Trial Outcomes & Findings for Vaccination of Triple Negative Breast Cancer Patients (NCT NCT02938442)
NCT ID: NCT02938442
Last Updated: 2024-11-07
Results Overview
A Safety/Tolerability Event is defined as the occurrence of one of the following: * A Serious Adverse Event, OR * A non-Serious Adverse Event of Grade = 3, 4, or 5, OR * A non-Serious Adverse Event of Grade = 2 whose Relationship to P10s-PADRE Vaccine was classified as Definite, Probable, or Possible
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
16 participants
Primary outcome timeframe
From the start of treatment to the time of definitive surgery (4-8 weeks after chemo); from Week 0 to Week 20-23
Results posted on
2024-11-07
Participant Flow
Participant milestones
| Measure |
Chemotherapy Only
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
11
|
|
Overall Study
COMPLETED
|
3
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Chemotherapy Only
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Vaccination of Triple Negative Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
Chemotherapy Only
n=5 Participants
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
n=11 Participants
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 9.91 • n=5 Participants
|
56.55 years
STANDARD_DEVIATION 11.26 • n=7 Participants
|
56.5 years
STANDARD_DEVIATION 10.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the start of treatment to the time of definitive surgery (4-8 weeks after chemo); from Week 0 to Week 20-23A Safety/Tolerability Event is defined as the occurrence of one of the following: * A Serious Adverse Event, OR * A non-Serious Adverse Event of Grade = 3, 4, or 5, OR * A non-Serious Adverse Event of Grade = 2 whose Relationship to P10s-PADRE Vaccine was classified as Definite, Probable, or Possible
Outcome measures
| Measure |
Chemotherapy Only
n=5 Participants
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
n=11 Participants
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
|---|---|---|
|
Safety and Tolerability Adverse Events
|
8 Total events
|
81 Total events
|
PRIMARY outcome
Timeframe: During and/or Immediately After SurgeryA tumor-response call of either ypT0N0 or ypTisN0 determined through surgical staging after neoadjuvant therapy. The staging system used to determine the tumor-response call is the AJCC Staging System described in a 2014 FDA Guidance for Industry. • A tumor-response call of "pyT0N0" is also equated with pCR in the published literature.
Outcome measures
| Measure |
Chemotherapy Only
n=5 Participants
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
n=11 Participants
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
|---|---|---|
|
Pathologic Complete Response (pCR)
Pathologic Complete Response (pCR)
|
1 Participants
|
2 Participants
|
|
Pathologic Complete Response (pCR)
No Pathologic Complete Response (pCR)
|
4 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: SurgeryPopulation: For 2 participants, there was no data.
Tumor size at surgery/pathology report
Outcome measures
| Measure |
Chemotherapy Only
n=5 Participants
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
n=9 Participants
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
|---|---|---|
|
Pathological Tumor Size
|
3.52 centimeters
Standard Deviation 5.65
|
0.98 centimeters
Standard Deviation 0.85
|
PRIMARY outcome
Timeframe: SurgeryPopulation: For 3 participants, there were no data.
Number of positive lymph nodes found out of dissected lymph nodes
Outcome measures
| Measure |
Chemotherapy Only
n=5 Participants
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
n=8 Participants
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
|---|---|---|
|
Pathological Node Status: Number of Positive Lymph Nodes
|
6.6 lymph node
Standard Deviation 14.76
|
1.5 lymph node
Standard Deviation 3.46
|
PRIMARY outcome
Timeframe: SurgeryPopulation: Chemotherapy Only and Chemo+Vaccine arms have different schedules of activities.
Number of dissected lymph nodes at surgery for study participants
Outcome measures
| Measure |
Chemotherapy Only
n=5 Participants
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
n=11 Participants
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
|---|---|---|
|
Pathological Node Status: Number of Dissected Lymph Nodes
|
10.2 lymph node
Standard Deviation 14.06
|
6.91 lymph node
Standard Deviation 5.74
|
PRIMARY outcome
Timeframe: SurgeryParticipants had their tumors surgically removed and pathologically staged using the AJCC Staging criteria. The main method of pathologic staging for breast cancer is the TNM system which stands for (Tumor size, lymph Node status and Metastases). "yp" prior to TN means the tissue was staged after neoadjuvant therapy. The larger the number after "T" means the larger the size, and the larger the number after "N" means the number of affected nearby lymph nodes. Therefore, tumor gradings with T3Nx are worse than those with T0Nx. The two categories "pyT0N0" and "ypT0N0" are both considered to be synonymous with pCR in the published literature.
Outcome measures
| Measure |
Chemotherapy Only
n=5 Participants
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
n=11 Participants
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
|---|---|---|
|
Tumor Response
mypT1aN
|
0 Participants
|
1 Participants
|
|
Tumor Response
mypT1ap
|
0 Participants
|
1 Participants
|
|
Tumor Response
mypT1b
|
0 Participants
|
1 Participants
|
|
Tumor Response
pyT0N0
|
0 Participants
|
1 Participants
|
|
Tumor Response
ypT0N0
|
1 Participants
|
1 Participants
|
|
Tumor Response
ypT0N3a
|
0 Participants
|
1 Participants
|
|
Tumor Response
ypT0pN1
|
0 Participants
|
1 Participants
|
|
Tumor Response
ypT1aN0
|
1 Participants
|
0 Participants
|
|
Tumor Response
ypT1cN0
|
1 Participants
|
0 Participants
|
|
Tumor Response
ypT1cN1
|
0 Participants
|
1 Participants
|
|
Tumor Response
ypT1cNX
|
0 Participants
|
1 Participants
|
|
Tumor Response
ypT1pN0
|
0 Participants
|
1 Participants
|
|
Tumor Response
ypT2N0
|
1 Participants
|
1 Participants
|
|
Tumor Response
ypT3Na
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Weeks 7, 10, 15, 18, 23, 46, and 70Population: Chemotherapy Only and Chemo+Vaccine arms have different schedules of activities.
The anti-P10s binding level was measured via ELISA method after incubation with a subject's serum samples. The endpoint titer was determined for each serum sample, and then fold change in endpoint titer in post-treatment weeks compared to pre-treatment week (Week 1) were calculated.
