Trial Outcomes & Findings for SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer (NCT NCT03066947)
NCT ID: NCT03066947
Last Updated: 2021-01-29
Results Overview
To evaluate the number of patients with toxicity events while on SV-BR-1-GM, as defined by the Common Terminology Criteria for Adverse Events (CTCAE)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Through study completion, an average of 1 year
Results posted on
2021-01-29
Participant Flow
Participant milestones
| Measure |
SV-BR-1-GM Monotherapy
Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites \~2 and \~4 days after SV-BR-1-GM inoculation
SV-BR-1-GM: See above
Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells
Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer
Baseline characteristics by cohort
| Measure |
SV-BR-1-GM Monotherapy
n=24 Participants
Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites \~2 and \~4 days after SV-BR-1-GM inoculation
SV-BR-1-GM: See above
Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells
Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: All patients
To evaluate the number of patients with toxicity events while on SV-BR-1-GM, as defined by the Common Terminology Criteria for Adverse Events (CTCAE)
Outcome measures
| Measure |
SV-BR-1-GM Monotherapy
n=24 Participants
Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites \~2 and \~4 days after SV-BR-1-GM inoculation
SV-BR-1-GM: See above
Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells
Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response
|
|---|---|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Patients with Adverse Events
|
24 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Erythema injection site
|
11 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Pruritis injection site
|
8 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Induration injection site
|
7 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Fatigue
|
6 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Nausea
|
6 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Constipation
|
5 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Abdominal pain
|
4 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Flu like symptoms
|
4 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Diarrhea
|
3 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
GGTP increased
|
3 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Injection site reaction
|
3 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Urinary Tract Infection
|
3 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Vomiting
|
3 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Abdominal distension
|
2 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Alkaline Phosphatase Increased
|
2 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
ALT Increased
|
2 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Anorexia
|
2 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
AST Increased
|
2 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Back Pain
|
2 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Chills
|
2 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Decreased appetite
|
2 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Dehydration
|
2 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Dizziness
|
2 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Erythema Multiforme
|
2 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Glucose increased
|
2 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Hematocrit Decreased
|
2 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Hypercalcemia
|
2 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Lymphocytes Decreased
|
2 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Myalgia
|
2 Participants
|
|
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Pleural Effusion
|
2 Participants
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearTo evaluate the duration of toxicity events while on SV-BR-1-GM, as defined by CTCAE
Outcome measures
| Measure |
SV-BR-1-GM Monotherapy
n=24 Participants
Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites \~2 and \~4 days after SV-BR-1-GM inoculation
SV-BR-1-GM: See above
Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells
Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response
|
|---|---|
|
Duration of Treatment Emergent Adverse Events [Safety]
|
8 Days
Interval 0.0 to 422.0
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: Number with related adverse events
To evaluate the number of participants with an adverse event related to SV-BR-1-GM administration, as defined by CTCAE
Outcome measures
| Measure |
SV-BR-1-GM Monotherapy
n=24 Participants
Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites \~2 and \~4 days after SV-BR-1-GM inoculation
SV-BR-1-GM: See above
Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells
Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response
|
|---|---|
|
Number of Participants With an Adverse Event Related to SV-BR-1-GM Administration [Safety]
|
23 Participants
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearObjective response rate (ORR), defined as complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors (RECIST) and immune-related RECIST (iRECIST) criteria.
