Breast Neoplasms, Triple Negative Breast Cancer
Conditions
Keywords
clinical stage I, II or III, TNBC, ER positive, PR positive, HER2 positive
Brief summary
The purpose of this study is to evaluate a new investigational cancer vaccine, P10s-PADRE in combination with standard neoadjuvant chemotherapy and surgery in patients with clinical stage I, II or III triple negative breast cancer (TNBC). This study will compare the vaccine plus standard neoadjuvant chemotherapy and surgery to standard neoadjuvant chemotherapy and surgery alone.
Detailed description
The purpose of this study is to evaluate an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with standard neoadjuvant chemotherapy in patients with clinical stage I, II or III estrogen-receptor (ER) negative, progesterone receptor (PR) negative and HER2-negative (= triple negative - TN) breast cancer. P10s-PADRE will be administered with MONTANIDE™ ISA 51 VG as adjuvant. Human breast cancers that express Tumor Associated Carbohydrate Antigens (TACAs) can be immunogenic, and enhancing the anti-TACA antibodies and immune effector function already present may augment the cytotoxic effects of standard therapies. A randomized two-arm, open-label, multi-center phase I/II trial is designed with the goal being to evaluate the efficacy of combining vaccination of the P10s-PADRE formulation with neoadjuvant chemotherapy. Patients will be randomly assigned in a 2:1 ratio to standard chemotherapy plus P10s-PADRE or to standard chemotherapy alone. Efficacy will be based on the rate of pathologic Complete Response (pCR) observed among TN breast-cancer patients treated with the combination as compared with the group of patients who receive standard chemotherapy alone.
Interventions
BIOLOGICALP10s-PADRE with MONTANIDE™ ISA 51 VG
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.
DRUGDoxorubicin
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.
DRUGCyclophosphamide
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.
DRUGPaclitaxel
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.
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Females of all races with biopsy-proven clinical stage I, II, or III TNBC (ER-negative, PR-negative and HER2-negative) who will undergo SoC neoadjuvant treatment * Age 18 years and older * ECOG Performance Status 0 or 1 * White blood cell (WBC) count ≥ 3,000/mm3 within 3 weeks prior to registration * Platelet count ≥ 100,000/mm3 within 3 weeks prior to registration * Bilirubin ≤ 2 x institutional upper limit (IUL) of normal obtained within 3 weeks prior to registration * Serum glutamic-oxaloacetic transaminase (SGOT) or aspartate aminotransferase test (AST) ≤ 2 x IUL of normal obtained within 3 weeks prior to registration * Serum glutamic-pyruvic transaminase (SGPT) or alanine aminotransferase test (ALT) ≤ 2 x IUL of normal obtained within 3 weeks prior to registration * Serum creatinine ≤ 1.8 mg/dl obtained within 3 weeks prior to registration * Must sign an informed consent document approved by the UAMS IRB
Exclusion criteria
* ER-positive, PR-positive, HER2-positive, inflammatory, metastatic, stage IV or recurrent breast cancer. * Active infection requiring treatment with antibiotics. * Existing diagnosis or history of organic brain syndrome that might preclude participation in the full protocol. * Existing diagnosis or history of significant impairment of basal cognitive function that might preclude participation in the full protocol. * Other current malignancies. Subjects with prior history at any time of any in situ cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration. Subjects with other malignancies are eligible if they have been continuously disease free for ≥ 5 years prior to the time of registration. * Active autoimmune disorders or conditions of immunosuppression; Existing diagnosis or history of autoimmune disorders or conditions of immunosuppression that have been in remission for less than 6 months. * Treatment with corticosteroids, including oral steroids (i.e. prednisone, dexamethasone \[except when used as an antiemetic in SoC therapy\]), continuous use of topical steroid creams or ointments or any steroid-containing inhalers. Subjects who discontinue the use of these classes of medication for at least 6 weeks prior to registration are eligible if, in the judgment of the treating physician, the subject is not likely to require these classes of drugs during the treatment period. Replacement doses of steroids for subjects with adrenal insufficiency are allowed. * Pregnancy or breastfeeding (due to the unknown effects of peptide/mimotope vaccines on a fetus or infant). Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to starting week 1 and must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 18 months after completing or discontinuing treatment. Accepted methods of contraception include oral contraceptives, barrier methods, IUDs, and abstinence. * Any other significant medical or psychiatric conditions, which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen. * Enrollment in any other clinical trial using investigational drug products or devices prior to first post-surgery study lab (Week 46 visit). Concurrent enrollment in observational studies is allowed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability Adverse Events | From the start of treatment to the time of definitive surgery (4-8 weeks after chemo); from Week 0 to Week 20-23 | 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 |
| Pathologic Complete Response (pCR) | During and/or Immediately After Surgery | A 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. |
| Pathological Tumor Size | Surgery | Tumor size at surgery/pathology report |