Outcome measures
| Measure |
Chemotherapy Only
n=5 Participants
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
n=11 Participants
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
|---|---|---|
|
Fold Increase in P10s-MAP-Reactive Immunoglobulin Titers
Week 7
|
1 fold change in serum titer
Standard Deviation 0
|
2.27 fold change in serum titer
Standard Deviation 2.83
|
|
Fold Increase in P10s-MAP-Reactive Immunoglobulin Titers
Week 10
|
—
|
3 fold change in serum titer
Standard Deviation 4.80
|
|
Fold Increase in P10s-MAP-Reactive Immunoglobulin Titers
Week 15
|
—
|
1.73 fold change in serum titer
Standard Deviation 2.1
|
|
Fold Increase in P10s-MAP-Reactive Immunoglobulin Titers
Week 18
|
—
|
1.36 fold change in serum titer
Standard Deviation 0.92
|
|
Fold Increase in P10s-MAP-Reactive Immunoglobulin Titers
Week 23
|
—
|
1.55 fold change in serum titer
Standard Deviation 1.21
|
|
Fold Increase in P10s-MAP-Reactive Immunoglobulin Titers
Week 46
|
1 fold change in serum titer
Standard Deviation 0
|
5.4 fold change in serum titer
Standard Deviation 9.45
|
|
Fold Increase in P10s-MAP-Reactive Immunoglobulin Titers
Week 70
|
—
|
6.25 fold change in serum titer
Standard Deviation 10.69
|
SECONDARY outcome
Timeframe: Week 1, 7, 10, 15, 18, 23, 46, 70Population: Chemotherapy Only and Chemo+Vaccine arms have different schedules of activities. For participants in Chemotherapy Only arm, Week 46, two participants either did not show up or were off study.
Using flow cytometry, the frequencies of NK cells were determined for samples collected from multiple timepoints from Week 1 to Week 70. Values were averaged for the percent of CD16+NK cells.
Outcome measures
| Measure |
Chemotherapy Only
n=5 Participants
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
n=11 Participants
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
|---|---|---|
|
Frequencies of NK Cells - CD16
Week 1
|
76.89 percentage of NK Cells
Standard Deviation 39.81
|
90.57 percentage of NK Cells
Standard Deviation 4.87
|
|
Frequencies of NK Cells - CD16
Week 7
|
66.72 percentage of NK Cells
Standard Deviation 32.41
|
87.36 percentage of NK Cells
Standard Deviation 5.84
|
|
Frequencies of NK Cells - CD16
Week 10
|
—
|
69.96 percentage of NK Cells
Standard Deviation 15.09
|
|
Frequencies of NK Cells - CD16
Week 15
|
—
|
83.38 percentage of NK Cells
Standard Deviation 7.82
|
|
Frequencies of NK Cells - CD16
Week 18
|
—
|
87.79 percentage of NK Cells
Standard Deviation 6.7
|
|
Frequencies of NK Cells - CD16
Week 23
|
—
|
80.9 percentage of NK Cells
Standard Deviation 5
|
|
Frequencies of NK Cells - CD16
Week 46
|
94.2 percentage of NK Cells
Standard Deviation 2.63
|
82.91 percentage of NK Cells
Standard Deviation 9.51
|
|
Frequencies of NK Cells - CD16
Week 70
|
—
|
96.64 percentage of NK Cells
Standard Deviation 6.92
|
SECONDARY outcome
Timeframe: Weeks 1, 7, 10, 15, 18, 23, 46, and 70Population: Chemotherapy Only and Chemo+Vaccine arms have different schedules of activities. For participants in Chemotherapy Only arm, Week 46, two participants either did not show up or were off study. For participants in Chemo+Vaccine arm, Week 46 and Week 70, participants either did not show up or were off study.
Using flow cytometry, the frequencies of NK cells were determined for samples collected from multiple timepoints from Week 1 to Week 70. Values were averaged for the percent of CD69+NK cells.
Outcome measures
| Measure |
Chemotherapy Only
n=5 Participants
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
n=11 Participants
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
|---|---|---|
|
Frequencies of NK Cells - CD69
Week 1
|
5.19 percentage of NK cells
Standard Deviation 2.06
|
7.89 percentage of NK cells
Standard Deviation 5.98
|
|
Frequencies of NK Cells - CD69
Week 7
|
3.64 percentage of NK cells
Standard Deviation 1.71
|
13.54 percentage of NK cells
Standard Deviation 5.28
|
|
Frequencies of NK Cells - CD69
week 10
|
—
|
5.98 percentage of NK cells
Standard Deviation 2.49
|
|
Frequencies of NK Cells - CD69
Week 15
|
—
|
15.73 percentage of NK cells
Standard Deviation 27.88
|
|
Frequencies of NK Cells - CD69
Week 18
|
—
|
9.52 percentage of NK cells
Standard Deviation 7.28
|
|
Frequencies of NK Cells - CD69
Week 23
|
—
|
11.21 percentage of NK cells
Standard Deviation 8.7
|
|
Frequencies of NK Cells - CD69
Week 46
|
2.93 percentage of NK cells
Standard Deviation 1.21
|
6.14 percentage of NK cells
Standard Deviation 3.35
|
|
Frequencies of NK Cells - CD69
Week 70
|
—
|
3.98 percentage of NK cells
Standard Deviation 1.97
|
SECONDARY outcome
Timeframe: Weeks 1, 7, 10, 15, 18, 23, 46, and 70Population: Chemotherapy Only and Chemo+Vaccine arms have different schedules of activities. For participants in Chemotherapy Only arm, Week 46, two participants either did not show up or were off study. For participants in Chemo+Vaccine arm, Weeks 1, 10, 25, 46 and 70, participants either did not show up or were off study.
Using flow cytometry, the frequencies of NK cells were determined for samples collected from multiple timepoints from Week 1 to Week 70. Values were averaged for the percent of NKp46+NK cells.
Outcome measures
| Measure |
Chemotherapy Only
n=5 Participants
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
n=11 Participants
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
|---|---|---|
|
Frequencies of NK Cells - NKp46
Week 1
|
87.98 percentage of NK cells
Standard Deviation 13.41
|
77.98 percentage of NK cells
Standard Deviation 29.16
|
|
Frequencies of NK Cells - NKp46
Week 7
|
73.64 percentage of NK cells
Standard Deviation 25.66
|
83.36 percentage of NK cells
Standard Deviation 16.84
|
|
Frequencies of NK Cells - NKp46
Week 10
|
—
|
70.35 percentage of NK cells
Standard Deviation 27.32
|
|
Frequencies of NK Cells - NKp46
Week 15
|
—
|
87.77 percentage of NK cells
Standard Deviation 11.01
|
|
Frequencies of NK Cells - NKp46
Week 18
|
—
|
90.15 percentage of NK cells
Standard Deviation 11.37
|
|
Frequencies of NK Cells - NKp46
Week 23
|
—
|
82.19 percentage of NK cells
Standard Deviation 28
|
|
Frequencies of NK Cells - NKp46
Week 46
|
77.13 percentage of NK cells
Standard Deviation 32.39
|
86.84 percentage of NK cells
Standard Deviation 10.25
|
|
Frequencies of NK Cells - NKp46
Week 70
|
—
|
90.31 percentage of NK cells
Standard Deviation 4.95
|
SECONDARY outcome
Timeframe: Weeks 1, 7, 10, 15, 18, 23, 46, and 70Population: Chemotherapy Only and Chemo+Vaccine arms have different schedules of activities. For participants in Chemotherapy Only arm, Week 46, two participants either did not show up or were off study. For participants in Chemo+Vaccine arm, Weeks 1, 46 and 70, participants either did not show up or were off study.