Outcome measures
| Measure |
SV-BR-1-GM Monotherapy
n=24 Participants
Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites \~2 and \~4 days after SV-BR-1-GM inoculation
SV-BR-1-GM: See above
Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells
Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response
|
|---|---|
|
Objective Tumor Response Rate
|
0 Participants
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearNon-progressive rate, defined as CR, PR or stable disease (SD) per RECIST and iRECIST criteria
Outcome measures
| Measure |
SV-BR-1-GM Monotherapy
n=24 Participants
Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites \~2 and \~4 days after SV-BR-1-GM inoculation
SV-BR-1-GM: See above
Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells
Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response
|
|---|---|
|
Rate of Non-progression of Tumors
|
4 Participants
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearDurability of response, as defined as complete response (disappearance of all tumors), partial response (30% or greater reduction in the sum of diameters of target lesions (tumors) with stable disease in non-target lesions) or stable disease (less than 20% increase in the sum of diameters of target lesions with no new lesions appearing) by evaluating those patients eligible to complete the optional treatments from 9-12 months
Outcome measures
| Measure |
SV-BR-1-GM Monotherapy
n=24 Participants
Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites \~2 and \~4 days after SV-BR-1-GM inoculation
SV-BR-1-GM: See above
Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells
Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response
|
|---|---|
|
Durability of Tumor Response
|
105.5 days
Interval 79.0 to 197.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of 1 yearTo assess immune responses to SV-BR-1-GM, and to recall antigens, if any, as measured by DTH skin tests and/or other immunological tests
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of 1 yearTo measure the quality of life (QOL) of participants using the SF-36 Health Survey, which includes measures of General Health, Limitations of Activity, Physical Health Problems, Emotional Health Problems, Social Activities, Energy and Emotions.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of 1 yearTo measure changes in weight.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of 1 yearTo measure changes in performance status using the Eastern Cooperative Oncology Group (ECOG) scale
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of 1 yearTo measure changes in pain using a scale from None to Very Mild to Mild to Moderate to Severe to Very Severe
Outcome measures
Outcome data not reported
Adverse Events
SV-BR-1-GM Monotherapy
Serious events: 8 serious events
Other events: 24 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
SV-BR-1-GM Monotherapy
n=24 participants at risk
Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites \~2 and \~4 days after SV-BR-1-GM inoculation
SV-BR-1-GM: See above
Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells
Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
4.2%
1/24 • Number of events 1 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Cardiac disorders
Restrictive Cardiomyopathy
|
4.2%
1/24 • Number of events 1 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
1/24 • Number of events 1 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Infections and infestations
Sepsis
|
4.2%
1/24 • Number of events 1 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Infections and infestations
Urinary Tract Infection
|
4.2%
1/24 • Number of events 1 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Gastrointestinal disorders
GERD
|
4.2%
1/24 • Number of events 1 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Cardiac disorders
Palpitations
|
4.2%
1/24 • Number of events 1 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.2%
1/24 • Number of events 1 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
General disorders
Fever
|
4.2%
1/24 • Number of events 1 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
4.2%
1/24 • Number of events 1 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Infections and infestations
Influenza A
|
4.2%
1/24 • Number of events 1 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Metabolism and nutrition disorders
Worsening of Hypercalcemia
|
4.2%
1/24 • Number of events 1 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
Other adverse events
| Measure |
SV-BR-1-GM Monotherapy
n=24 participants at risk
Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites \~2 and \~4 days after SV-BR-1-GM inoculation
SV-BR-1-GM: See above
Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells
Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response
|
|---|---|
|
General disorders
Erythema, injection site
|
45.8%
11/24 • Number of events 42 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
General disorders
Pruritis, injection site
|
33.3%
8/24 • Number of events 14 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
General disorders
Induration, injection site
|
29.2%
7/24 • Number of events 31 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
General disorders
Fatigue
|
25.0%
6/24 • Number of events 8 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Gastrointestinal disorders
Nausea
|
25.0%
6/24 • Number of events 8 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Gastrointestinal disorders
Constipation
|
20.8%
5/24 • Number of events 5 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
4/24 • Number of events 5 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
General disorders
Flu like symptoms
|
16.7%
4/24 • Number of events 5 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
3/24 • Number of events 5 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Investigations
GGTP increased
|
12.5%
3/24 • Number of events 5 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
General disorders
Injection site reaction
|
12.5%
3/24 • Number of events 3 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Infections and infestations
Urinary Tract Infection
|
12.5%
3/24 • Number of events 3 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
3/24 • Number of events 3 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
2/24 • Number of events 2 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Investigations
Alkaline Phosphatase Increased
|
8.3%
2/24 • Number of events 4 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Investigations
ALT Increased
|
8.3%
2/24 • Number of events 2 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Metabolism and nutrition disorders
Anorexia
|
8.3%
2/24 • Number of events 2 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Investigations
AST Increased
|
8.3%
2/24 • Number of events 4 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.3%
2/24 • Number of events 2 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
General disorders
Chills
|
8.3%
2/24 • Number of events 2 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
2/24 • Number of events 2 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
2/24 • Number of events 2 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Nervous system disorders
Dizziness
|
8.3%
2/24 • Number of events 2 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
8.3%
2/24 • Number of events 2 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Investigations
Glucose increased
|
8.3%
2/24 • Number of events 2 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Investigations
Hematocrit Decreased
|
8.3%
2/24 • Number of events 2 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.3%
2/24 • Number of events 4 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Investigations
Lymphocytes Decreased
|
8.3%
2/24 • Number of events 2 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
2/24 • Number of events 2 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
8.3%
2/24 • Number of events 2 • up to 1 year
Used CTCAE V4.03 to determine adverse event intensity
|
Additional Information
Dr. William Williams
BriaCell Therapeutics Corporation
Phone: 1-888-485-6340
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place