Colorectal Adenoma, Colorectal Carcinoma, Colorectal Conventional Adenoma With Severe Dysplasia, Colorectal Tubulovillous Adenoma
Conditions
Brief summary
This randomized phase II clinical trial studies how well MUC1 peptide-poly-ICLC adjuvant vaccine works in treating patients with newly diagnosed advanced colon polyps (adenomatous polyps). Adenomatous polyps are growths in the colon that may develop into colorectal cancer over time. Vaccines made from peptides may help the body build an effective immune response to kill polyp cells. MUC1 peptide-poly-ICLC adjuvant vaccine may also prevent the recurrence of adenomatous polyps and may prevent the development of colorectal cancer.
Detailed description
PRIMARY OBJECTIVES: I. To compare the immunogenicity at week 12 of a MUC1 peptide vaccine with adjuvant (MUC1 peptide-poly-ICLC adjuvant vaccine) (administered at 0, 2, and 10 weeks) in participants with a history of an advanced adenoma, randomized to receive MUC1 peptide vaccine versus placebo. SECONDARY OBJECTIVES: I. To evaluate the ability of the vaccine to elicit a long-term memory response. II. To compare the adenoma recurrence rate from surveillance exams occurring at least 1 year and up to 3 years after week 0 vaccine administration - MUC1 versus placebo. III. To compare the adenoma recurrence rates between MUC1 and placebo by excluding the following types of adenomas: participants with adenomas =\< 5 mm; participants with adenomatous tissue which may represent residual adenoma at the site of the previous advanced adenoma; participants with adenomatous tissue detected in the same segment of the bowel as the previous advanced adenoma. IV. To assess adverse events to the MUC1 peptide vaccine in comparison to placebo during Parts I and II. V. To assess patient reported injection site reaction events from the Vaccine Report Card. TERTIARY OBJECTIVES: I. To compare the anti-MUC1 antibody titer at the time of surveillance colonoscopy for the purpose of evaluating the anti-MUC1 antibody response in relation to adenoma recurrence. II. To evaluate MUC1 expression on baseline advanced adenomas and on recurrent adenomas detected at surveillance colonoscopy. III. To evaluate levels of circulating myeloid derived suppressor cells (MDSC) in the vaccinated and the placebo group and correlate with anti-MUC1 antibody levels and adenoma recurrence. IV. To establish a biospecimen repository archive including live cells, plasma, and germline deoxyribonucleic acid (DNA) for future immunologic (e.g. MUC1-specific T cells) and other assays (systems biology approach to detect differences between responders and non-responders), testing not currently accommodated within the budget of this trial. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Participants receive MUC1 peptide-poly-ICLC adjuvant vaccine subcutaneously (SC) in weeks 0, 2 and 10 and a booster injection in week 53. ARM II: Participants receive saline SC in weeks 0, 2, and 10 and a booster injection in week 53. After completion of treatment, patients are followed up every 6 months for up to 3 years.
Interventions
OTHERLaboratory Biomarker Analysis
Correlative studies
BIOLOGICALMUC1 Peptide-Poly-ICLC Vaccine
Given SC
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERSaline
Given SC
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* History of at least one of the following conditions in the previous 12 months: * Colorectal adenoma(s) \>= 1 cm in maximal diameter * Colorectal adenoma(s) with villous or tubulovillous histology * Colorectal adenoma(s) with high grade (severe) dysplasia * Presumptive evidence that all adenomatous lesions, including qualifying advanced adenoma, have been completely removed * Ability to understand and the willingness to sign a written informed consent document * Willingness to undergo screening tests and procedures * Willingness to provide blood samples for toxicity monitoring and research purposes * Not pregnant or nursing; note: a negative (serum or urine) pregnancy test must be documented =\< 7 days prior to registration/randomization for women of childbearing potential * Willingness to employ adequate contraception through week 53 of the study; note: women of childbearing potential and men must agree to use adequate contraception (hormonal, barrier method of birth control, abstinence) prior to study entry and for the period of active vaccination (through week 53); should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her physician immediately * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%) * Hemoglobin greater than 90% of the lower limit of institutional normal * Platelets \>= 100 B/L (10\^9/L) * White blood cell (WBC) \> 2.5 B/L (10\^9/L) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]), alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 x institutional upper limit of normal * Alkaline phosphatase =\< 1.5 x institutional upper limit of normal * Total bilirubin =\< 1.5 x institutional upper limit of normal * Blood urea nitrogen (BUN) =\< 1.5 x institutional upper limit of normal * Creatinine =\< 1.5 x institutional upper limit of normal * Antinuclear antibody (ANA) test result excludes overt autoimmune disease; note: test result may be reported in any of the following formats: =\< 1:160, negative, or \< 1.0