Using flow cytometry, the frequencies of NK cells were determined for samples collected from multiple timepoints from Week 1 to Week 70. Values were averaged for the percent of NKG2D+NK cells.
Outcome measures
| Measure |
Chemotherapy Only
n=5 Participants
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
n=11 Participants
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
|---|---|---|
|
Frequencies of NK Cells - NKG2D
Week 1
|
90.88 percentage of NK cells
Standard Deviation 6.67
|
93.74 percentage of NK cells
Standard Deviation 4.13
|
|
Frequencies of NK Cells - NKG2D
Week 7
|
81.76 percentage of NK cells
Standard Deviation 6.54
|
89.26 percentage of NK cells
Standard Deviation 6.24
|
|
Frequencies of NK Cells - NKG2D
Week 10
|
—
|
78.34 percentage of NK cells
Standard Deviation 15.83
|
|
Frequencies of NK Cells - NKG2D
Week 15
|
—
|
91.66 percentage of NK cells
Standard Deviation 6.93
|
|
Frequencies of NK Cells - NKG2D
Week 18
|
—
|
91.04 percentage of NK cells
Standard Deviation 4.94
|
|
Frequencies of NK Cells - NKG2D
Week 23
|
—
|
91.91 percentage of NK cells
Standard Deviation 6.48
|
|
Frequencies of NK Cells - NKG2D
Week 46
|
86.93 percentage of NK cells
Standard Deviation 8.56
|
89.33 percentage of NK cells
Standard Deviation 5.97
|
|
Frequencies of NK Cells - NKG2D
Week 70
|
—
|
91.46 percentage of NK cells
Standard Deviation 5.32
|
SECONDARY outcome
Timeframe: Weeks 1, 7, 10, 15, 18, 23, and 46Population: Chemotherapy Only and Chemo+Vaccine arms have different schedules of activities. For participants in Chemotherapy Only arm, Week 46, two participants either did not show up or were off study. For participants in Chemo+Vaccine arm, Weeks 1,7, and 23, participants either did not show up or were off study.
Using flow cytometry, the frequencies of CD3+/CD4+ T cells were determined for samples collected from multiple timepoints from Week 1 to Week 46. Values were averaged for the percent of CD4 T cells.
Outcome measures
| Measure |
Chemotherapy Only
n=5 Participants
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
n=11 Participants
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
|---|---|---|
|
Frequencies of T Cells - CD3+/CD4+
Week 1
|
58.9 percentage of T cell
Standard Deviation 16.38
|
54.64 percentage of T cell
Standard Deviation 11.64
|
|
Frequencies of T Cells - CD3+/CD4+
Week 7
|
45.92 percentage of T cell
Standard Deviation 18.34
|
59.89 percentage of T cell
Standard Deviation 10.91
|
|
Frequencies of T Cells - CD3+/CD4+
Week 10
|
—
|
46.59 percentage of T cell
Standard Deviation 12.37
|
|
Frequencies of T Cells - CD3+/CD4+
Week 15
|
—
|
47.38 percentage of T cell
Standard Deviation 11.60
|
|
Frequencies of T Cells - CD3+/CD4+
Week 18
|
—
|
48.57 percentage of T cell
Standard Deviation 10.19
|
|
Frequencies of T Cells - CD3+/CD4+
Week 23
|
—
|
43.97 percentage of T cell
Standard Deviation 14.07
|
|
Frequencies of T Cells - CD3+/CD4+
Week 46
|
39.83 percentage of T cell
Standard Deviation 5.1
|
43.66 percentage of T cell
Standard Deviation 13.72
|
SECONDARY outcome
Timeframe: Weeks 1, 7, 10, 15, 18, 23, and 46Population: Chemotherapy Only and Chemo+Vaccine arms have different schedules of activities. For participants in Chemotherapy Only arm, Week 46, two participants either did not show up or were off study. For participants in Chemo+Vaccine arm, Weeks 1, 7, 15, and 18, participants either did not show up or were off study.
Using flow cytometry, the frequencies of CD3+/CD8+ T cells were determined for samples collected from multiple timepoints from Week 1 to Week 46. Values were averaged for the percent of CD8 T cells.
Outcome measures
| Measure |
Chemotherapy Only
n=5 Participants
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
n=11 Participants
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
|---|---|---|
|
Frequencies of T Cells - CD3+/CD8+
Week 1
|
33.68 percentage of T cell
Standard Deviation 12.88
|
35.62 percentage of T cell
Standard Deviation 11.78
|
|
Frequencies of T Cells - CD3+/CD8+
Week 7
|
46.46 percentage of T cell
Standard Deviation 15.78
|
34.95 percentage of T cell
Standard Deviation 13.5
|
|
Frequencies of T Cells - CD3+/CD8+
Week 10
|
—
|
39.90 percentage of T cell
Standard Deviation 13.77
|
|
Frequencies of T Cells - CD3+/CD8+
Week 15
|
—
|
44.95 percentage of T cell
Standard Deviation 9.22
|
|
Frequencies of T Cells - CD3+/CD8+
Week 18
|
—
|
42.6 percentage of T cell
Standard Deviation 9.24
|
|
Frequencies of T Cells - CD3+/CD8+
Week 23
|
—
|
46.84 percentage of T cell
Standard Deviation 15.6
|
|
Frequencies of T Cells - CD3+/CD8+
Week 46
|
53.03 percentage of T cell
Standard Deviation 3.85
|
45.99 percentage of T cell
Standard Deviation 10.33
|
SECONDARY outcome
Timeframe: Weeks 1, 7, 10, 15, 18, 23, 46, and 70Population: Chemotherapy Only and Chemo+Vaccine arms have different schedules of activities. For participants in Chemotherapy Only arm, Week 46, two participants either did not show up or were off study. For participants in Chemo+Vaccine arm, Weeks 46 and 70, participants either did not show up or were off study.