| Pathological Node Status: Number of Positive Lymph Nodes | Surgery | Number of positive lymph nodes found out of dissected lymph nodes |
| Pathological Node Status: Number of Dissected Lymph Nodes | Surgery | Number of dissected lymph nodes at surgery for study participants |
| Tumor Response | Surgery | Participants 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequencies of T Cells - CD3+/CD8+ | Weeks 1, 7, 10, 15, 18, 23, and 46 | 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. |
| Frequencies of Cells - CD69+/CD3+ | Weeks 1, 7, 10, 15, 18, 23, 46, and 70 | 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. |
| Frequencies of Circulating Regulatory T Cells (Tregs) | Weeks 1, 7, 10, 15, 18, 23, 46, and 70 | 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. |
| Activation Profiles of NK Cells: CD16 | Weeks 1, 7, 10, 15, 18, 23, 46, and 70 | 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). |
| Frequencies of NK Cells - NKG2D | Weeks 1, 7, 10, 15, 18, 23, 46, and 70 | 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. |
| Activation Profiles of NK Cells: NKp46 | Weeks 1, 7, 10, 15, 18, 23, 46, and 70 | 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). |
| Activation Profiles of NK Cells: NKG2D | Weeks 1, 7, 10, 15, 18, 23, 46, and 70 | 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). |
| Activation Profiles of T Cells - CD69 on CD3+ | Weeks 1, 7, 10, 15, 18, 23, 46, 70 | 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). |
| Activation Profiles of NK Cells: CD69 | Weeks 1, 7, 10, 15, 18, 23, 46, and 70 | 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). |
| Fold Increase in P10s-MAP-Reactive Immunoglobulin Titers | Weeks 7, 10, 15, 18, 23, 46, and 70 | 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. |
| Frequencies of NK Cells - CD16 | Week 1, 7, 10, 15, 18, 23, 46, 70 | 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. |
| Frequencies of NK Cells - CD69 | Weeks 1, 7, 10, 15, 18, 23, 46, and 70 | 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. |
| Frequencies of NK Cells - NKp46 | Weeks 1, 7, 10, 15, 18, 23, 46, and 70 | 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. |
| Frequencies of T Cells - CD3+/CD4+ | Weeks 1, 7, 10, 15, 18, 23, and 46 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 5 |
| 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. | 11 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | Chemotherapy Only | Chemo+Vaccine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 8 Participants | 12 Participants |
| Age, Continuous | 56.4 years STANDARD_DEVIATION 9.91 | 56.55 years STANDARD_DEVIATION 11.26 | 56.5 years STANDARD_DEVIATION 10.53 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 11 Participants | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 6 Participants | 10 Participants |
| Region of Enrollment United States | 5 Participants | 11 Participants | 16 Participants |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 16 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 1 / 11 |
| other Total, other adverse events | 5 / 5 | 11 / 11 |
| serious Total, serious adverse events | 1 / 5 | 4 / 11 |
Outcome results
Primary
Pathological Node Status: Number of Dissected Lymph Nodes
Number of dissected lymph nodes at surgery for study participants
Time frame: Surgery
Population: Chemotherapy Only and Chemo+Vaccine arms have different schedules of activities.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chemotherapy Only | Pathological Node Status: Number of Dissected Lymph Nodes | 10.2 lymph node | Standard Deviation 14.06 |
| Chemo+Vaccine | Pathological Node Status: Number of Dissected Lymph Nodes | 6.91 lymph node | Standard Deviation 5.74 |
Primary
Pathological Node Status: Number of Positive Lymph Nodes
Number of positive lymph nodes found out of dissected lymph nodes
Time frame: Surgery
Population: For 3 participants, there were no data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chemotherapy Only | Pathological Node Status: Number of Positive Lymph Nodes | 6.6 lymph node | Standard Deviation 14.76 |
| Chemo+Vaccine | Pathological Node Status: Number of Positive Lymph Nodes | 1.5 lymph node | Standard Deviation 3.46 |
Primary
Pathological Tumor Size
Tumor size at surgery/pathology report
Time frame: Surgery
Population: For 2 participants, there was no data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chemotherapy Only | Pathological Tumor Size | 3.52 centimeters | Standard Deviation 5.65 |
| Chemo+Vaccine | Pathological Tumor Size | 0.98 centimeters | Standard Deviation 0.85 |
Primary
Pathologic Complete Response (pCR)
A 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.
Time frame: During and/or Immediately After Surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chemotherapy Only | Pathologic Complete Response (pCR) | Pathologic Complete Response (pCR) | 1 Participants |
| Chemotherapy Only | Pathologic Complete Response (pCR) | No Pathologic Complete Response (pCR) | 4 Participants |
| Chemo+Vaccine | Pathologic Complete Response (pCR) | Pathologic Complete Response (pCR) | 2 Participants |
| Chemo+Vaccine | Pathologic Complete Response (pCR) | No Pathologic Complete Response (pCR) | 9 Participants |
Primary
Safety and Tolerability Adverse Events
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
Time frame: From the start of treatment to the time of definitive surgery (4-8 weeks after chemo); from Week 0 to Week 20-23
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chemotherapy Only | Safety and Tolerability Adverse Events | 8 Total events |
| Chemo+Vaccine | Safety and Tolerability Adverse Events | 81 Total events |
Primary
Tumor Response
Participants 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.