Exclusion criteria
* History of any colorectal cancer * History of other malignancy =\< 5 years prior to the registration/randomization evaluation, with the exception of basal cell or squamous cell skin cancer * Presence of an active acute or chronic infection or uncontrolled illness including, but not limited to unstable congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Acquired immunosuppressive diseases such as active human immunodeficiency virus (HIV) infection or congenital diseases of immunity * History of heritable cancer syndrome (familial adenomatous polyposis \[FAP\], hereditary nonpolyposis colorectal cancer \[HNPCC\]) * History of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, multiple sclerosis, Hashimoto's thyroiditis, or Grave's disease * Current or planned use of immunomodulators including: infliximab, 6-MP (mercaptopurine), methotrexate, cyclosporine, or other immunomodulatory drugs * History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent * Pregnant women * Breastfeeding women * Diagnosis of nonalcoholic steatohepatitis (NASH) and a NAFLD (nonalcoholic fatty liver disease) activity score (NAS) \>= 5; NOTES and EXCEPTIONS: NAS is based on findings from a liver biopsy; participants with NAS of =\< 2 are eligible for enrollment; participants with NAS of 3-4 must be discussed with the principal investigator and Division of Cancer Prevention (DCP) before enrollment to consider other risk factors (i.e., obesity, alcohol intake); participants with a prior diagnosis of NASH and no available NAS must be discussed with the principal investigator and DCP before enrollment to considered risk factors (i.e., obesity, alcohol intake) * Receiving any other investigational agent =\< 3 months prior to registration/randomization, except innocuous agents with no known interaction with the study agent (e.g., standard dose multivitamins or topical agents for limited skin conditions) * Any use of oral corticosteroids =\< 12 weeks prior to registration/randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anti-MUC1 Immunoglobulin G (IgG) Levels as Determined by Enzyme-linked Immunosorbent Assay (ELISA) | Week 0 to week 12 | The ratio of the week 12 to week 0 IgG levels will be calculated and compared between the MUC1 vaccine and placebo. The Wilcoxon Rank-Sum test will be used. For all measurements of response (i.e. the primary endpoint), the 95% confidence intervals will also be provided. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma Recurrence Rate | At least one year and up to 3 years | The secondary endpoint for Part 3 will evaluate the adenoma recurrence rate from surveillance exams. The rate is defined as the percentage of participants with adenoma recurrence. |
| Booster Response | At week 55 | The key secondary endpoint for Part 2 will assess the booster response at week 55 vs. week 52 for the vaccine as compared to placebo. The IgG ratios are summarized according to the following categories : \<1, 1-\<1.5, 1.5-\<2, and \>=2 (1-year response rate). |
| Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Up to 55 weeks | Participant-reported injection site reaction information is collected by the use of a participant-completed Vaccine Report Card. Participant-reported injection site reactions will be compared between study arms and are summarized below for redness at the injection site, swelling/induration, itching at site, and skin warmth at site. |
| Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch) | Up to 55 weeks | Participant-reported injection site reaction information is collected by the use of a participant-completed Vaccine Report Card. Participant-reported injection site reactions will be compared between study arms and are summarized below for pain at the injection site without touching, and tenderness (pain at the injection site with touch). |
| Number of Patients With at Least a 2-Fold Increase in the IgG Ratio | At 12 weeks | The frequency and percentage of patients with at least a 2-fold increase in the IgG Ratio will be calculated and compared between the MUC1 vaccine and placebo. The Fisher's exact test will be used. |
Countries
Puerto Rico, United States
Contacts
PRINCIPAL_INVESTIGATORRobert E Schoen
Mayo Clinic
Participant flow
Recruitment details
For the baseline discrepancy, we projected to enroll 120 patients originally, but only enrolled 110 in the end. Of the 110, only 102 completed the study and were evaluable for the primary endpoint. Of the 8 dropouts, 7 were cancels and 1 patient was a "withdrawal by subject".