Using flow cytometry, the frequencies of CD69+/CD3+ cells were determined for samples collected from multiple timepoints from Week 1 to Week 70. Values were averaged for the percent of CD69 T cells.
Outcome measures
| Measure |
Chemotherapy Only
n=5 Participants
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
n=11 Participants
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
|---|---|---|
|
Frequencies of Cells - CD69+/CD3+
Week 46
|
2.55 percentage of T cell
Standard Deviation 0.92
|
9 percentage of T cell
Standard Deviation 14.51
|
|
Frequencies of Cells - CD69+/CD3+
Week 1
|
3.17 percentage of T cell
Standard Deviation 2.21
|
4.57 percentage of T cell
Standard Deviation 2.55
|
|
Frequencies of Cells - CD69+/CD3+
Week 7
|
2.52 percentage of T cell
Standard Deviation 1.54
|
9.86 percentage of T cell
Standard Deviation 8.33
|
|
Frequencies of Cells - CD69+/CD3+
Week 10
|
—
|
4.61 percentage of T cell
Standard Deviation 2.87
|
|
Frequencies of Cells - CD69+/CD3+
Week 15
|
—
|
14.38 percentage of T cell
Standard Deviation 27.03
|
|
Frequencies of Cells - CD69+/CD3+
Week 18
|
—
|
8.17 percentage of T cell
Standard Deviation 6.23
|
|
Frequencies of Cells - CD69+/CD3+
Week 23
|
—
|
10.25 percentage of T cell
Standard Deviation 7.74
|
|
Frequencies of Cells - CD69+/CD3+
Week 70
|
—
|
4.02 percentage of T cell
Standard Deviation 2
|
SECONDARY outcome
Timeframe: Weeks 1, 7, 10, 15, 18, 23, 46, and 70Population: Chemotherapy Only and Chemo+Vaccine arms have different schedules of activities. For participants in Chemotherapy Only arm, Week 46, two participants either did not show up or were off study. For participants in Chemo+Vaccine arm, Weeks 1, 7, 10, 15, 46 and 70, participants either did not show up or were off study.
Peripheral blood mononuclear cells (PBMCs) were isolated from samples collected from multiple timepoints from Week 1 to Week 46. Using flow cytometry, the frequencies of Tregs (CD4, CD25 and CD127) were analyzed for separately, and then summed. The units are reported in CD4+CD25+CD127 low/- percentage because CD127 is a recently discovered antigen associated with Tregs that is weakly expressed on Tregs, while the self-activated memory T cell CD127 is strongly expressed; therefore, CD4+CD25+CD127 low/- is used to represent Tregs now.
Outcome measures
| Measure |
Chemotherapy Only
n=3 Participants
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
n=11 Participants
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
|---|---|---|
|
Frequencies of Circulating Regulatory T Cells (Tregs)
Week 1
|
9.68 percentage of Tcell CD4+CD25+CD127low/-
Standard Deviation 3.83
|
9.04 percentage of Tcell CD4+CD25+CD127low/-
Standard Deviation 3.37
|
|
Frequencies of Circulating Regulatory T Cells (Tregs)
Week 7
|
10.8 percentage of Tcell CD4+CD25+CD127low/-
Standard Deviation 4.59
|
5.27 percentage of Tcell CD4+CD25+CD127low/-
Standard Deviation 1.98
|
|
Frequencies of Circulating Regulatory T Cells (Tregs)
Week 10
|
—
|
8.26 percentage of Tcell CD4+CD25+CD127low/-
Standard Deviation 2.58
|
|
Frequencies of Circulating Regulatory T Cells (Tregs)
Week 15
|
—
|
8.82 percentage of Tcell CD4+CD25+CD127low/-
Standard Deviation 3.97
|
|
Frequencies of Circulating Regulatory T Cells (Tregs)
Week 23
|
—
|
5.75 percentage of Tcell CD4+CD25+CD127low/-
Standard Deviation 2.08
|
|
Frequencies of Circulating Regulatory T Cells (Tregs)
Week 46
|
8.48 percentage of Tcell CD4+CD25+CD127low/-
Standard Deviation 1.7
|
12.88 percentage of Tcell CD4+CD25+CD127low/-
Standard Deviation 6.25
|
|
Frequencies of Circulating Regulatory T Cells (Tregs)
Week 70
|
—
|
9.37 percentage of Tcell CD4+CD25+CD127low/-
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: Weeks 1, 7, 10, 15, 18, 23, 46, and 70Population: Chemotherapy Only and Chemo+Vaccine arms have different schedules of activities. For participants in Chemotherapy Only arm Week 46, two participants either did not show up or were off study. For participants in Chemo+Vaccine arm Week 46 one participant either did not show up or were off study, and Week 70 three participants either did not show up or were off study.
The expression levels of activation markers on NK cells profile, specifically CD16, were determined for samples collected from multiple timepoints from Week 1 to Week 70. Data is reported in the units Median Fluorescence Intensity (MFI).
Outcome measures
| Measure |
Chemotherapy Only
n=5 Participants
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
n=11 Participants
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
|---|---|---|
|
Activation Profiles of NK Cells: CD16
Week 1
|
72297.8 Median Fluorescence Intensity
Standard Deviation 21876.9
|
69622.91 Median Fluorescence Intensity
Standard Deviation 12067.19
|
|
Activation Profiles of NK Cells: CD16
Week 7
|
68472 Median Fluorescence Intensity
Standard Deviation 27775.62
|
72147.91 Median Fluorescence Intensity
Standard Deviation 13278.21
|
|
Activation Profiles of NK Cells: CD16
Week 10
|
—
|
50260 Median Fluorescence Intensity
Standard Deviation 20398.6
|
|
Activation Profiles of NK Cells: CD16
Week 15
|
—
|
56000.1 Median Fluorescence Intensity
Standard Deviation 19176
|
|
Activation Profiles of NK Cells: CD16
Week 18
|
—
|
62015.1 Median Fluorescence Intensity
Standard Deviation 16473.61
|
|
Activation Profiles of NK Cells: CD16
Week 23
|
—
|
66342.55 Median Fluorescence Intensity
Standard Deviation 19245.26
|
|
Activation Profiles of NK Cells: CD16
Week 46
|
68235 Median Fluorescence Intensity
Standard Deviation 6689.29
|
57106 Median Fluorescence Intensity
Standard Deviation 26203.70
|
|
Activation Profiles of NK Cells: CD16
Week 70
|
—
|
71401.13 Median Fluorescence Intensity
Standard Deviation 20553.46
|
SECONDARY outcome
Timeframe: Weeks 1, 7, 10, 15, 18, 23, 46, and 70Population: Chemotherapy Only and Chemo+Vaccine arms have different schedules of activities. For participants in Chemo+Vaccine arm Week 46 one participant either did not show up or were off study, and Week 70 three participants either did not show up or were off study.