Time frame: Surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chemotherapy Only | Tumor Response | mypT1aN | 0 Participants |
| Chemotherapy Only | Tumor Response | mypT1ap | 0 Participants |
| Chemotherapy Only | Tumor Response | mypT1b | 0 Participants |
| Chemotherapy Only | Tumor Response | pyT0N0 | 0 Participants |
| Chemotherapy Only | Tumor Response | ypT0N0 | 1 Participants |
| Chemotherapy Only | Tumor Response | ypT0N3a | 0 Participants |
| Chemotherapy Only | Tumor Response | ypT0pN1 | 0 Participants |
| Chemotherapy Only | Tumor Response | ypT1aN0 | 1 Participants |
| Chemotherapy Only | Tumor Response | ypT1cN0 | 1 Participants |
| Chemotherapy Only | Tumor Response | ypT1cN1 | 0 Participants |
| Chemotherapy Only | Tumor Response | ypT1cNX | 0 Participants |
| Chemotherapy Only | Tumor Response | ypT1pN0 | 0 Participants |
| Chemotherapy Only | Tumor Response | ypT2N0 | 1 Participants |
| Chemotherapy Only | Tumor Response | ypT3Na | 1 Participants |
| Chemo+Vaccine | Tumor Response | ypT1cNX | 1 Participants |
| Chemo+Vaccine | Tumor Response | mypT1aN | 1 Participants |
| Chemo+Vaccine | Tumor Response | ypT1aN0 | 0 Participants |
| Chemo+Vaccine | Tumor Response | mypT1ap | 1 Participants |
| Chemo+Vaccine | Tumor Response | ypT2N0 | 1 Participants |
| Chemo+Vaccine | Tumor Response | mypT1b | 1 Participants |
| Chemo+Vaccine | Tumor Response | ypT1cN0 | 0 Participants |
| Chemo+Vaccine | Tumor Response | pyT0N0 | 1 Participants |
| Chemo+Vaccine | Tumor Response | ypT1pN0 | 1 Participants |
| Chemo+Vaccine | Tumor Response | ypT0N0 | 1 Participants |
| Chemo+Vaccine | Tumor Response | ypT1cN1 | 1 Participants |
| Chemo+Vaccine | Tumor Response | ypT0N3a | 1 Participants |
| Chemo+Vaccine | Tumor Response | ypT3Na | 0 Participants |
| Chemo+Vaccine | Tumor Response | ypT0pN1 | 1 Participants |
Secondary
Activation Profiles of NK Cells: CD16
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).
Time frame: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy Only | Activation Profiles of NK Cells: CD16 | Week 46 | 68235 Median Fluorescence Intensity | Standard Deviation 6689.29 |
| Chemotherapy Only | Activation Profiles of NK Cells: CD16 | Week 7 | 68472 Median Fluorescence Intensity | Standard Deviation 27775.62 |
| Chemotherapy Only | Activation Profiles of NK Cells: CD16 | Week 1 | 72297.8 Median Fluorescence Intensity | Standard Deviation 21876.9 |
| Chemo+Vaccine | Activation Profiles of NK Cells: CD16 | Week 10 | 50260 Median Fluorescence Intensity | Standard Deviation 20398.6 |
| Chemo+Vaccine | Activation Profiles of NK Cells: CD16 | Week 15 | 56000.1 Median Fluorescence Intensity | Standard Deviation 19176 |
| Chemo+Vaccine | Activation Profiles of NK Cells: CD16 | Week 18 | 62015.1 Median Fluorescence Intensity | Standard Deviation 16473.61 |
| Chemo+Vaccine | Activation Profiles of NK Cells: CD16 | Week 23 | 66342.55 Median Fluorescence Intensity | Standard Deviation 19245.26 |
| Chemo+Vaccine | Activation Profiles of NK Cells: CD16 | Week 46 | 57106 Median Fluorescence Intensity | Standard Deviation 26203.7 |
| Chemo+Vaccine | Activation Profiles of NK Cells: CD16 | Week 70 | 71401.13 Median Fluorescence Intensity | Standard Deviation 20553.46 |
| Chemo+Vaccine | Activation Profiles of NK Cells: CD16 | Week 1 | 69622.91 Median Fluorescence Intensity | Standard Deviation 12067.19 |
| Chemo+Vaccine | Activation Profiles of NK Cells: CD16 | Week 7 | 72147.91 Median Fluorescence Intensity | Standard Deviation 13278.21 |
Secondary
Activation Profiles of NK Cells: CD69
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).