Participants by arm
| Arm | Count |
|---|---|
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) Participants receive 300 microliters of MUC1 peptide vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53. | 52 |
| Arm II (Placebo) Participants receive identical-appearing placebo injection in weeks 0, 2, and 10 and a booster injection in week 53. | 50 |
| Total | 102 |
Baseline characteristics
| Characteristic | Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Total | Arm II (Placebo) |
|---|---|---|---|
| Age, Continuous | 59.5 years | 59.5 years | 59.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 19 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 82 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Performance status (PS) 0 | 49 Participants | 95 Participants | 46 Participants |
| Performance status (PS) 1 | 3 Participants | 7 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 9 Participants | 5 Participants |
| Race/Ethnicity, Customized Unknown: Patient unsure | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 47 Participants | 90 Participants | 43 Participants |
| Sex: Female, Male Female | 20 Participants | 40 Participants | 20 Participants |
| Sex: Female, Male Male | 32 Participants | 62 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 50 |
| other Total, other adverse events | 51 / 53 | 37 / 50 |
| serious Total, serious adverse events | 12 / 53 | 8 / 50 |
Outcome results
Primary
Change in Anti-MUC1 Immunoglobulin G (IgG) Levels as Determined by Enzyme-linked Immunosorbent Assay (ELISA)
The ratio of the week 12 to week 0 IgG levels will be calculated and compared between the MUC1 vaccine and placebo. The Wilcoxon Rank-Sum test will be used. For all measurements of response (i.e. the primary endpoint), the 95% confidence intervals will also be provided.
Time frame: Week 0 to week 12
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Change in Anti-MUC1 Immunoglobulin G (IgG) Levels as Determined by Enzyme-linked Immunosorbent Assay (ELISA) | 1.2 IgG ratio |
| Arm II (Placebo) | Change in Anti-MUC1 Immunoglobulin G (IgG) Levels as Determined by Enzyme-linked Immunosorbent Assay (ELISA) | 1.0 IgG ratio |
p-value: 0.0004Wilcoxon (Mann-Whitney)
Secondary
Adenoma Recurrence Rate
The secondary endpoint for Part 3 will evaluate the adenoma recurrence rate from surveillance exams. The rate is defined as the percentage of participants with adenoma recurrence.
Time frame: At least one year and up to 3 years
Population: Participants who completed the surveillance exams were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Adenoma Recurrence Rate | 56.3 percentage of participants |
| Arm II (Placebo) | Adenoma Recurrence Rate | 66.0 percentage of participants |
Secondary
Booster Response
The key secondary endpoint for Part 2 will assess the booster response at week 55 vs. week 52 for the vaccine as compared to placebo. The IgG ratios are summarized according to the following categories : \<1, 1-\<1.5, 1.5-\<2, and \>=2 (1-year response rate).
Time frame: At week 55
Population: Participants with IgG levels at week 52 and 55 are included in this analysis
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Booster Response | 1.5- <2 | 2 Participants |
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Booster Response | >=2 (1-Year Response Rate) | 17 Participants |
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Booster Response | 1- <1.5 | 15 Participants |
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Booster Response | <1 | 17 Participants |
| Arm II (Placebo) | Booster Response | <1 | 18 Participants |
| Arm II (Placebo) | Booster Response | 1.5- <2 | 2 Participants |
| Arm II (Placebo) | Booster Response | 1- <1.5 | 22 Participants |
| Arm II (Placebo) | Booster Response | >=2 (1-Year Response Rate) | 2 Participants |
Secondary
Number of Patients With at Least a 2-Fold Increase in the IgG Ratio
The frequency and percentage of patients with at least a 2-fold increase in the IgG Ratio will be calculated and compared between the MUC1 vaccine and placebo. The Fisher's exact test will be used.
Time frame: At 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Number of Patients With at Least a 2-Fold Increase in the IgG Ratio | 13 Participants |
| Arm II (Placebo) | Number of Patients With at Least a 2-Fold Increase in the IgG Ratio | 0 Participants |
p-value: 0.0001Fisher Exact
Secondary
Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch)
Participant-reported injection site reaction information is collected by the use of a participant-completed Vaccine Report Card. Participant-reported injection site reactions will be compared between study arms and are summarized below for pain at the injection site without touching, and tenderness (pain at the injection site with touch).