The expression levels of activation markers on NK cells profile, specifically CD69, were determined for samples collected from multiple timepoints from Week 1 to Week 70. Data is reported in the units Median Fluorescence Intensity (MFI).
Outcome measures
| Measure |
Chemotherapy Only
n=5 Participants
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
n=11 Participants
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
|---|---|---|
|
Activation Profiles of NK Cells: CD69
Week 23
|
—
|
439.64 Median Fluorescence Intensity
Standard Deviation 62.75
|
|
Activation Profiles of NK Cells: CD69
Week 46
|
343 Median Fluorescence Intensity
Standard Deviation 11.5
|
413.4 Median Fluorescence Intensity
Standard Deviation 53.91
|
|
Activation Profiles of NK Cells: CD69
Week 1
|
374.2 Median Fluorescence Intensity
Standard Deviation 19.05
|
384.1 Median Fluorescence Intensity
Standard Deviation 52.52
|
|
Activation Profiles of NK Cells: CD69
Week 7
|
396.8 Median Fluorescence Intensity
Standard Deviation 62
|
445.55 Median Fluorescence Intensity
Standard Deviation 67.32
|
|
Activation Profiles of NK Cells: CD69
Week 10
|
—
|
423.64 Median Fluorescence Intensity
Standard Deviation 71.43
|
|
Activation Profiles of NK Cells: CD69
Week 15
|
—
|
418.73 Median Fluorescence Intensity
Standard Deviation 54.77
|
|
Activation Profiles of NK Cells: CD69
Week 18
|
—
|
419.82 Median Fluorescence Intensity
Standard Deviation 64.15
|
|
Activation Profiles of NK Cells: CD69
Week 70
|
—
|
389.63 Median Fluorescence Intensity
Standard Deviation 79.45
|
SECONDARY outcome
Timeframe: Weeks 1, 7, 10, 15, 18, 23, 46, and 70Population: Chemotherapy Only and Chemo+Vaccine arms have different schedules of activities. For participants in Chemo+Vaccine arm Week 46 one participant either did not show up or were off study, and Week 70 three participants either did not show up or were off study.
The expression levels of activation markers on NK cells profile, specifically NKp46, were determined for samples collected from multiple timepoints from Week 1 to Week 70. Data is reported in the units Median Fluorescence Intensity (MFI).
Outcome measures
| Measure |
Chemotherapy Only
n=5 Participants
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
n=11 Participants
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
|---|---|---|
|
Activation Profiles of NK Cells: NKp46
Week 18
|
—
|
2352.18 Median Fluorescence Intensity
Standard Deviation 932.15
|
|
Activation Profiles of NK Cells: NKp46
Week 23
|
—
|
1694.18 Median Fluorescence Intensity
Standard Deviation 754.75
|
|
Activation Profiles of NK Cells: NKp46
Week 46
|
940.67 Median Fluorescence Intensity
Standard Deviation 221.44
|
1785.4 Median Fluorescence Intensity
Standard Deviation 664.66
|
|
Activation Profiles of NK Cells: NKp46
Week 1
|
997.8 Median Fluorescence Intensity
Standard Deviation 97.72
|
1206.5 Median Fluorescence Intensity
Standard Deviation 451.05
|
|
Activation Profiles of NK Cells: NKp46
Week 7
|
1424.2 Median Fluorescence Intensity
Standard Deviation 592.34
|
1329.64 Median Fluorescence Intensity
Standard Deviation 578.46
|
|
Activation Profiles of NK Cells: NKp46
Week 10
|
—
|
2435.9 Median Fluorescence Intensity
Standard Deviation 1237.85
|
|
Activation Profiles of NK Cells: NKp46
Week 15
|
—
|
2600.82 Median Fluorescence Intensity
Standard Deviation 1161.2
|
|
Activation Profiles of NK Cells: NKp46
Week 70
|
—
|
1584.88 Median Fluorescence Intensity
Standard Deviation 452.15
|
SECONDARY outcome
Timeframe: Weeks 1, 7, 10, 15, 18, 23, 46, and 70Population: Chemotherapy Only and Chemo+Vaccine arms have different schedules of activities. For participants in Chemotherapy Only arm Week 46, two participants either did not show up or were off study. For participants in Chemo+Vaccine arm Week 46 one participant either did not show up or were off study, and Week 70 three participants either did not show up or were off study.
The expression levels of activation markers on NK cells profile, specifically NKG2D, were determined for samples collected from multiple timepoints from Week 1 to Week 70. Data is reported in the units Median Fluorescence Intensity (MFI).
Outcome measures
| Measure |
Chemotherapy Only
n=5 Participants
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
n=11 Participants
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
|---|---|---|
|
Activation Profiles of NK Cells: NKG2D
Week 1
|
900.2 Median Fluorescence Intensity
Standard Deviation 212.32
|
1050.6 Median Fluorescence Intensity
Standard Deviation 344.35
|
|
Activation Profiles of NK Cells: NKG2D
Week 7
|
776.2 Median Fluorescence Intensity
Standard Deviation 206.53
|
992.91 Median Fluorescence Intensity
Standard Deviation 388.52
|
|
Activation Profiles of NK Cells: NKG2D
Week 10
|
—
|
1059.18 Median Fluorescence Intensity
Standard Deviation 328.94
|
|
Activation Profiles of NK Cells: NKG2D
Week 15
|
—
|
1034.55 Median Fluorescence Intensity
Standard Deviation 365.92
|
|
Activation Profiles of NK Cells: NKG2D
Week 18
|
—
|
941.27 Median Fluorescence Intensity
Standard Deviation 346.34
|
|
Activation Profiles of NK Cells: NKG2D
Week 23
|
—
|
973.55 Median Fluorescence Intensity
Standard Deviation 283.06
|
|
Activation Profiles of NK Cells: NKG2D
Week 46
|
589 Median Fluorescence Intensity
Standard Deviation 159.6
|
738.6 Median Fluorescence Intensity
Standard Deviation 142.82
|
|
Activation Profiles of NK Cells: NKG2D
Week 70
|
—
|
795.38 Median Fluorescence Intensity
Standard Deviation 191.53
|
SECONDARY outcome
Timeframe: Weeks 1, 7, 10, 15, 18, 23, 46, 70Population: Chemotherapy Only and Chemo+Vaccine arms have different schedules of activities. For participants in Chemotherapy Only arm Week 46, two participants either did not show up or were off study. For participants in Chemo+Vaccine arm Week 46 one participant either did not show up or were off study, and Week 70 three participants either did not show up or were off study.
