Celsius | Standard Deviation 0.212 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 76 | 36.76 Celsius | Standard Deviation 0.204 |
| CV301 + Atezolizumab (Cohort 2) | Vital Signs Results - Temperature | Week 79 | 36.12 Celsius | Standard Deviation 0.456 |