Time frame: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy Only | Activation Profiles of NK Cells: CD69 | Week 46 | 343 Median Fluorescence Intensity | Standard Deviation 11.5 |
| Chemotherapy Only | Activation Profiles of NK Cells: CD69 | Week 7 | 396.8 Median Fluorescence Intensity | Standard Deviation 62 |
| Chemotherapy Only | Activation Profiles of NK Cells: CD69 | Week 1 | 374.2 Median Fluorescence Intensity | Standard Deviation 19.05 |
| Chemo+Vaccine | Activation Profiles of NK Cells: CD69 | Week 10 | 423.64 Median Fluorescence Intensity | Standard Deviation 71.43 |
| Chemo+Vaccine | Activation Profiles of NK Cells: CD69 | Week 15 | 418.73 Median Fluorescence Intensity | Standard Deviation 54.77 |
| Chemo+Vaccine | Activation Profiles of NK Cells: CD69 | Week 18 | 419.82 Median Fluorescence Intensity | Standard Deviation 64.15 |
| Chemo+Vaccine | Activation Profiles of NK Cells: CD69 | Week 23 | 439.64 Median Fluorescence Intensity | Standard Deviation 62.75 |
| Chemo+Vaccine | Activation Profiles of NK Cells: CD69 | Week 46 | 413.4 Median Fluorescence Intensity | Standard Deviation 53.91 |
| Chemo+Vaccine | Activation Profiles of NK Cells: CD69 | Week 70 | 389.63 Median Fluorescence Intensity | Standard Deviation 79.45 |
| Chemo+Vaccine | Activation Profiles of NK Cells: CD69 | Week 1 | 384.1 Median Fluorescence Intensity | Standard Deviation 52.52 |
| Chemo+Vaccine | Activation Profiles of NK Cells: CD69 | Week 7 | 445.55 Median Fluorescence Intensity | Standard Deviation 67.32 |
Secondary
Activation Profiles of NK Cells: NKG2D
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).
Time frame: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy Only | Activation Profiles of NK Cells: NKG2D | Week 46 | 589 Median Fluorescence Intensity | Standard Deviation 159.6 |
| Chemotherapy Only | Activation Profiles of NK Cells: NKG2D | Week 7 | 776.2 Median Fluorescence Intensity | Standard Deviation 206.53 |
| Chemotherapy Only | Activation Profiles of NK Cells: NKG2D | Week 1 | 900.2 Median Fluorescence Intensity | Standard Deviation 212.32 |
| Chemo+Vaccine | Activation Profiles of NK Cells: NKG2D | Week 10 | 1059.18 Median Fluorescence Intensity | Standard Deviation 328.94 |
| Chemo+Vaccine | Activation Profiles of NK Cells: NKG2D | Week 15 | 1034.55 Median Fluorescence Intensity | Standard Deviation 365.92 |
| Chemo+Vaccine | Activation Profiles of NK Cells: NKG2D | Week 18 | 941.27 Median Fluorescence Intensity | Standard Deviation 346.34 |
| Chemo+Vaccine | Activation Profiles of NK Cells: NKG2D | Week 23 | 973.55 Median Fluorescence Intensity | Standard Deviation 283.06 |
| Chemo+Vaccine | Activation Profiles of NK Cells: NKG2D | Week 46 | 738.6 Median Fluorescence Intensity | Standard Deviation 142.82 |
| Chemo+Vaccine | Activation Profiles of NK Cells: NKG2D | Week 70 | 795.38 Median Fluorescence Intensity | Standard Deviation 191.53 |
| Chemo+Vaccine | Activation Profiles of NK Cells: NKG2D | Week 1 | 1050.6 Median Fluorescence Intensity | Standard Deviation 344.35 |
| Chemo+Vaccine | Activation Profiles of NK Cells: NKG2D | Week 7 | 992.91 Median Fluorescence Intensity | Standard Deviation 388.52 |
Secondary
Activation Profiles of NK Cells: NKp46
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).
Time frame: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy Only | Activation Profiles of NK Cells: NKp46 | Week 46 | 940.67 Median Fluorescence Intensity | Standard Deviation 221.44 |
| Chemotherapy Only | Activation Profiles of NK Cells: NKp46 | Week 7 | 1424.2 Median Fluorescence Intensity | Standard Deviation 592.34 |
| Chemotherapy Only | Activation Profiles of NK Cells: NKp46 | Week 1 | 997.8 Median Fluorescence Intensity | Standard Deviation 97.72 |
| Chemo+Vaccine | Activation Profiles of NK Cells: NKp46 | Week 10 | 2435.9 Median Fluorescence Intensity | Standard Deviation 1237.85 |
| Chemo+Vaccine | Activation Profiles of NK Cells: NKp46 | Week 15 | 2600.82 Median Fluorescence Intensity | Standard Deviation 1161.2 |
| Chemo+Vaccine | Activation Profiles of NK Cells: NKp46 | Week 18 | 2352.18 Median Fluorescence Intensity | Standard Deviation 932.15 |
| Chemo+Vaccine | Activation Profiles of NK Cells: NKp46 | Week 23 | 1694.18 Median Fluorescence Intensity | Standard Deviation 754.75 |
| Chemo+Vaccine | Activation Profiles of NK Cells: NKp46 | Week 46 | 1785.4 Median Fluorescence Intensity | Standard Deviation 664.66 |
| Chemo+Vaccine | Activation Profiles of NK Cells: NKp46 | Week 70 | 1584.88 Median Fluorescence Intensity | Standard Deviation 452.15 |
| Chemo+Vaccine | Activation Profiles of NK Cells: NKp46 | Week 1 | 1206.5 Median Fluorescence Intensity | Standard Deviation 451.05 |
| Chemo+Vaccine | Activation Profiles of NK Cells: NKp46 | Week 7 | 1329.64 Median Fluorescence Intensity | Standard Deviation 578.46 |
Secondary
Activation Profiles of T Cells - CD69 on CD3+
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).
