Colorectal Cancer
Conditions
Keywords
colorectal cancer, cancer vaccine, dendritic cell vaccine
Brief summary
This is a pilot study to assess the safety and tolerability, as well as the immune response rate, of mDC3 vaccine in patients with colorectal cancer.
Detailed description
This is a pilot study to assess the safety and tolerability, as well as the immune response rate, of mDC3 vaccine in patients with colorectal cancer. 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 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 mutated peptides. On Day 1, the subject will receive the primer vaccine dose; this will be followed by one booster vaccine dose approximately 8 weeks later. Peripheral blood will be taken weekly, and a second apheresis procedure will be performed at the end of study to monitor the immune response to the vaccine. Information will be gathered from usual clinic visits for approximately 1 year following the End of Treatment Study Visit to evaluate for disease progression.
Interventions
BIOLOGICALDC vaccine
DC vaccine for colorectal cancer
Sponsors
Parker Institute for Cancer Immunotherapy
National Cancer Institute (NCI)
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
* Pathologically-confirmed stage I and II hypermutated colorectal cancer (CRC) * Surgically resected disease * Male or female patients 18+ years of age * ECOG performance status 0-1 * Certain laboratory values, performed within 14 days prior to consent * 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 malignancy within 3 years that may put subject at risk * Pregnant or nursing women * Concurrent treatment with systemic immunosuppressants including corticosteroids, calcineurin inhibitors, antiproliferative agents within 2 weeks of consent. Local (inhaled or topical) steroids or replacement dose prednisone are permitted. * Known allergy to eggs * Any uncontrolled intercurrent illness or active ongoing infection thta may put subject at additional risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening, Day 1, Day 43, Day 85. Also at following timepoints, which will vary by subject: 7-14 days after last vaccine; 30 days after last vaccine; every 3 months beginning 6 months since first vaccine until month 12. | Assessment of cellular immune activity may occur via the application of flow cytometry. Numbers of peptide-specific CD8+ T cells will be measured by flow cytometric-based intracellular cytokine or tetramer staining. Flow cytometric assays will include an examination of the influence of immunotherapy on the ability of subject T cells to exhibit phenotypic markers associated with cytolytic potential (e.g. IFN-y, IL-2, TNF-alpha, Granzyme B) after short-term stimulation by mutated peptide and p-HLA multimer staining. PBMC responses against a pool of known antigenic Cytomegalovirus, Epstein Barr Virus and Influenza epitopes will be evaluated in order to track general cellular immune competence during the study. |
| Adverse Events Experienced by Subjects (i.e. Safety of DC Vaccine in Subjects With Surgically Resected Hypermutated CRC) | Through study completion (at 12 months) | Number of subjects who experienced adverse events. Detailed adverse event data is presented in the AE section. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of CD8+ Cells in Primary Tumor Tissue | Screening, Day 1, Day 43, Day 85. Also at following timepoints, which will vary by subject: 7-14 days after last vaccine; 30 days after last vaccine; every 3 months beginning 6 months since first vaccine until month 12. | Descriptive models |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All subjects will receive the vaccine and be followed per the schedule of procedures.
DC vaccine: DC vaccine for colorectal cancer | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 2 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 | 1 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 4 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Adverse Events Experienced by Subjects (i.e. Safety of DC Vaccine in Subjects With Surgically Resected Hypermutated CRC)
Number of subjects who experienced adverse events. Detailed adverse event data is presented in the AE section.
Time frame: Through study completion (at 12 months)
Population: The number of participants includes 1 subject who began the study but did not complete it.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subject 01, Antigen TBCC1D23 K632X | Adverse Events Experienced by Subjects (i.e. Safety of DC Vaccine in Subjects With Surgically Resected Hypermutated CRC) | 3 participants |
Primary
Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response)
Assessment of cellular immune activity may occur via the application of flow cytometry. Numbers of peptide-specific CD8+ T cells will be measured by flow cytometric-based intracellular cytokine or tetramer staining. Flow cytometric assays will include an examination of the influence of immunotherapy on the ability of subject T cells to exhibit phenotypic markers associated with cytolytic potential (e.g. IFN-y, IL-2, TNF-alpha, Granzyme B) after short-term stimulation by mutated peptide and p-HLA multimer staining. PBMC responses against a pool of known antigenic Cytomegalovirus, Epstein Barr Virus and Influenza epitopes will be evaluated in order to track general cellular immune competence during the study.
Time frame: Screening, Day 1, Day 43, Day 85. Also at following timepoints, which will vary by subject: 7-14 days after last vaccine; 30 days after last vaccine; every 3 months beginning 6 months since first vaccine until month 12.