The expression levels of activation markers CD69 on T cells were determined by flow cytometry for samples collected from multiple timepoints from Week 1 to Week 70. Data is reported in the units Median Fluorescence Intensity (MFI).
Outcome measures
| Measure |
Chemotherapy Only
n=5 Participants
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
|
Chemo+Vaccine
n=11 Participants
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
|
|---|---|---|
|
Activation Profiles of T Cells - CD69 on CD3+
Week 1
|
368.8 Median Fluorescence Intensity (MFI)
Standard Deviation 31
|
394.55 Median Fluorescence Intensity (MFI)
Standard Deviation 64.34
|
|
Activation Profiles of T Cells - CD69 on CD3+
Week 7
|
403.2 Median Fluorescence Intensity (MFI)
Standard Deviation 62.35
|
411.27 Median Fluorescence Intensity (MFI)
Standard Deviation 63.6
|
|
Activation Profiles of T Cells - CD69 on CD3+
Week 10
|
—
|
436 Median Fluorescence Intensity (MFI)
Standard Deviation 86.79
|
|
Activation Profiles of T Cells - CD69 on CD3+
Week 15
|
—
|
412.27 Median Fluorescence Intensity (MFI)
Standard Deviation 154.74
|
|
Activation Profiles of T Cells - CD69 on CD3+
Week 18
|
—
|
401.09 Median Fluorescence Intensity (MFI)
Standard Deviation 102.43
|
|
Activation Profiles of T Cells - CD69 on CD3+
Week 23
|
—
|
396.73 Median Fluorescence Intensity (MFI)
Standard Deviation 54.14
|
|
Activation Profiles of T Cells - CD69 on CD3+
Week 46
|
382.33 Median Fluorescence Intensity (MFI)
Standard Deviation 68.12
|
388.8 Median Fluorescence Intensity (MFI)
Standard Deviation 92.09
|
|
Activation Profiles of T Cells - CD69 on CD3+
Week 70
|
—
|
333.38 Median Fluorescence Intensity (MFI)
Standard Deviation 34.1
|
Adverse Events
Control Arm
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Chemo+Vaccine Arm
Serious events: 4 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Control Arm
n=5 participants at risk
Control arm: SoC neoadjuvant chemotherapy starting week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin: Chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Cyclophosphamide: chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG three times. Vaccine administered on weeks 1, 2 and 3 prior to chemotherapy. Subject will start their SoC neoadjuvant chemotherapy on week 4 as described above.
Paclitaxel: chemo+vaccine arm immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4 as described above
|
Chemo+Vaccine Arm
n=11 participants at risk
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG three times. Vaccine administered on weeks 1, 2 and 3 prior to chemotherapy. Subjects will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG: Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1.
Doxorubicin: Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4.
Cyclophosphamide: Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4.
Paclitaxel: Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4.
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrilation
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
0.00%
0/11 • Week 1 to Week 70
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Vascular disorders
Vascular Disorders - Other, specify
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Infections and infestations
Infection and infestations, other, specify
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Psychiatric disorders
Confusion
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Investigations
Lymphocyte Count Decreased
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 2 • Week 1 to Week 70
|
Other adverse events
| Measure |
Control Arm
n=5 participants at risk
Control arm: SoC neoadjuvant chemotherapy starting week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Doxorubicin: Chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Cyclophosphamide: chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG three times. Vaccine administered on weeks 1, 2 and 3 prior to chemotherapy. Subject will start their SoC neoadjuvant chemotherapy on week 4 as described above.
Paclitaxel: chemo+vaccine arm immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4 as described above
|
Chemo+Vaccine Arm
n=11 participants at risk
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG three times. Vaccine administered on weeks 1, 2 and 3 prior to chemotherapy. Subjects will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
P10s-PADRE with MONTANIDE™ ISA 51 VG: Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1.
Doxorubicin: Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4.
Cyclophosphamide: Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4.
Paclitaxel: Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
5/5 • Number of events 18 • Week 1 to Week 70
|
100.0%
11/11 • Number of events 53 • Week 1 to Week 70
|
|
General disorders
Fatigue
|
100.0%
5/5 • Number of events 11 • Week 1 to Week 70
|
100.0%
11/11 • Number of events 47 • Week 1 to Week 70
|
|
Investigations
Lymphocyte count decreased
|
100.0%
5/5 • Number of events 24 • Week 1 to Week 70
|
100.0%
11/11 • Number of events 104 • Week 1 to Week 70
|
|
Investigations
Investigations, Other
|
100.0%
5/5 • Number of events 25 • Week 1 to Week 70
|
90.9%
10/11 • Number of events 60 • Week 1 to Week 70
|
|
Gastrointestinal disorders
Nausea
|
100.0%
5/5 • Number of events 12 • Week 1 to Week 70
|
81.8%
9/11 • Number of events 25 • Week 1 to Week 70
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
80.0%
4/5 • Number of events 5 • Week 1 to Week 70
|
90.9%
10/11 • Number of events 14 • Week 1 to Week 70
|
|
Investigations
White Blood Cells Decreased
|
80.0%
4/5 • Number of events 7 • Week 1 to Week 70
|
81.8%
9/11 • Number of events 36 • Week 1 to Week 70
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
5/5 • Number of events 8 • Week 1 to Week 70
|
63.6%
7/11 • Number of events 14 • Week 1 to Week 70
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous disorders, other
|
100.0%
5/5 • Number of events 9 • Week 1 to Week 70
|
63.6%
7/11 • Number of events 15 • Week 1 to Week 70
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
80.0%
4/5 • Number of events 6 • Week 1 to Week 70
|
63.6%
7/11 • Number of events 20 • Week 1 to Week 70
|
|
General disorders
Injection Site Reaction
|
0.00%
0/5 • Week 1 to Week 70
|
90.9%
10/11 • Number of events 21 • Week 1 to Week 70
|
|
Metabolism and nutrition disorders
Hyponatremia
|
60.0%
3/5 • Number of events 6 • Week 1 to Week 70
|
63.6%
7/11 • Number of events 19 • Week 1 to Week 70
|
|
Gastrointestinal disorders
Mucositis Oral
|
60.0%
3/5 • Number of events 6 • Week 1 to Week 70
|
63.6%
7/11 • Number of events 15 • Week 1 to Week 70
|
|
Gastrointestinal disorders
Constipation
|
60.0%
3/5 • Number of events 3 • Week 1 to Week 70
|
63.6%
7/11 • Number of events 13 • Week 1 to Week 70
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
60.0%
3/5 • Number of events 5 • Week 1 to Week 70
|
54.5%
6/11 • Number of events 14 • Week 1 to Week 70
|
|
Psychiatric disorders
Depression
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