Time frame: Weeks 1, 7, 10, 15, 18, 23, 46, 70
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy Only | Activation Profiles of T Cells - CD69 on CD3+ | Week 46 | 382.33 Median Fluorescence Intensity (MFI) | Standard Deviation 68.12 |
| Chemotherapy Only | Activation Profiles of T Cells - CD69 on CD3+ | Week 7 | 403.2 Median Fluorescence Intensity (MFI) | Standard Deviation 62.35 |
| Chemotherapy Only | Activation Profiles of T Cells - CD69 on CD3+ | Week 1 | 368.8 Median Fluorescence Intensity (MFI) | Standard Deviation 31 |
| Chemo+Vaccine | Activation Profiles of T Cells - CD69 on CD3+ | Week 10 | 436 Median Fluorescence Intensity (MFI) | Standard Deviation 86.79 |
| Chemo+Vaccine | Activation Profiles of T Cells - CD69 on CD3+ | Week 15 | 412.27 Median Fluorescence Intensity (MFI) | Standard Deviation 154.74 |
| Chemo+Vaccine | Activation Profiles of T Cells - CD69 on CD3+ | Week 18 | 401.09 Median Fluorescence Intensity (MFI) | Standard Deviation 102.43 |
| Chemo+Vaccine | Activation Profiles of T Cells - CD69 on CD3+ | Week 23 | 396.73 Median Fluorescence Intensity (MFI) | Standard Deviation 54.14 |
| Chemo+Vaccine | Activation Profiles of T Cells - CD69 on CD3+ | Week 46 | 388.8 Median Fluorescence Intensity (MFI) | Standard Deviation 92.09 |
| Chemo+Vaccine | Activation Profiles of T Cells - CD69 on CD3+ | Week 70 | 333.38 Median Fluorescence Intensity (MFI) | Standard Deviation 34.1 |
| Chemo+Vaccine | Activation Profiles of T Cells - CD69 on CD3+ | Week 1 | 394.55 Median Fluorescence Intensity (MFI) | Standard Deviation 64.34 |
| Chemo+Vaccine | Activation Profiles of T Cells - CD69 on CD3+ | Week 7 | 411.27 Median Fluorescence Intensity (MFI) | Standard Deviation 63.6 |
Secondary
Fold Increase in P10s-MAP-Reactive Immunoglobulin Titers
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.
Time frame: Weeks 7, 10, 15, 18, 23, 46, and 70
Population: Chemotherapy Only and Chemo+Vaccine arms have different schedules of activities.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy Only | Fold Increase in P10s-MAP-Reactive Immunoglobulin Titers | Week 46 | 1 fold change in serum titer | Standard Deviation 0 |
| Chemotherapy Only | Fold Increase in P10s-MAP-Reactive Immunoglobulin Titers | Week 7 | 1 fold change in serum titer | Standard Deviation 0 |
| Chemo+Vaccine | Fold Increase in P10s-MAP-Reactive Immunoglobulin Titers | Week 10 | 3 fold change in serum titer | Standard Deviation 4.8 |
| Chemo+Vaccine | Fold Increase in P10s-MAP-Reactive Immunoglobulin Titers | Week 15 | 1.73 fold change in serum titer | Standard Deviation 2.1 |
| Chemo+Vaccine | Fold Increase in P10s-MAP-Reactive Immunoglobulin Titers | Week 18 | 1.36 fold change in serum titer | Standard Deviation 0.92 |
| Chemo+Vaccine | Fold Increase in P10s-MAP-Reactive Immunoglobulin Titers | Week 23 | 1.55 fold change in serum titer | Standard Deviation 1.21 |
| Chemo+Vaccine | Fold Increase in P10s-MAP-Reactive Immunoglobulin Titers | Week 46 | 5.4 fold change in serum titer | Standard Deviation 9.45 |
| Chemo+Vaccine | Fold Increase in P10s-MAP-Reactive Immunoglobulin Titers | Week 70 | 6.25 fold change in serum titer | Standard Deviation 10.69 |
| Chemo+Vaccine | Fold Increase in P10s-MAP-Reactive Immunoglobulin Titers | Week 7 | 2.27 fold change in serum titer | Standard Deviation 2.83 |
Secondary
Frequencies of Cells - CD69+/CD3+
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.
