Melanoma
Conditions
Brief summary
The purpose of this study is to investigate a method of using dendritic cells (a kind of white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma cells.
Detailed description
This is a single arm open label trial that will assess the safety and tolerability of mature dendritic cell (mDC3/8) vaccine (primer and booster) in subjects with stage III and stage IV melanoma, followed by treatment with pembrolizumab (anti-PD-1 therapy). Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production approximately 1 week prior to vaccine infusion. Each study subject will receive cyclophosphamide 300mg/m\^2 intravenously or by mouth 3 to 4 days prior to the vaccine dose, to deplete regulatory T cells. For each vaccine dose, all subjects will receive autologous dendritic cells pulsed with melanoma tumor-specific peptides. On Day 1, the subject will receive the primer vaccine dose; this will be followed by two booster vaccine doses at 6 weeks apart. Peripheral blood will be taken weekly to monitor the immune response to each peptide by tetramer assay. Re-staging will occur after the 3rd vaccine dose, along with tumor biopsy and second apheresis. Anti PD-1 therapy (standard of care) will commence 7-8 weeks after the subject's last dendritic cell vaccine.
Interventions
BIOLOGICALMature dendritic cell (DC) vaccine
Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
DRUGCyclophosphamide 300mg/m^2
administered prior to subject's first DC dose
DRUGPembrolizumab
administered 7-8 weeks after subject's last DC dose
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed stage III and stage IV M1a/M1b/M1c melanoma. Measurable disease is not required for enrollment eligibility and patients with completely resected disease are permitted. * Male or female patients age greater than or equal to 18 years * ECOG (Eastern Cooperative Oncology Group) performance status 0-2 * Required initial laboratory values (performed within 14 days prior to eligibility confirmation by physician-investigator): * WBC (white blood cells) \>3,000/mm3 * Hg (hemoglobin) greater than or equal to 9.0 gm/dl * Platelets \>75,000/mm3 * Serum Bilirubin \< 2.0 mg/dl * Serum Creatinine \< 2.0 mg/dl * Subjects of reproductive potential must agree to use a medically accepted birth control method during the trial and for at least two months following the trial. * Provide written informed consent.
Exclusion criteria
* Prior treatment with more than one line of cytotoxic chemotherapy; prior treatment with one line of cytotoxic chemotherapy is permitted. Prior treatment with targeted therapy (such as ipilimumab, anti-PD1, or BRAF + MEK inhibitor combination) is permitted. * Active untreated CNS (central nervous system) metastasis * Active infection * Prior malignancy (except non-melanoma skin cancer) within 3 years * Pregnant or nursing (lactating) women * Concurrent treatment with high-dose systemic corticosteroids; local (inhaled or topical) steroids are permitted * Known allergy to eggs * Prior history of uveitis or autoimmune inflammatory eye disease * Known positivity for hepatitis B antibody, hepatitis C antibody, or HIV antibody
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Screening through week 21 | Immune response measuring increased numbers of peptide specific T cells as calculated by the tetramer assay. The numbers of Peptide Specific T Cells are reported as the percent of CD8+ T cells that were p/HLA multimer positive for each antigen. |
| Safety and Tolerability of the Mature Dendritic Cell Vaccine (mDC3/8 Vaccines). | End of Study visit (10-28 days after last DC vaccine) | Safety endpoint is type and number of adverse events. Tolerability endpoint is subject's completion or withdrawal from study treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response to the mDC3/8 Vaccine(s) | At the End of Study Treatment visit (~10-28 Days after the last DC vaccine) | using RECIST 1.1 |
| Time to Progression Post-mDC3/8 Vaccine Administration | Up to 30 weeks after the first mDC3/8 Vaccine | based on RECIST 1.1 criteria, until occurrence of a censoring event |
| Safety and Side Effect Profile of the Dendritic Cell Vaccine (mDC3/8 Vaccines) Administered to Patients Given After a Single Dose of Cyclophosphamide. | End of Study visit (10-28 days after last DC vaccine) | Assessed through collection of Adverse Events. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mature Dendritic Cell (DC) Vaccine Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Mature Dendritic Cell (DC) Vaccine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 5 / 5 |
| serious Total, serious adverse events | 1 / 5 |
Outcome results
Primary
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Immune response measuring increased numbers of peptide specific T cells as calculated by the tetramer assay. The numbers of Peptide Specific T Cells are reported as the percent of CD8+ T cells that were p/HLA multimer positive for each antigen.