72.7%
8/11 • Number of events 15 • Week 1 to Week 70
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Number of events 2 • Week 1 to Week 70
|
72.7%
8/11 • Number of events 13 • Week 1 to Week 70
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
40.0%
2/5 • Number of events 2 • Week 1 to Week 70
|
54.5%
6/11 • Number of events 7 • Week 1 to Week 70
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
60.0%
3/5 • Number of events 3 • Week 1 to Week 70
|
45.5%
5/11 • Number of events 6 • Week 1 to Week 70
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
1/5 • Number of events 2 • Week 1 to Week 70
|
63.6%
7/11 • Number of events 17 • Week 1 to Week 70
|
|
Nervous system disorders
Headache
|
60.0%
3/5 • Number of events 5 • Week 1 to Week 70
|
45.5%
5/11 • Number of events 12 • Week 1 to Week 70
|
|
Gastrointestinal disorders
Vomiting
|
60.0%
3/5 • Number of events 7 • Week 1 to Week 70
|
45.5%
5/11 • Number of events 11 • Week 1 to Week 70
|
|
Vascular disorders
Hypertension
|
80.0%
4/5 • Number of events 5 • Week 1 to Week 70
|
36.4%
4/11 • Number of events 8 • Week 1 to Week 70
|
|
Psychiatric disorders
Anxiety
|
40.0%
2/5 • Number of events 5 • Week 1 to Week 70
|
54.5%
6/11 • Number of events 8 • Week 1 to Week 70
|
|
Investigations
Alkaline Phosphatase Increased
|
60.0%
3/5 • Number of events 7 • Week 1 to Week 70
|
36.4%
4/11 • Number of events 7 • Week 1 to Week 70
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5 • Week 1 to Week 70
|
63.6%
7/11 • Number of events 13 • Week 1 to Week 70
|
|
General disorders
General disorders and administration site conditions - Other
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
54.5%
6/11 • Number of events 10 • Week 1 to Week 70
|
|
Investigations
Creatinine increased
|
20.0%
1/5 • Number of events 8 • Week 1 to Week 70
|
54.5%
6/11 • Number of events 14 • Week 1 to Week 70
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
54.5%
6/11 • Number of events 7 • Week 1 to Week 70
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
40.0%
2/5 • Number of events 3 • Week 1 to Week 70
|
45.5%
5/11 • Number of events 7 • Week 1 to Week 70
|
|
Reproductive system and breast disorders
Breast Pain
|
40.0%
2/5 • Number of events 2 • Week 1 to Week 70
|
45.5%
5/11 • Number of events 8 • Week 1 to Week 70
|
|
Gastrointestinal disorders
Gastrointestinal Disorders, Other
|
40.0%
2/5 • Number of events 3 • Week 1 to Week 70
|
45.5%
5/11 • Number of events 5 • Week 1 to Week 70
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
40.0%
2/5 • Number of events 2 • Week 1 to Week 70
|
45.5%
5/11 • Number of events 7 • Week 1 to Week 70
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
45.5%
5/11 • Number of events 9 • Week 1 to Week 70
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
2/5 • Number of events 3 • Week 1 to Week 70
|
36.4%
4/11 • Number of events 6 • Week 1 to Week 70
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
60.0%
3/5 • Number of events 4 • Week 1 to Week 70
|
27.3%
3/11 • Number of events 3 • Week 1 to Week 70
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
45.5%
5/11 • Number of events 11 • Week 1 to Week 70
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
40.0%
2/5 • Number of events 2 • Week 1 to Week 70
|
36.4%
4/11 • Number of events 7 • Week 1 to Week 70
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
40.0%
2/5 • Number of events 2 • Week 1 to Week 70
|
36.4%
4/11 • Number of events 7 • Week 1 to Week 70
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
45.5%
5/11 • Number of events 6 • Week 1 to Week 70
|
|
General disorders
Edema Limbs
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
45.5%
5/11 • Number of events 5 • Week 1 to Week 70
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
36.4%
4/11 • Number of events 5 • Week 1 to Week 70
|
|
General disorders
Pain
|
20.0%
1/5 • Number of events 3 • Week 1 to Week 70
|
36.4%
4/11 • Number of events 10 • Week 1 to Week 70
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
0.00%
0/5 • Week 1 to Week 70
|
45.5%
5/11 • Number of events 6 • Week 1 to Week 70
|
|
Vascular disorders
Hypotension
|
40.0%
2/5 • Number of events 2 • Week 1 to Week 70
|
27.3%
3/11 • Number of events 3 • Week 1 to Week 70
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
40.0%
2/5 • Number of events 2 • Week 1 to Week 70
|
27.3%
3/11 • Number of events 4 • Week 1 to Week 70
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/5 • Week 1 to Week 70
|
36.4%
4/11 • Number of events 4 • Week 1 to Week 70
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/5 • Week 1 to Week 70
|
36.4%
4/11 • Number of events 6 • Week 1 to Week 70
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
40.0%
2/5 • Number of events 2 • Week 1 to Week 70
|
18.2%
2/11 • Number of events 2 • Week 1 to Week 70
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
40.0%
2/5 • Number of events 4 • Week 1 to Week 70
|
18.2%
2/11 • Number of events 3 • Week 1 to Week 70
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • Week 1 to Week 70
|
36.4%
4/11 • Number of events 5 • Week 1 to Week 70
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
0.00%
0/5 • Week 1 to Week 70
|
36.4%
4/11 • Number of events 5 • Week 1 to Week 70
|
|
Ear and labyrinth disorders
Tinnitus
|
20.0%
1/5 • Number of events 2 • Week 1 to Week 70
|
27.3%
3/11 • Number of events 3 • Week 1 to Week 70
|
|
Eye disorders
Eye disorders - Other
|
0.00%
0/5 • Week 1 to Week 70
|
36.4%
4/11 • Number of events 6 • Week 1 to Week 70
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • Week 1 to Week 70
|
36.4%
4/11 • Number of events 13 • Week 1 to Week 70
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
27.3%
3/11 • Number of events 3 • Week 1 to Week 70
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
27.3%
3/11 • Number of events 4 • Week 1 to Week 70
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
27.3%
3/11 • Number of events 7 • Week 1 to Week 70
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/5 • Week 1 to Week 70
|
36.4%
4/11 • Number of events 7 • Week 1 to Week 70
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/5 • Week 1 to Week 70
|
27.3%
3/11 • Number of events 3 • Week 1 to Week 70
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
18.2%
2/11 • Number of events 3 • Week 1 to Week 70
|
|
Vascular disorders
Vascular disorder - other
|
20.0%
1/5 • Number of events 2 • Week 1 to Week 70
|
18.2%
2/11 • Number of events 2 • Week 1 to Week 70
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/5 • Week 1 to Week 70
|
27.3%
3/11 • Number of events 3 • Week 1 to Week 70
|
|
Infections and infestations
Infection and infestation - other
|
0.00%
0/5 • Week 1 to Week 70
|
27.3%
3/11 • Number of events 3 • Week 1 to Week 70
|
|
Nervous system disorders
Nervous system disorders - other
|
0.00%
0/5 • Week 1 to Week 70
|
27.3%
3/11 • Number of events 3 • Week 1 to Week 70
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
18.2%
2/11 • Number of events 6 • Week 1 to Week 70