Time frame: Up to 55 weeks
Population: Participants who completed Vaccine Report Card are included in this analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch) | Pain at the injection site without touching | A lot | 1 Participants |
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch) | Pain at the injection site without touching | Some | 3 Participants |
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch) | Pain at the injection site without touching | A little | 33 Participants |
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch) | Pain at the injection site without touching | None | 16 Participants |
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch) | Tenderness (pain at the injection site with touch) | A lot | 3 Participants |
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch) | Tenderness (pain at the injection site with touch) | Some | 7 Participants |
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch) | Tenderness (pain at the injection site with touch) | A little | 32 Participants |
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch) | Tenderness (pain at the injection site with touch) | None | 11 Participants |
| Arm II (Placebo) | Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch) | Tenderness (pain at the injection site with touch) | None | 47 Participants |
| Arm II (Placebo) | Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch) | Pain at the injection site without touching | A lot | 0 Participants |
| Arm II (Placebo) | Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch) | Tenderness (pain at the injection site with touch) | A lot | 0 Participants |
| Arm II (Placebo) | Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch) | Pain at the injection site without touching | Some | 0 Participants |
| Arm II (Placebo) | Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch) | Tenderness (pain at the injection site with touch) | A little | 3 Participants |
| Arm II (Placebo) | Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch) | Pain at the injection site without touching | A little | 0 Participants |
| Arm II (Placebo) | Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch) | Tenderness (pain at the injection site with touch) | Some | 0 Participants |
| Arm II (Placebo) | Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch) | Pain at the injection site without touching | None | 50 Participants |
Secondary
Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site
Participant-reported injection site reaction information is collected by the use of a participant-completed Vaccine Report Card. Participant-reported injection site reactions will be compared between study arms and are summarized below for redness at the injection site, swelling/induration, itching at site, and skin warmth at site.
Time frame: Up to 55 weeks
Population: Participants who completed the Vaccine Report Card are included in this analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Redness at the injection site | None | 12 Participants |
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Itching at site | Yes | 17 Participants |
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Swelling/induration | Yes | 30 Participants |
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Itching at site | None | 31 Participants |
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Redness at the injection site | Yes | 36 Participants |
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Itching at site | Missing | 5 Participants |
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Swelling/induration | None | 18 Participants |
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Redness at the injection site | Missing | 5 Participants |
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Skin warmth at site | None | 19 Participants |
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Swelling/induration | Missing | 5 Participants |
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Skin warmth at site | Missing | 5 Participants |
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Skin warmth at site | Yes | 29 Participants |
| Arm II (Placebo) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Skin warmth at site | Missing | 4 Participants |
| Arm II (Placebo) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Redness at the injection site | Yes | 2 Participants |
| Arm II (Placebo) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Redness at the injection site | None | 44 Participants |
| Arm II (Placebo) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Redness at the injection site | Missing | 4 Participants |
| Arm II (Placebo) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Swelling/induration | Yes | 0 Participants |
| Arm II (Placebo) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Swelling/induration | None | 46 Participants |
| Arm II (Placebo) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Swelling/induration | Missing | 4 Participants |
| Arm II (Placebo) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Itching at site | Yes | 1 Participants |
| Arm II (Placebo) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Itching at site | None | 45 Participants |
| Arm II (Placebo) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Itching at site | Missing | 4 Participants |
| Arm II (Placebo) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Skin warmth at site | Yes | 3 Participants |
| Arm II (Placebo) | Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site | Skin warmth at site | None | 43 Participants |
Other Pre-specified
Anti-MUC1 Antibody Titer by ELISA
Comparisons between MUC1 and placebo will be performed using a two-sample t-test or Wilcoxon rank sum test, as appropriate. All categorical variables will be analyzed using chi-square tests or Fisher's exact test.
Time frame: At approximately week 156
Other Pre-specified
Change in Levels of Circulating MDSC in Peripheral Blood Mononuclear Cells by Flow Cytometry
MDSC levels will be correlated with anti-MUC1 antibody levels and adenoma recurrence. Descriptive statistics and simple scatter plots will be generated to review the continuous biomarker data. In addition, for continuous biomarker values, the actual and percent change in the level of each of the biomarkers from baseline to post-baseline time points will be explored within each arm using Wilcoxon signed rank tests, and paired sample t-tests.
Time frame: Baseline to up to 3 years
Other Pre-specified
Change in MUC1 Expression
Descriptive statistics and simple scatter plots will be generated to review the continuous biomarker data. In addition, for continuous biomarker values, the actual and percent change in the level of each of the biomarkers from baseline to post-baseline time points will be explored within each arm using Wilcoxon signed rank tests, and paired sample t-tests.
Time frame: Baseline to up to 3 years
Other Pre-specified
Establishment of a Biospecimen Repository Archive Including Live Cells, Plasma, and Germline DNA for Future Immunologic and Other Assays
Time frame: Up to 3 years
Other Pre-specified
Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0.
Time frame: Up to 3 years