Time frame: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy Only | Frequencies of Cells - CD69+/CD3+ | Week 46 | 2.55 percentage of T cell | Standard Deviation 0.92 |
| Chemotherapy Only | Frequencies of Cells - CD69+/CD3+ | Week 7 | 2.52 percentage of T cell | Standard Deviation 1.54 |
| Chemotherapy Only | Frequencies of Cells - CD69+/CD3+ | Week 1 | 3.17 percentage of T cell | Standard Deviation 2.21 |
| Chemo+Vaccine | Frequencies of Cells - CD69+/CD3+ | Week 10 | 4.61 percentage of T cell | Standard Deviation 2.87 |
| Chemo+Vaccine | Frequencies of Cells - CD69+/CD3+ | Week 15 | 14.38 percentage of T cell | Standard Deviation 27.03 |
| Chemo+Vaccine | Frequencies of Cells - CD69+/CD3+ | Week 18 | 8.17 percentage of T cell | Standard Deviation 6.23 |
| Chemo+Vaccine | Frequencies of Cells - CD69+/CD3+ | Week 23 | 10.25 percentage of T cell | Standard Deviation 7.74 |
| Chemo+Vaccine | Frequencies of Cells - CD69+/CD3+ | Week 46 | 9 percentage of T cell | Standard Deviation 14.51 |
| Chemo+Vaccine | Frequencies of Cells - CD69+/CD3+ | Week 70 | 4.02 percentage of T cell | Standard Deviation 2 |
| Chemo+Vaccine | Frequencies of Cells - CD69+/CD3+ | Week 1 | 4.57 percentage of T cell | Standard Deviation 2.55 |
| Chemo+Vaccine | Frequencies of Cells - CD69+/CD3+ | Week 7 | 9.86 percentage of T cell | Standard Deviation 8.33 |
Secondary
Frequencies of Circulating Regulatory T Cells (Tregs)
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.
Time frame: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy Only | Frequencies of Circulating Regulatory T Cells (Tregs) | Week 7 | 10.8 percentage of Tcell CD4+CD25+CD127low/- | Standard Deviation 4.59 |
| Chemotherapy Only | Frequencies of Circulating Regulatory T Cells (Tregs) | Week 46 | 8.48 percentage of Tcell CD4+CD25+CD127low/- | Standard Deviation 1.7 |
| Chemotherapy Only | Frequencies of Circulating Regulatory T Cells (Tregs) | Week 1 | 9.68 percentage of Tcell CD4+CD25+CD127low/- | Standard Deviation 3.83 |
| Chemo+Vaccine | Frequencies of Circulating Regulatory T Cells (Tregs) | Week 70 | 9.37 percentage of Tcell CD4+CD25+CD127low/- | Standard Deviation 2.25 |
| Chemo+Vaccine | Frequencies of Circulating Regulatory T Cells (Tregs) | Week 10 | 8.26 percentage of Tcell CD4+CD25+CD127low/- | Standard Deviation 2.58 |
| Chemo+Vaccine | Frequencies of Circulating Regulatory T Cells (Tregs) | Week 15 | 8.82 percentage of Tcell CD4+CD25+CD127low/- | Standard Deviation 3.97 |
| Chemo+Vaccine | Frequencies of Circulating Regulatory T Cells (Tregs) | Week 23 | 5.75 percentage of Tcell CD4+CD25+CD127low/- | Standard Deviation 2.08 |
| Chemo+Vaccine | Frequencies of Circulating Regulatory T Cells (Tregs) | Week 46 | 12.88 percentage of Tcell CD4+CD25+CD127low/- | Standard Deviation 6.25 |
| Chemo+Vaccine | Frequencies of Circulating Regulatory T Cells (Tregs) | Week 1 | 9.04 percentage of Tcell CD4+CD25+CD127low/- | Standard Deviation 3.37 |
| Chemo+Vaccine | Frequencies of Circulating Regulatory T Cells (Tregs) | Week 7 | 5.27 percentage of Tcell CD4+CD25+CD127low/- | Standard Deviation 1.98 |
Secondary
Frequencies of NK Cells - CD16
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.
Time frame: Week 1, 7, 10, 15, 18, 23, 46, 70
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy Only | Frequencies of NK Cells - CD16 | Week 46 | 94.2 percentage of NK Cells | Standard Deviation 2.63 |
| Chemotherapy Only | Frequencies of NK Cells - CD16 | Week 7 | 66.72 percentage of NK Cells | Standard Deviation 32.41 |
| Chemotherapy Only | Frequencies of NK Cells - CD16 | Week 1 | 76.89 percentage of NK Cells | Standard Deviation 39.81 |
| Chemo+Vaccine | Frequencies of NK Cells - CD16 | Week 10 | 69.96 percentage of NK Cells | Standard Deviation 15.09 |
| Chemo+Vaccine | Frequencies of NK Cells - CD16 | Week 15 | 83.38 percentage of NK Cells | Standard Deviation 7.82 |
| Chemo+Vaccine | Frequencies of NK Cells - CD16 | Week 18 | 87.79 percentage of NK Cells | Standard Deviation 6.7 |
| Chemo+Vaccine | Frequencies of NK Cells - CD16 | Week 23 | 80.9 percentage of NK Cells | Standard Deviation 5 |
| Chemo+Vaccine | Frequencies of NK Cells - CD16 | Week 46 | 82.91 percentage of NK Cells | Standard Deviation 9.51 |
| Chemo+Vaccine | Frequencies of NK Cells - CD16 | Week 70 | 96.64 percentage of NK Cells | Standard Deviation 6.92 |
| Chemo+Vaccine | Frequencies of NK Cells - CD16 | Week 1 | 90.57 percentage of NK Cells | Standard Deviation 4.87 |
| Chemo+Vaccine | Frequencies of NK Cells - CD16 | Week 7 | 87.36 percentage of NK Cells | Standard Deviation 5.84 |
Secondary
Frequencies of NK Cells - CD69
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.