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/5 • Week 1 to Week 70
|
27.3%
3/11 • Number of events 3 • Week 1 to Week 70
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/5 • Week 1 to Week 70
|
27.3%
3/11 • Number of events 3 • Week 1 to Week 70
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
40.0%
2/5 • Number of events 2 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/5 • Week 1 to Week 70
|
27.3%
3/11 • Number of events 4 • Week 1 to Week 70
|
|
Nervous system disorders
Dysgeusia
|
60.0%
3/5 • Number of events 3 • Week 1 to Week 70
|
0.00%
0/11 • Week 1 to Week 70
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
18.2%
2/11 • Number of events 2 • Week 1 to Week 70
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - other
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
18.2%
2/11 • Number of events 2 • Week 1 to Week 70
|
|
Gastrointestinal disorders
Abdominal Pain
|
20.0%
1/5 • Number of events 2 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 3 • Week 1 to Week 70
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • Week 1 to Week 70
|
18.2%
2/11 • Number of events 2 • Week 1 to Week 70
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/5 • Week 1 to Week 70
|
18.2%
2/11 • Number of events 2 • Week 1 to Week 70
|
|
Investigations
Cholesterol high
|
0.00%
0/5 • Week 1 to Week 70
|
18.2%
2/11 • Number of events 2 • Week 1 to Week 70
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/5 • Week 1 to Week 70
|
18.2%
2/11 • Number of events 2 • Week 1 to Week 70
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/5 • Week 1 to Week 70
|
18.2%
2/11 • Number of events 2 • Week 1 to Week 70
|
|
General disorders
Localized edema
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Metabolism and nutrition disorders
Obesity
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - other
|
40.0%
2/5 • Number of events 2 • Week 1 to Week 70
|
0.00%
0/11 • Week 1 to Week 70
|
|
Eye disorders
Blurred vision
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 2 • Week 1 to Week 70
|
|
Gastrointestinal disorders
Dyspepsia
|
40.0%
2/5 • Number of events 4 • Week 1 to Week 70
|
0.00%
0/11 • Week 1 to Week 70
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Nervous system disorders
Tremor
|
0.00%
0/5 • Week 1 to Week 70
|
18.2%
2/11 • Number of events 2 • Week 1 to Week 70
|
|
Infections and infestations
Sinusitis
|
0.00%
0/5 • Week 1 to Week 70
|
18.2%
2/11 • Number of events 2 • Week 1 to Week 70
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/5 • Week 1 to Week 70
|
18.2%
2/11 • Number of events 3 • Week 1 to Week 70
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/5 • Week 1 to Week 70
|
18.2%
2/11 • Number of events 3 • Week 1 to Week 70
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/5 • Week 1 to Week 70
|
18.2%
2/11 • Number of events 2 • Week 1 to Week 70
|
|
Nervous system disorders
Presyncope
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Cardiac disorders
Cardiac Disorders - other
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 2 • Week 1 to Week 70
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - other
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Investigations
Hemoglobin increased
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Investigations
Weight gain
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 5 • Week 1 to Week 70
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 2 • Week 1 to Week 70
|
|
Investigations
GGT increased
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 3 • Week 1 to Week 70
|
|
Investigations
INR increased
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 3 • Week 1 to Week 70
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 2 • Week 1 to Week 70
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 2 • Week 1 to Week 70
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Cardiac disorders
Atrial fibrillation
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
0.00%
0/11 • Week 1 to Week 70
|
|
Cardiac disorders
Heart failure
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
0.00%
0/11 • Week 1 to Week 70
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Nervous system disorders
Movements involuntary
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 3 • Week 1 to Week 70
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 2 • Week 1 to Week 70
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
0.00%
0/11 • Week 1 to Week 70
|
|
Infections and infestations
Paronychia
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
0.00%
0/11 • Week 1 to Week 70
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
0.00%
0/11 • Week 1 to Week 70
|
|
Vascular disorders
Lymphedema
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
0.00%
0/11 • Week 1 to Week 70
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Infections and infestations
Otitis Externa
|
20.0%
1/5 • Number of events 2 • Week 1 to Week 70
|
0.00%
0/11 • Week 1 to Week 70
|
|
Investigations
Lymphocyte count increased
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
0.00%
0/11 • Week 1 to Week 70
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 2 • Week 1 to Week 70
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 2 • Week 1 to Week 70
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 2 • Week 1 to Week 70
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 2 • Week 1 to Week 70
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Social circumstances
Social circumstances - other
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 2 • Week 1 to Week 70
|
|
Psychiatric disorders
Agitation
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Vascular disorders
Hematoma
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Cardiac disorders
Supraventricular tachycardia
|
20.0%
1/5 • Number of events 2 • Week 1 to Week 70
|
0.00%
0/11 • Week 1 to Week 70
|
|
Eye disorders
Optic nerve disorder
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
0.00%
0/11 • Week 1 to Week 70
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
0.00%
0/11 • Week 1 to Week 70
|
|
Infections and infestations
Enterocolitis infectious
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
0.00%
0/11 • Week 1 to Week 70
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
0.00%
0/11 • Week 1 to Week 70
|
|
Vascular disorders
Flushing
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
0.00%
0/11 • Week 1 to Week 70
|
|
Eye disorders
Glaucoma
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Immune system disorders
Immune system disorders - Other
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Renal and urinary disorders
Urinary retention
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
0.00%
0/11 • Week 1 to Week 70
|
|
Vascular disorders
Hot flashes
|
20.0%
1/5 • Number of events 1 • Week 1 to Week 70
|
0.00%
0/11 • Week 1 to Week 70
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/5 • Week 1 to Week 70
|
9.1%
1/11 • Number of events 1 • Week 1 to Week 70
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place