Time frame: Screening through week 21
Population: Antigens for each subject may be different. Outcomes were not tested past week 21.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-3, wk 21 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-4, wk 21 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-1, wk 14-15 | 0.32 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-3, wk 14-15 | 5.68 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-5, wk 14-15 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-1, wk 17 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-2, screening | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-2, wk 17 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-1, screening | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-3, wk 17 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-3, screening | 0.26 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-4, wk 17 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-4, screening | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-5, wk 17 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-6, wk 17 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-5, screening | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-7, wk 17 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-1, wk 17 | 0.5 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-3, wk 17 | 1.81 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-4, wk 17 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-5, wk 17 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-1, wk 19 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-1, Day 1 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-2, wk 19 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-4, Day 1 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-3, wk 19 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-4, wk 19 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-2, Day 1 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-5, wk 19 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-4, screening | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-6, wk 19 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-7, wk 19 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-1, wk 19 | 0.32 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-3, wk 19 | 0.99 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-4, wk 19 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-5, wk 19 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-1, wk 21 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-3, Day 1 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-2, wk 21 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-1, screening | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-5, wk 21 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-6, wk 21 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-7, wk 21 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-1, wk 21 | 1.4 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-3, wk 21 | 0.16 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-4, wk 21 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-5, wk 21 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-5, Day 1 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-5, screening | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-6, Day 1 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-4, wk 14-15 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-7, Day 1 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-1, Day 1 | 0.4 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-3, Day 1 | 0.48 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-4, Day 1 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B8-5, Day 1 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-1, wk 14-15 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-2, wk 14-15 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-6, screening | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-3, wk 14-15 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-3, screening | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-4, wk 14-15 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-5, wk 14-15 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-6, wk 14-15 | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-7, screening | 0 percent of CD8+ T cells |
| Subject 1 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-7, wk 14-15 | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A31-2, wk 21 | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A31-2, wk 19 | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B15-2, wk 21 | 34.7 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B15-1, wk 19 | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B15-5, wk 21 | 33.9 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B15-3, wk 21 | 27.7 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A31-2, wk 17 | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B15-1, wk 17 | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B44-1, wk 21 | 17.4 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B15-1, screening | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B15-2, screening | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B15-3, screening | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B15-4, screening | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B15-5, screening | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B44-1, screening | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A31-1, screening | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A31-2, screening | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B15-1, day 1 | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B15-2, day 1 | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B15-3, day 1 | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B15-4, day 1 | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B15-5, day 1 | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B44-1, day 1 | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A31-1, day 1 | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A31-2, day 1 | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B15-1, wk 14 | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B15-2, wk 14 | 35 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B15-3, wk 14 | 27.2 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B15-4, wk 14 | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B15-5, wk 14 | 36.5 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B44-1, wk 14 | 22.7 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A31-1, wk 14 | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A31-2, wk 14 | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A31-1, wk 21 | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A31-1, wk 19 | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B15-1, wk 21 | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A31-1, wk 17 | 0 percent of CD8+ T cells |