Population: Results are reported as IFN-G producing cells / 5x10\^5 cells, all CD3+ T cells. Neither subject was tested at 6 months, 9 months, or 12 months time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subject 01, Antigen TBCC1D23 K632X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 201 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen TBCC1D23 K632X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen TBCC1D23 K632X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen TBCC1D23 K632X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 325 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen TBCC1D23 K632X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 53 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen TBCC1D23 K632X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen CDC7 L28X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen CDC7 L28X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen CDC7 L28X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen CDC7 L28X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen CDC7 L28X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 1 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen CDC7 L28X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen MSH3 K381X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 1159 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen MSH3 K381X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 253 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen MSH3 K381X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen MSH3 K381X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 33 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen MSH3 K381X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 234 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen MSH3 K381X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 286 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen NKTR 613-614X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen NKTR 613-614X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 13 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen NKTR 613-614X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 167 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen NKTR 613-614X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen NKTR 613-614X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen NKTR 613-614X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 312 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen DDX51 P492L | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen DDX51 P492L | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 306 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen DDX51 P492L | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 27 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen DDX51 P492L | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 65 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen DDX51 P492L | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 55 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen DDX51 P492L | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 461 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen APC A885X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 240 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen APC A885X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 352 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen APC A885X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 280 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen APC A885X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 36 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen APC A885X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen APC A885X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 697 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen TCERG1 R889X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen TCERG1 R889X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen TCERG1 R889X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen TCERG1 R889X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen TCERG1 R889X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen TCERG1 R889X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen MAP3K21 A767V | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 34 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen MAP3K21 A767V | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen MAP3K21 A767V | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen MAP3K21 A767V | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen MAP3K21 A767V | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen MAP3K21 A767V | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen DAG1 W31R | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 85 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen DAG1 W31R | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 9 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen DAG1 W31R | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 43 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen DAG1 W31R | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen DAG1 W31R | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen DAG1 W31R | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen ZC3H18 A886V | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen ZC3H18 A886V | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 1339 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen ZC3H18 A886V | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 650 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen ZC3H18 A886V | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 432 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen ZC3H18 A886V | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 331 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen ZC3H18 A886V | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 1250 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen PRR11 K20X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen PRR11 K20X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 5 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen PRR11 K20X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen PRR11 K20X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 10 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen PRR11 K20X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 10 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen PRR11 K20X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen MSH6 Q657H | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 17 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen MSH6 Q657H | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen MSH6 Q657H | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen MSH6 Q657H | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen MSH6 Q657H | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 3 IFN-G producing cells / 5x10^5 cells |
| Subject 01, Antigen MSH6 Q657H | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen DOCK3 T1850X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen DOCK3 T1850X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 5 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen DOCK3 T1850X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 5 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen DOCK3 T1850X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 12 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen DOCK3 T1850X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen DOCK3 T1850X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FAM214BA42X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FAM214BA42X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 4 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FAM214BA42X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FAM214BA42X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FAM214BA42X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FAM214BA42X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FHDC1F100X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FHDC1F100X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FHDC1F100X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 43 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FHDC1F100X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FHDC1F100X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 19 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FHDC1F100X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 5 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen DOCK1E1616X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 10 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen DOCK1E1616X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen DOCK1E1616X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen DOCK1E1616X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen DOCK1E1616X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen DOCK1E1616X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 8 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen PLA2G6 S359L | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 5 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen PLA2G6 S359L | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 5 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen PLA2G6 S359L | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen PLA2G6 S359L | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen PLA2G6 S359L | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 34 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen PLA2G6 S359L | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen POLG2K160E | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen POLG2K160E | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen POLG2K160E | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen POLG2K160E | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen POLG2K160E | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 2 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen POLG2K160E | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen LYSMD3 V111A | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 2 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen LYSMD3 V111A | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 1 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen LYSMD3 V111A | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 38 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen LYSMD3 V111A | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen LYSMD3 V111A | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 5 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen LYSMD3 V111A | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FARR459H | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 29 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FARR459H | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FARR459H | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FARR459H | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FARR459H | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 8 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FARR459H | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen PDHXI190L | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 789 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen PDHXI190L | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 289 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen PDHXI190L | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 414 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen PDHXI190L | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen PDHXI190L | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 500 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen PDHXI190L | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 9 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FNIP2 K575E | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 453 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FNIP2 K575E | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 491 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FNIP2 K575E | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FNIP2 K575E | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 255 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FNIP2 K575E | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen FNIP2 K575E | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 75 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen ARID1AG284X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen ARID1AG284X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen ARID1AG284X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen ARID1AG284X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 20 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen ARID1AG284X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 15 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen ARID1AG284X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 0 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen ACVR2AK435X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 30 days after last vaccine | 2 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen ACVR2AK435X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 85 (week 12) | 237 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen ACVR2AK435X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 43 (week 6) | 618 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen ACVR2AK435X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | 7-14 days after last vaccine (week 14) | 80 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen ACVR2AK435X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Day 1 | 9 IFN-G producing cells / 5x10^5 cells |
| Subject 02, Antigen ACVR2AK435X | Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) | Screening | 0 IFN-G producing cells / 5x10^5 cells |
Secondary
Percentage of CD8+ Cells in Primary Tumor Tissue
Descriptive models
Time frame: Screening, Day 1, Day 43, Day 85. Also at following timepoints, which will vary by subject: 7-14 days after last vaccine; 30 days after last vaccine; every 3 months beginning 6 months since first vaccine until month 12.
Population: Per protocol, tissue samples will be used if obtained as part of standard of care procedures only. No samples were collected as part of standard of care procedures, therefore no analysis could be performed.