Time frame: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy Only | Frequencies of NK Cells - CD69 | Week 46 | 2.93 percentage of NK cells | Standard Deviation 1.21 |
| Chemotherapy Only | Frequencies of NK Cells - CD69 | Week 7 | 3.64 percentage of NK cells | Standard Deviation 1.71 |
| Chemotherapy Only | Frequencies of NK Cells - CD69 | Week 1 | 5.19 percentage of NK cells | Standard Deviation 2.06 |
| Chemo+Vaccine | Frequencies of NK Cells - CD69 | week 10 | 5.98 percentage of NK cells | Standard Deviation 2.49 |
| Chemo+Vaccine | Frequencies of NK Cells - CD69 | Week 15 | 15.73 percentage of NK cells | Standard Deviation 27.88 |
| Chemo+Vaccine | Frequencies of NK Cells - CD69 | Week 18 | 9.52 percentage of NK cells | Standard Deviation 7.28 |
| Chemo+Vaccine | Frequencies of NK Cells - CD69 | Week 23 | 11.21 percentage of NK cells | Standard Deviation 8.7 |
| Chemo+Vaccine | Frequencies of NK Cells - CD69 | Week 46 | 6.14 percentage of NK cells | Standard Deviation 3.35 |
| Chemo+Vaccine | Frequencies of NK Cells - CD69 | Week 70 | 3.98 percentage of NK cells | Standard Deviation 1.97 |
| Chemo+Vaccine | Frequencies of NK Cells - CD69 | Week 1 | 7.89 percentage of NK cells | Standard Deviation 5.98 |
| Chemo+Vaccine | Frequencies of NK Cells - CD69 | Week 7 | 13.54 percentage of NK cells | Standard Deviation 5.28 |
Secondary
Frequencies of NK Cells - NKG2D
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.
Time frame: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy Only | Frequencies of NK Cells - NKG2D | Week 46 | 86.93 percentage of NK cells | Standard Deviation 8.56 |
| Chemotherapy Only | Frequencies of NK Cells - NKG2D | Week 7 | 81.76 percentage of NK cells | Standard Deviation 6.54 |
| Chemotherapy Only | Frequencies of NK Cells - NKG2D | Week 1 | 90.88 percentage of NK cells | Standard Deviation 6.67 |
| Chemo+Vaccine | Frequencies of NK Cells - NKG2D | Week 10 | 78.34 percentage of NK cells | Standard Deviation 15.83 |
| Chemo+Vaccine | Frequencies of NK Cells - NKG2D | Week 15 | 91.66 percentage of NK cells | Standard Deviation 6.93 |
| Chemo+Vaccine | Frequencies of NK Cells - NKG2D | Week 18 | 91.04 percentage of NK cells | Standard Deviation 4.94 |
| Chemo+Vaccine | Frequencies of NK Cells - NKG2D | Week 23 | 91.91 percentage of NK cells | Standard Deviation 6.48 |
| Chemo+Vaccine | Frequencies of NK Cells - NKG2D | Week 46 | 89.33 percentage of NK cells | Standard Deviation 5.97 |
| Chemo+Vaccine | Frequencies of NK Cells - NKG2D | Week 70 | 91.46 percentage of NK cells | Standard Deviation 5.32 |
| Chemo+Vaccine | Frequencies of NK Cells - NKG2D | Week 1 | 93.74 percentage of NK cells | Standard Deviation 4.13 |
| Chemo+Vaccine | Frequencies of NK Cells - NKG2D | Week 7 | 89.26 percentage of NK cells | Standard Deviation 6.24 |
Secondary
Frequencies of NK Cells - NKp46
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.