| Subject 2 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen B15-4, wk 21 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-6, wk 21 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-1, screening | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-2, screening | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-3, screening | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-4, screening | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-5, screening | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-6, screening | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-7, screening | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-1, Day 1 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-2, Day 1 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-3, Day 1 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-4, Day 1 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-5, Day 1 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-6, Day 1 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-1, wk 14-15 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-2, wk 14-15 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-3, wk 14-15 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-4, wk 14-15 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-6, wk 14-15 | 2.4 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-1, wk 17 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-2, wk 17 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-3, wk 17 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-4, wk 17 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-6, wk 17 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-1, wk 19 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-2, wk 19 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-3, wk 19 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-4, wk 19 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-5, wk 19 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-6, wk 19 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-1, wk 21 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-2, wk 21 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-3, wk 21 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-4, wk 21 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-5, wk 21 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-8, screening | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-9, screening | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-10, screening | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-11, screening | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-8, day 1 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-9, day 1 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-10, day 1 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-11, day 1 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-8, wk 14 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-9, wk 14 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-11, wk 14 | 10.8 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-8, wk 17 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | 0Antigen A3-9, wk 17 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-10, wk 17 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-11, wk 17 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-8, wk 19 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-9, wk 19 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-10, wk 19 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-11, wk 19 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-8, wk 21 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-9, wk 21 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-10, wk 21 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-11, wk 21 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-10, wk 14 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-5, wk 14-15 | 0 percent of CD8+ T cells |
| Subject 3 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-5, wk 17 | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-13, day 1 | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-10, day 1 | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-12, wk 14 | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-11, day 1 | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-13, wk 14 | 1.48 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-8, wk 14 | 1.15 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-2, screening | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-9, wk 14 | 1.08 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-10, wk 14 | 0.9 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-3, screening | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-6, wk 14-15 | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-4, wk 14-15 | 4.01 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-3, wk 14-15 | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-2, wk 14-15 | 2.66 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-1, wk 14-15 | 0.86 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-6, Day 1 | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-5, Day 1 | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-4, Day 1 | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-3, Day 1 | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-2, Day 1 | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-1, Day 1 | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-6, screening | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-5, screening | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-4, screening | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-11, wk 14 | 0.14 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-8, screening | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-1, screening | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-9, screening | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-5, wk 14-15 | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-10, screening | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-12, screening | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-11, screening | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-13, screening | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-8, day 1 | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-12, day 1 | 0 percent of CD8+ T cells |
| Subject 4 | Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. | Antigen A3-9, day 1 | 0 percent of CD8+ T cells |
Primary
Safety and Tolerability of the Mature Dendritic Cell Vaccine (mDC3/8 Vaccines).
Safety endpoint is type and number of adverse events. Tolerability endpoint is subject's completion or withdrawal from study treatment.
Time frame: End of Study visit (10-28 days after last DC vaccine)
Population: Safety component is entered in the Adverse Events section.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subject 1 | Safety and Tolerability of the Mature Dendritic Cell Vaccine (mDC3/8 Vaccines). | Completed primary follow-up | 3 Participants |
| Subject 1 | Safety and Tolerability of the Mature Dendritic Cell Vaccine (mDC3/8 Vaccines). | Did not complete primary follow-up | 2 Participants |
Secondary
Clinical Response to the mDC3/8 Vaccine(s)
using RECIST 1.1
Time frame: At the End of Study Treatment visit (~10-28 Days after the last DC vaccine)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subject 1 | Clinical Response to the mDC3/8 Vaccine(s) | Progressive disease | 2 Participants |
| Subject 1 | Clinical Response to the mDC3/8 Vaccine(s) | Not evaluable | 3 Participants |
Secondary
Safety and Side Effect Profile of the Dendritic Cell Vaccine (mDC3/8 Vaccines) Administered to Patients Given After a Single Dose of Cyclophosphamide.
Assessed through collection of Adverse Events.
Time frame: End of Study visit (10-28 days after last DC vaccine)
Population: These outcome measures are entered in the Adverse Events section.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subject 1 | Safety and Side Effect Profile of the Dendritic Cell Vaccine (mDC3/8 Vaccines) Administered to Patients Given After a Single Dose of Cyclophosphamide. | 5 Participants |
Secondary
Time to Progression Post-mDC3/8 Vaccine Administration
based on RECIST 1.1 criteria, until occurrence of a censoring event
Time frame: Up to 30 weeks after the first mDC3/8 Vaccine
Population: Results are presented per subject.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subject 1 | Time to Progression Post-mDC3/8 Vaccine Administration | Subject 1 | 113 days |
| Subject 1 | Time to Progression Post-mDC3/8 Vaccine Administration | Subject 2 | NA days |
| Subject 1 | Time to Progression Post-mDC3/8 Vaccine Administration | Subject 3 | NA days |
| Subject 1 | Time to Progression Post-mDC3/8 Vaccine Administration | Subject 4 | NA days |
| Subject 1 | Time to Progression Post-mDC3/8 Vaccine Administration | Subject 5 | 80 days |