Time frame: Weeks 1, 7, 10, 15, 18, 23, 46, and 70
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy Only | Frequencies of NK Cells - NKp46 | Week 46 | 77.13 percentage of NK cells | Standard Deviation 32.39 |
| Chemotherapy Only | Frequencies of NK Cells - NKp46 | Week 7 | 73.64 percentage of NK cells | Standard Deviation 25.66 |
| Chemotherapy Only | Frequencies of NK Cells - NKp46 | Week 1 | 87.98 percentage of NK cells | Standard Deviation 13.41 |
| Chemo+Vaccine | Frequencies of NK Cells - NKp46 | Week 10 | 70.35 percentage of NK cells | Standard Deviation 27.32 |
| Chemo+Vaccine | Frequencies of NK Cells - NKp46 | Week 15 | 87.77 percentage of NK cells | Standard Deviation 11.01 |
| Chemo+Vaccine | Frequencies of NK Cells - NKp46 | Week 18 | 90.15 percentage of NK cells | Standard Deviation 11.37 |
| Chemo+Vaccine | Frequencies of NK Cells - NKp46 | Week 23 | 82.19 percentage of NK cells | Standard Deviation 28 |
| Chemo+Vaccine | Frequencies of NK Cells - NKp46 | Week 46 | 86.84 percentage of NK cells | Standard Deviation 10.25 |
| Chemo+Vaccine | Frequencies of NK Cells - NKp46 | Week 70 | 90.31 percentage of NK cells | Standard Deviation 4.95 |
| Chemo+Vaccine | Frequencies of NK Cells - NKp46 | Week 1 | 77.98 percentage of NK cells | Standard Deviation 29.16 |
| Chemo+Vaccine | Frequencies of NK Cells - NKp46 | Week 7 | 83.36 percentage of NK cells | Standard Deviation 16.84 |
Secondary
Frequencies of T Cells - CD3+/CD4+
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.
Time frame: Weeks 1, 7, 10, 15, 18, 23, and 46
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy Only | Frequencies of T Cells - CD3+/CD4+ | Week 7 | 45.92 percentage of T cell | Standard Deviation 18.34 |
| Chemotherapy Only | Frequencies of T Cells - CD3+/CD4+ | Week 46 | 39.83 percentage of T cell | Standard Deviation 5.1 |
| Chemotherapy Only | Frequencies of T Cells - CD3+/CD4+ | Week 1 | 58.9 percentage of T cell | Standard Deviation 16.38 |
| Chemo+Vaccine | Frequencies of T Cells - CD3+/CD4+ | Week 10 | 46.59 percentage of T cell | Standard Deviation 12.37 |
| Chemo+Vaccine | Frequencies of T Cells - CD3+/CD4+ | Week 15 | 47.38 percentage of T cell | Standard Deviation 11.6 |
| Chemo+Vaccine | Frequencies of T Cells - CD3+/CD4+ | Week 18 | 48.57 percentage of T cell | Standard Deviation 10.19 |
| Chemo+Vaccine | Frequencies of T Cells - CD3+/CD4+ | Week 23 | 43.97 percentage of T cell | Standard Deviation 14.07 |
| Chemo+Vaccine | Frequencies of T Cells - CD3+/CD4+ | Week 46 | 43.66 percentage of T cell | Standard Deviation 13.72 |
| Chemo+Vaccine | Frequencies of T Cells - CD3+/CD4+ | Week 1 | 54.64 percentage of T cell | Standard Deviation 11.64 |
| Chemo+Vaccine | Frequencies of T Cells - CD3+/CD4+ | Week 7 | 59.89 percentage of T cell | Standard Deviation 10.91 |
Secondary
Frequencies of T Cells - CD3+/CD8+
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.
Time frame: Weeks 1, 7, 10, 15, 18, 23, and 46
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy Only | Frequencies of T Cells - CD3+/CD8+ | Week 7 | 46.46 percentage of T cell | Standard Deviation 15.78 |
| Chemotherapy Only | Frequencies of T Cells - CD3+/CD8+ | Week 46 | 53.03 percentage of T cell | Standard Deviation 3.85 |
| Chemotherapy Only | Frequencies of T Cells - CD3+/CD8+ | Week 1 | 33.68 percentage of T cell | Standard Deviation 12.88 |
| Chemo+Vaccine | Frequencies of T Cells - CD3+/CD8+ | Week 10 | 39.90 percentage of T cell | Standard Deviation 13.77 |
| Chemo+Vaccine | Frequencies of T Cells - CD3+/CD8+ | Week 15 | 44.95 percentage of T cell | Standard Deviation 9.22 |
| Chemo+Vaccine | Frequencies of T Cells - CD3+/CD8+ | Week 18 | 42.6 percentage of T cell | Standard Deviation 9.24 |
| Chemo+Vaccine | Frequencies of T Cells - CD3+/CD8+ | Week 23 | 46.84 percentage of T cell | Standard Deviation 15.6 |
| Chemo+Vaccine | Frequencies of T Cells - CD3+/CD8+ | Week 46 | 45.99 percentage of T cell | Standard Deviation 10.33 |
| Chemo+Vaccine | Frequencies of T Cells - CD3+/CD8+ | Week 1 | 35.62 percentage of T cell | Standard Deviation 11.78 |
| Chemo+Vaccine | Frequencies of T Cells - CD3+/CD8+ | Week 7 | 34.95 percentage of T cell | Standard Deviation 13.5 |